Spotlight D; Dietary Supplements Flashcards
study participants who were developing cancer were the ones taking the beta-carotene - not the ones taking placebos
the cancer agency confirmed that beta-carotene had increased lung cancer risk by [..]% compared with the placebo in the Finnish trial, although vitamin E seemed to have no effect
18%
Ommens research findings; the combination of beta-carotene and vitamin A was increasing his participants’ risk of lung cancer by a whopping 28% compared with sugar pills
people have a 1 in 1000 increased chance of developing cancer each year as a direct each year as a direct result of taking the beta-carotene/vitamin A supplements
supplements can be beneficial for some individuals, particularly those who cannot meet their nutritional requirements because of disease, increased need, or restricted diets. but many people take supplements despite the fact that they are already in good health and likely to get adequate nutrients through their diet
a growing body of research, including the results of those National Cancer institute trials from the 1990s suggest that supplementation with single vitamins or other dietary components, especially amounts above recommended intake levels, may offer little benefit at best and may pose health risks at worst
women are more likely to take supplements to keep their [..] healthy, whereas men tend to pop pills in the hope of preventing [..] problems
bones
heart
the majority of studies have found that multivitamin/mineral (MVM) supplement use does not decrease the risk of death of chronic disease and has little benefit, if any, for those who already meet nutrient needs through their regular diet.
people who take supplements tend to have healthier habits and more favorable health indicators (for example, has normal blood pressure, has a healthy body weight, and is a nonsmoker) than those who do not take supplements.
those who might benefit the most from supplementation are, ironically, often the ones who are [..] likely to take them
least
as defined by congress in the 1994 dietary supplement health and education act (DSHEA), dietary supplements are intended to be taken by mouth and contain one or more dietary ingredients or their constituents; vitamins, minerals, herbs or other botanicals; amino acids; or other dietary substances such as enzymes
the diverse array of products containing these ingredients and constituents are grouped together and called “dietary supplements” because they are regulated by a common set of regulations/.
any substance that is found in any food, even if present only in minute quantities, can be extracted or concentrated in the forms of pills, capsules, tablets, liquids, powders, and bars and then sold as a dietary supplement. therefore, these substances are commonly being consumed at levels far exceeding those over achieved form the intake of food alone
for the average person, the academy of nutrition and dietetics recommends that the best nutrition based strategy for health is to eat a wide [..] of foods.
variety
some populations may benefit from using dietary supplements. for example, women who have heavy menstrual bleeding may need supplemental iron, and people who have had procedures that interfere with nutrient supplements, such as gastric bypass surgery, may need particular nutrient supplements.
nutrient supplementation of some specific nutrients may also be warranted during certain life stages (for instance, the increased nutrient demands of pregnancy and lactation as well as the impact of physiological changes associated with aging that impact nutrient intake and absorption)
dietary concerns, infants and children;
(circumstances that may warrant nutrient supplementation)
breastfed children and any child consuming less than 1 qt/day of vitamin D-fortified milk should receive a vitamin D supplement
dietary concerns, women who may become pregnant;
(circumstances that may warrant nutrient supplementation)
supplemental folic acid reduces the occurrence of neural tube defects
dietary concerns, pregnant women
(circumstances that may warrant nutrient supplementation)
a folid acid supplement is recommended during pregnancy. a multivitamin/mineral (MVM) supplement is recommended for anemia, women carrying multiple fetuses, or women consuming little or no animal proteins
dietary concerns; vegans;
(circumstances that may warrant nutrient supplementation)
the only source of B12 is animal proteins and fortified foods, so vegans who eat no animal products may need a supplement as well as supplementary calcium, iron, and zinc
dietary concerns; those who do not consume dairy products;
(circumstances that may warrant nutrient supplementation)
because milk and other dairy products are an important source of vitamin D and calcium, a supplement providing theses nutrients may improve bone health.
dietary concerns, adults older than 50 years ;
(circumstances that may warrant nutrient supplementation)
B12 and vitamin D supplements are recommended because B12 absorption tends to decline with age and older individuals synthesize less vitamin D when exposed to UV light
dietary concerns, those with dark skins;
(circumstances that may warrant nutrient supplementation)
vitamin D supplement are recommended because skin pigments block UV light and decrease the synthesis of vitamin D
dietary concerns, individuals on restricted diets;
(circumstances that may warrant nutrient supplementation)
those with low food intake or limited food choices may benefit from an MVM supplement
dietary concerns; individuals who smoke, alcohol dependent individuals, and those taking some medications;
(circumstances that may warrant nutrient supplementation)
nutrient absorption, utilization, and excretion can be affect by prescription or recreational drug use. therefore, an MVM supplement may be warranted.
