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Weight Loss Supplements

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Weight Loss Supplements The Good, The Bad, The Ugly Thad J. Barkdull, MAJ, MC Fellow, Sports Medicine Tri-Services National Capital Consortium Fellowship – PowerPoint PPT presentation

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Title: Weight Loss Supplements


1
Weight Loss SupplementsThe Good, The Bad, The
Ugly
  • Thad J. Barkdull, MAJ, MC
  • Fellow, Sports Medicine
  • Tri-Services National Capital Consortium
    Fellowship
  • Fort Belvoir, Virginia

Adapted from presentation by Rodney Gonzalez, MD
2
Outline
  • Obesity Biostatistics
  • General Supplement Information
  • DSHEA of 1994
  • Specific Weight Loss Supplements
  • Summary of Recommendations

3
Obesity
  • Obesity in America (2000)
  • Estimated 30.5 of adults were obese (BMI gt 30)
  • Estimated 15.5 of adolescents overweight (BMI
    20-30)

4
Obesity
from www.obesityinamerica.org a website for The
Endocrine Society and The Hormone Foundation
5
Obesity
from www.obesityinamerica.org a website for The
Endocrine Society and The Hormone Foundation
6
Obesity
from www.obesityinamerica.org a website for The
Endocrine Society and The Hormone Foundation
7
Obesity
from www.obesityinamerica.org a website for The
Endocrine Society and The Hormone Foundation
8
Obesity
from www.obesityinamerica.org a website for The
Endocrine Society and The Hormone Foundation
9
Obesity
  • Federal Trade Commission, Sep 2002
  • U.S. Surgeon General said that overweight and
    obesity afflicted 6 out of every 10 Americans
  • Second leading cause of preventable death (after
    smoking) 300,000 deaths/yr
  • Costs Direct/indirect estimated to exceed 100
    BILLION/year

10
Supplements
  • In 2001, one study showed 53 of American adults
    use vitamins, supplements or minerals
  • Survey in 1998 found
  • 7 of adults have used OTC weight-loss
    supplements
  • Greatest percentage in young, obese women (28)

11
Supplements
  • In 2000, consumers spent 34.7 billion on weight
    loss products and programs
  • In 2001, weight loss supplements had retail sales
    estimated at 1.3 BILLION
  • Metabolife 356 (ephedra containing) was the top
    selling at 70 million, increase of 127 over
    2000 sales

12
Supplements
Dietary Supplement Establishments
from Dietary Supplement Strategic Plan Cost Out
(Report to Congress) by the US FDA, Center for
Food Safety and Applied Nutrition, May 29, 2002.
13
Supplements
Dietary Supplement Sales (1994 to 2000)
from Dietary Supplement Strategic Plan Cost Out
(Report to Congress) by the US FDA, Center for
Food Safety and Applied Nutrition, May 29, 2002.
14
Supplements
Dietary Supplement Estimated Sales Breakdown
from Dietary Supplement Strategic Plan Cost Out
(Report to Congress) by the US FDA, Center for
Food Safety and Applied Nutrition, May 29, 2002.
15
Supplements
  • In 2005, retail sales within the U.S. consumer
    packaged goods health and wellness industry
    reached 79 billion
  • Functional/Fortified Foods Beverages
  • 29.4 billion (26 growth)Vitamins, Minerals,
    Herbal Dietary Supplements
  • 19.6 billion (3 growth)Organic
    Foods/Beverages
  • 12.8 billion (17 growth)Natural
    Foods/Beverages
  • 12.4 billion (11 growthNatural/Organic
    Personal Care
  • 4.9 billion (22 growth)

from Natural Marketing Institute, Feb 28, 2006.
16
Supplements
  • Marketed as natural
  • May be interpreted as being safe and efficacious
  • Adoption of good manufacturing practices by
    supplement makers is not mandatory
  • Quality (absence of contamination and accuracy of
    labeling) may be variable and uncertain

17
From www.natureshealthypeople.com
  • Dieters Cleanse is a 14-day cleanse program.
    Weight Loss. Proper cleansing of the digestive
    tract allows for better elimination of waste and
    improved absorption of nutrients from the food
    you eat.
  • Bowel Detox provides key nutrients for digestive
    and intestinal systemic function and
    balance.Master Gland Formula strengthens the
    glands throughout the body that produce hormones
    essential for total body health. Hormones
    influence balance and harmony in all body
    systems.
  • Enviro-Detox helps cleanse the daily accumulation
    of toxins from the body and is designed to
    provide ongoing support to the bodys natural
    cleansing functions.

Liver Cleanse Formula nourishes and strengthens
the liver, the primary organ for filtering toxic
waste. LBS II supports the production of
digestive enzymes and bile to promote healthy
colonic bacteria. GTF Chromium processed foods
have little or no chromium without chromium
cells resist insulin and do not absorb the
glucose necessary for energy. The liver also uses
chromium to manufacture fatty acids, lecithin,
cholesterol, and lipoproteins. SF (Vital
Nutrition, Weight Management) supports the body
with adaptogenic herbs for balance. Designed to
support the bodys weight-management mechanisms,
with added benefits for the Urinary and Digestive
Systems. Higher quantities of nutrients are
required during balancing required for weight
management.
18
  • IngredientsBOWEL DETOXVitamin A
    (beta-carotene) 534 IUVitamin C (ascorbic acid)
    20 mg
  • Vitamin E (d-alpha tocopherol) 4 IU Zinc
    (gluconate) 2 mg Selenium (amino acid chelate)
    10.6 mcgBetaine HCl 16 mgBile Salts 16 mg
  • Pancreatin 72 mgPepsin 16 mg
  • Other Ingredients Psyllium hulls (Plantago
    ovata), Algin (from brown seaweed), Cascara
    Sagrada bark (Rhamnus purshiana), Bentonite clay,
    Apple pectin, Marshmallow root (Althaea
    officinalis), Parthenium root (Parthenium
    integrifolium), Charcoal, Ginger rhizome
    (Zingiber officinale), Sodium copper
    chlorophyllin, gelatin, and water.