dietary concerns; women who are pregnant; women with heavy menstrual periods; individuals who frequently donate blood, as well as those with some stomach and intestinal conditions (food sensitivity, hookworms)
(circumstances that may warrant nutrient supplementation)
iron supplementation may be necessary
the Food and Drug Administration (FDA) regulates both dietary supplement products and the ingredients found within them, and it does so under a different set of regulations than those governing “conventional” foods and drugs
unlike drug regulation, the FDA does not approve dietary supplements for their [..] or [..] before they are made available to consumers. (dietary supplements do not undergo the rigorous testing for effectiveness, interaction, or safety requirements that prescription and over the counter drugs do)
effectiveness
safety
the manufacturers of a dietary supplement or ingredient is responsible for ensuring that the product is safe, unaldulterated, produced with good manufacturing practices, and properly and truthfully marked with a label that identifies the product as a dietary supplement and that the product includes specific information about the supplement and its use
basically, the manufacturer (maker) has to make sure and provide accurate information on the product while ensuring it is safe, and made well.
although dietary ingredients found in supplements are federally regulated, ingredients and additives that were already found in the food supply prior to when DSHEA went into effect on October 15, 1994, were grandfathered in as “generally recognized as safe” (GRAS). GRAS substances don’t need FDA approval before being marketed , so many long standing supplement ingredients have not undergone FDA scrutiny for safety
basically, the GRAS ingredients, generally recognized as safe, before the date ingredients that were being used of that time, as considered safe and don’t need FDA approval
for new dietary ingredients, DSHEA requires that manufacturers must notify the FDA [..] days before the product is to be introduced and provide the agency with evidence that the supplement is “reasonably expected to be safe”.
unfortunately, it is common for supplement distributors and manufacturers to ignore this requirement as well as other regulations
75
basically; if trying to implement a new product that hasn’t been considered GRAS , FDA approved, you must notify the FDA 75 days before the product is released. must provide evidence that the supplement is safe. many manufacturers ignore this.
because the FDA does not regulate dietary supplements as rigorously as it does drugs, supplements are sometimes sold contaminated with banned substances or prescription drugs.
FDA Regulations Governing the Introduction of New Dietary Ingredients in Supplements; Current Enforced Regulations
- manufacturers must submit information to the FDA regarding “safety and efficacy” of a dietary supplement containing a new dietary ingredient
- the manufacturer need only demonstrate that the new dietary ingredient can “reasonably be expected to be safe” by providing some evidence of safety but not actually proving safety
- the FDA does not approve new dietary ingredients or supplements - they are free to be marketed 75 days after the information was submitted to the FDA
FDA Regulations Governing the Introduction of New Dietary Ingredients in Supplements; Current FDA Recommendations - Unenforced
- Safety must be established by a documented history of use at the same or higher dosage, frequency, and duration of use
- laboratory or animal studies would be required for products marketed for consumption at higher than historical intakes
- no human studies are required, even for substances without any documented historical use
FDA requires that dietary supplement manufacturers list certain details about their products on product labels. the general information required on the package includes the name of the product; the word supplement or a statement that the product is a supplement; the quantity of the package contents; the name and location of the manufacturer, packer, or distributor; and directions for using the product. in addition to the general information, a supplement must also have what is called a Supplement Facts Panel. (must include information on serving size and amount of product per serving (by weight), the percent of Daily Value (%DV) that a particular ingredient or nutrient provides per serving (if this is known) and a list of the product’s dietary ingredients.
if a dietary ingredient is a botanical, the panel must list the scientific name of the plant or the common name that has been standardized in the reference book Herbs of Commerce (2000 edition). the panel must also include the name of the plant part that has been used,
if the dietary ingredient in supplements is a proprietary blend, meaning a blend that is exclusive to the manufacturer, the supplement facts panel must list the total weight and its components in descending order of predominance by weight
botanicals; a plant of plant part valued for its health-promoting properties, flavor, and/or scent. Herbs are a subset of botanicals.
dietary ingredients without daily values are listed next (after the name and amounts of dietary ingredients with Daily Values). for botanical ingredients, either the standard common name or the science name of the plant must be provided. this label provides both names.
supplements must also include another ingredients panel. this list all non dietary components found in the product, such as fillers, water, artificial colors, sweeteners, flavors, and processing aids such as binders, gelatin, and stabilizers. these ingredients are listed by [..] name or proprietary blend in [..] order of predominance by weight. the ingredients listed in this panel may include the sources of the dietary ingredients if they are not identified on the supplement facts panel - for instance, a label might list rose hips as the source of vitamin C
common, descending
dietary supplement labeling requirements; must also include the name of product and identify as a dietary supplement. contact info (domestic [..] or [..] number (for consumers to report adverse effects), and structure/functions claims are allowed on supplement labels, but they must be accompanied by the disclaimer ->
address, telephone
“these statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease”
finally, supplement labels may also contain cautionary statements about potential side effects, but if a supplement does not have a cautionary statement, it does not mean that the product is [..] safe. unlike conventional drugs, supplement manufacturers do not have to list known adverse effects on their labels.
completely
supplement labels can also include health claims that describe a relationship between a dietary ingredient and [..] risk of a disease or condition. the FDA must reapprove these claims based on Significant Scientific Agreement (SSA) about the publicly available scientific evidence.
reduced
e.g. A supplement containing calcium and vitamin D can legally claim that it reduces the risk of osteoporosis, for instance, and a folic acid supplement can say that it may prevent fetal neural tube defects
the FDA also allows the use of qualified health claims for conventional foods and dietary supplements when the evidence linking a food, food component, or supplement to a reduced risk of a disease is emerging but not well enough established to meet the SSA standard for a true health claim. Qualifying language is included to indicate that the evidence supporting the relationship is limited - for instance you might read on a label that “supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease” But even qualified claims must be approved by the FDA based on the quality and strength of the scientific evidence
e.g. the number of studies demonstrating a beneficial effect may be limited, or the results of studies may be inconsistent.
selected approved health claims, FDA, nutrient and disease;
calcium and osteoporosis
adequate calcium throughout life, as part of a well balanced diet, may reduce the risk of osteoporosis
selected approved health claims, FDA, nutrient and disease;
dietary fat and cancer
development of cancer depends on many factors. a diet low in total fat reduce the risk of some cancers.
selected approved health claims, FDA, nutrient and disease;
sodium and hypertension
diets low in sodium may reduce the risk of high blood pressure, a disease associated with many factors
selected approved health claims, FDA, nutrient and disease;
dietary saturated fat and cholesterol and risk of coronary heart disease
although many factors affect heart disease, diets low in saturated fat and cholesterol may reduce the risk of this disease
selected approved health claims, FDA, nutrient and disease;
fiber containing grain products, fruits, and vegetables and cancer
low fat diets rich fiber containing grain products, fruits, and vegetables may reduce the risk of some types of cancer, a disease associated with many factors
selected approved health claims, FDA, nutrient and disease;
fruits, vegetables, and grain products that contain fiber, particularly soluble fiber, and risk of coronary heart disease
diets low in saturated fat and cholesterol and rich in fruits, vegetables, and grain products that contain some types of dietary fiber, particularly soluble fiber, may reduce the risk of heart disease, a disease associated with many factors
selected approved health claims, FDA, nutrient and disease;
folate and neural tube defects
healthful diets with adequate folate may reduce a woman’s risk of having a child with a brain or spinal cord defect
selected approved health claims, FDA, nutrient and disease;
potassium and the risk of high blood pressure and stroke
diets containing foods that are a good source of potassium and are low in sodium may reduce the risk of high blood pressure and stroke
selected approved health claims, FDA, nutrient and disease;
whole grain foods and risk of heart disease and certain cancers
diets rich in whole grain foods and other plant foods and low in total fat, saturated fat, and cholesterol may reduce the risk of heart disease and some cancers
selected Qualified health claims, FDA, nutrient and disease;
green tea and cancer
eligible foods; green tea and conventional foods and dietary supplements that contain green tea
claim statement; green tea may reduce the risk of breast or prostate cancer. the FDA has concluded that there is very little scientific evidence for this claim
selected Qualified health claims, FDA, nutrient and disease;
selenium and cancer
eligible foods; dietary supplements containing selenium
claim statement; selenium may produce anti-carcinogenic effects in the body. some scientific evidence suggests that consumption of selenium may produce anti-carcinogenic effects in the body. however, the FDA has determined that this evidence is limited and not conclusive
selected Qualified health claims, FDA, nutrient and disease;
antioxidant vitamins and cancer
eligible foods; dietary supplements containing vitamin E and/or vitamin C
claim statement; vitamin C may reduce the risk of gastric cancer. The FDA has concluded that there is very little scientific evidence for this claim. vitamin E may reduce the risk of colorectal cancer. the FDA has concluded that there is very little scientific evidence of this claim
selected Qualified health claims, FDA, nutrient and disease;
omega-3 Fatty acids and coronary heart disease
eligible foods; conventional foods and dietary supplements that contain EPA and DHA omega-3 fatty acids
claim statement; supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease
supplement manufacturers can’t make claims that their product [..], [..], or [..] disease unless it has been approved for a health claim or qualified health claim. however, companies can make a structure/function claim on the label about how that product could affect the body’s structure or function. due to the claims that consuming a nutrient or dietary ingredient may improve general well being or describe a benefit related to a nutrient deficiency disease, labels containing these claims must state in a disclaimer that the FDA has not evaluated the aim and that the product tis not intended to diagnose, treat, cure, or prevent any disease.
treats, prevents, or cures
e.g. “calcium builds strong bones” is a structure related claim,
whereas
“fiber maintains bowel regularity” or “antioxidants maintain cell integrity” are function related claims.
still, “more times than not, the label is going to be [..], and the claims are going to be overly [..]”
misleading ,
positive
does the FDA monitor supplements of quality assurance, potency, purity, or efficacy (effectiveness)
no,
there are far too many supplements of the agency to handle - but the FDA does track reports of illness, injury, or reactions that might occur in consumers who have take supplements.
supplement manufacturers are now required to report serious harmful effects to FDA
yes
if supplements are labeled as
“pure,” “natural,” or “quality-assured” but because the FDA does not regulate these terms, these claims may be [..] . supplements that claim to be “all natural,” for instance, are not always better or safer than refined or synthetic substances, because natural and synthetic forms generally have the same chemical structure and do not differ in terms of how they are absorbed or used by the body. They may, however, differ in price - the “natural forms are often costlier”
false, not true
ways customers can gauge supplement quality;
independent labs test supplements that manufactures voluntarily submit; some labs also do product reviews. organizations such as the United States pharmacopeial convention (USP) - a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements distributed and consumed worldwide - provide seals of quality that companies can display on their products. another independent lab that provides quality labels is NSF international (NSF)
The National Cancer Institute studies led by Omenn and his colleagues suggest that some supplements not only are [..] but also can be [..]. a small subset of studies, however, suggests that supplements may be [.] for preventing certain conditions
ineffective
harmful, beneficial
the combination of many vitamins at [..] doses made a positive difference
lower
no laws establish or cap potency for any supplements except potassium because of potential side effects on heart rate and rhythm. but high doses of some supplements can cause fatigue, diarrhea, hair loss, kidney stones, liver, and nerve damage, and birth defects. they can lead to nutrient imbalances or wanted interactions, reducing the absorption and utilization of other nutrients.
taking high doses of many minerals - as well as the [..] soluble vitamins A, D, and E - can be toxic. even high doses of the [..] soluble vitamin B6 are toxic, potentially causing permanent nerve damage.
fat
water
its important ro remember the even if you don’t exceed the UL for a nutrient through supplement use, you may exceed it when you combine the amount you’re getting from a supplement with the amount you’re getting from [..].
food
tips for choosing a multivitamin supplement ;
read the label carefully, look for quality products, look for expiration date, consider formulas for men, women and age groups, and don’t overdo it
special caveats; beware of interactions, some supplements may interfere with surgeries
- label; which nutrients are included, and amounts contained with each serving. choose a supplement that provides 100% of the DV for most of the vitamins and minerals in that supplement. (calcium and magnesium, are rarely included at 100% because the pill would be too large to swallow
- quality; USP, NSF . testers
- expiration; have long shelf life
gender, age groups; choose multivitamin designed for your age and so it’ll be right for you - don’t overdo; avoid that exceed 100% of daily recommended values
- beware, interactions; combination of supplements with medications could produce adverse effects.
- beware, surgery; before elective surgery you might have to stop taking vitamins, minerals, or supplemts to avoid potentially dangerous supplement/drug interactions 0 such as changes in heart rate, blood pressure, increased bleeding - could affect outcome of surgery
Botanical supplements are valued for their [..] or [..] properties to treat disease or maintain health.
medicinal
therapeutic
herbal supplements are a subset of botanicals that are typically [..] preparations of flowers, leaves, roots, bark, or seeds. are less popular in the US than vitamin and mineral supplements, but more than one fifth of US adults take them
dried
Botanicals include any supplement that is derived from [..] and may include liquid extracts, oils, or herbs.
plants
There are 550 primary herbs with 1800 names, but examples of some of the most common herbs sold in this country include echinacea, flaxseed, ginseng, ginkgo, saw palmetto, St. John’s wort, black cohosh, milk thistle, and garlic.
From a medicinal perspective, herbs are less potent crude [..] and can have [..] effects, yet they do not undergo the same stringent approval process as drugs do. Sometimes herbal supplements can contain biologically active ingredients and toxins in addition to their active “useful” components
drugs, drug like
Even though herbal supplements are often considered natural, they can still cause drug interactions and serious adverse effects and even exacerbate medical conditions; there is no legal definition for the term natural, and it certainly does not mean that a product is [..] or [..].
safe
effective
Athletes should be particularly cautious when contemplating the use of any sports-enhancing dietary supplement as they are often contaminated, intentionally or through poor manufacturing processes, with banned substances that can result in disqualification or adverse effects.
possible adverse effects and benefits associated with the use of herbal supplements;
Senna
possible benefits; laxative
adverse effects; liver failure with excessively high doses
possible adverse effects and benefits associated with the use of herbal supplements;
licorice root
possible benefits; protection against liver damage, anti-ulcer effects
adverse effects ; hypertension
possible adverse effects and benefits associated with the use of herbal supplements;
hawthorn
possible benefits; cardiovascular benefits
adverse effects; none
possible adverse effects and benefits associated with the use of herbal supplements;
ginger
possible benefits; reduction of nausea and vomiting
adverse effects; none
possible adverse effects and benefits associated with the use of herbal supplements;
garlic
possible benefits; reduction of hypertension and cardiovascular benefits
adverse effects; decreased clotting
possible adverse effects and benefits associated with the use of herbal supplements;
block cohosh
possible benefits; relief of menopausal symptoms
adverse effects; possible liver injury with long term use
possible adverse effects and benefits associated with the use of herbal supplements;
holy basil
possible benefits; anti-inflammatory, anti carcinogenic effects
adverse effects; none
possible adverse effects and benefits associated with the use of herbal supplements;
fenugreek
possible benefits; lower blood glucose and improved insulin sensitivity
adverse effects; diarrhea, low blood glucose
possible adverse effects and benefits associated with the use of herbal supplements;
St. John’s wort
possible benefits; treatment of mild to moderate depression
adverse effects; hypertension
possible adverse effects and benefits associated with the use of herbal supplements;
French Maritime Pine Bark (Pycnogenol)
possible benefits; antioxidant, decreased hypertension, improved cardiovascular function
adverse effects; may cause mild dizziness, nausea, headache
Food manufacturers may opt to [..] other nutrients to food products to boost nutritional value and potential health benefits. These products fall under a class of foods called functional foods (also called nutraceuticals). A functional food contains nutrients or other constituents, such as phytochemicals, that may enhance a food’s contribution to health and disease prevention beyond its basic nutritional content.
add
Functional foods may be whole foods or processed foods that have been touted to decrease the risk of cancer, heart disease, diabetes, or obesity or to slow the aging process. Some of these claims may be overhyped, but some may be valid.
yes
Functional foods include whole foods such as vegetables, whole grains, and berries that may provide health benefits due to the abundance of [..] they contain. Functional foods are also those foods that have been fortified with nutrients not traditionally found in the food, such as the addition of calcium to orange juice and the fortification of breakfast cereals with higher levels of vitamins and minerals. They may also be “engineered foods,” such as sports bars and sports drinks, that are designed to help you exercise longer or play sports more intensely.
phytochemical
In its 2013 position statement on functional foods, the Academy of Nutrition and Dietetics noted that “all food is essentially functional at some level, as it provides [..] and [..] needed to sustain life. However, there is growing evidence that some food components, not considered nutrients in the traditional sense, may provide [..] health benefits.”
energy, nutrients
positive
functional foods;
- orange juice has added calcium to improve [..] health
- blueberries and blackberries contain high amounts of anthyocyanins that promote [..] health
- yogurt has live bacterial cultures to promote [..] health
- margarine has plant sterols added to lower blood [..]
- tomatoes are naturally excellent source of the phytochemcials lutein and lycopene that are associated with a reduced risk of [..] disease and some [..], respectively
bone
cardiovascular, GI, cholesterol,
eye ,cancers
Nutrient-dense plant-based functional foods may, for instance, contain disease-fighting phytochemicals, or phytonutrients, which are biologically active constituents in foods. More than 2000 phytochemicals have been found in plant-based foods, and many have [..] or [..] actions and may help to reduce the risk of certain types of cancer and other chronic diseases.
antioxidant
hormone like
Functional foods also might contain prebiotics, which are [..] carbohydrates broken down by bacteria in the large intestine, or probiotics, which are live beneficial microorganisms found in [..] foods. Prebiotics foster the [..] of healthy bacteria in the gut. Probiotics, when consumed in sufficient amounts, may confer gastrointestinal and other health benefits
nondigestible
fermented
growth