19
  • MASTER GLAND FORMULA Vitamin A (beta-carotene)
    900 IU Vitamin C (ascorbic acid) 60 mg Vitamin
    E (d-alpha tocopherol) 14 IU Pantothenic Acid
    (d-calcium pantothenate) 24 mg
  • Zinc (gluconate) 6 mg
  • Manganese (amino acid chelate) 1 mg Potassium
    (citrate) 20 mg
  • Lecithin 25 mg
  • Other Ingredients
  • Licorice root (Glycyrrhiza glabra), Alfalfa
    aerial parts (Medicago sativa), Asparagus stem
    (Asparagus officinalis), Black Walnut hulls
    (Juglans nigra), Kelp leaves and stem
    (Ascophyllum nodosum and Laminaria digitata),
    Parsley leaves (Petroselinum crispum), Parthenium
    root (Parthenium integrifolium), Thyme herb
    (Thymus vulgaris), Asparagus stem (Asparagus
    officinalis), Dandelion root (Taraxacum
    officinale), Dong Quai root (Angelica
    polymorpha), Lemon bioflavonoids, Schizandra
    fruit (Schisandra chinensis), Eleuthero root
    (Eleutherococcus senticosus), Marshmallow root
    (Althaea officinalis), Uva Ursi leaf
    (Arctostaphylos uva ursi) gelatin, and water.

20
  • ENVIRO-DETOX
  • Proprietary blend 501 mg
  • Burdock Root (Arctium lappa)Dandelion Root
    (Taraxacum officinale)Fenugreek Seed (Trigonella
    foenum-graecum)Ginger Rhizome (Zingiber
    officinale)Marshmallow Root (Althaea
    officinalis)PepsinRed Clover Flowers (Trifolium
    pratense)Sarsaparilla Root (Smilax
    officinalis)Yellow Dock Root (Rumex
    crispus)Echinacea Root (Echinacea
    purpurea)Lactospores (Lactobacillus
    sporogenes)Cascara Sagrada Bark (Rhamnus
    purshiana)Milk Thistle Seed Concentrate (Silybum
    marianum)
  • LIVER CLEANSE FORMULAAmount Per
    CapsuleProprietary blend 450 mg
  • Red Beet Root (Beta vulgaris)Dandelion Root
    (Taraxacum officinale)Parsley Leaves
    (Petroselinum crispum)Horsetail Stems and
    Strobilus (Equisetum arvense)Yellow Dock Root
    (Rumex crispus)Black Cohosh Root (Cimicifuga
    racemosa)Birch Leaves (Betula pendula)Blessed
    Thistle Aerial Parts (Cnicus benedictus)Angelica
    Root (Angelica archangelica)Chamomile Flowers
    (Matricaria recutita)Gentian Root (Gentiana
    lutea)Golden Rod Aerial Parts (Solidago
    virgaurea)LBS II Amount Per 3
    CapsulesProprietary blend 1,275 mg
  • Cascara Sagrada Bark (Rhamnus purshiana)Buckthor
    n Bark (Rhamnus frangula)Licorice Root
    (Glycyrrhiza glabra)Capsicum Fruit (Capsicum
    annuum)Ginger Rhizome (Zingiber
    officinale)Oregon Grape Root (Berberis
    aquifolium)Turkey Rhubarb Root (Rheum
    officinale)Couch Grass Rhizome (Agropyron
    repens)Red Clover Tops (Trifolium pratense)

21
  • SFProprietary blend 900 mgChickweed Aerial
    Parts (Stellaria media)Cascara Sagrada Bark
    (Rhamnus purshiana)Licorice Root (Glycyrrhiza
    glabra)Safflower Flowers (Carthamus
    tinctorius)Black Walnut Hulls (Juglans
    nigra)Parthenium Root (Parthenium
    integrifolium)Gotu Kola Aerial Parts
    (Hydrocotyle asiatica)Hawthorn Berries
    (Crataegus oxyacantha)Papaya Fruit (Carica
    papaya)Fennel Seed (Foeniculum
    vulgare)Dandelion Root (Taraxacum officinale)
  • GTF CHROMIUM Chromium (chromium amino acid
    chelate,chromium nicotinate) 500 mcg Proprietary
    blend 472 mg
  • Alfalfa Aerial Parts (Medicago sativa)Horsetail
    Stems and Strobilus (Equisetum arvense) Red
    Clover Flowers (Trifolium pratense) Yarrow
    Flower (Achillea millefolium) Other Ingredients
    Magnesium stearate (vegetable), gelatin, and
    water.

22
Dietary Supplement Health Education Act
-1994DSHEA
23
DSHEA of 1994
  • Congressional Intent
  • Limit impediments to marketing and promoting
    dietary supplements
  • Provide a wide availability of supplements to the
    consumer
  • Enhance information available to the consumers

24
DSHEA of 1994
  • Defined dietary supplements
  • Provisions for safety, marketing and good
    manufacturing practices
  • Provisions for ingredient and nutrient labeling
  • Provisions for use of health claims

25
DSHEA of 1994
  • Definitions of a supplement
  • a product (other than tobacco) intended to
    supplement the diet that bears or contains one or
    more of the following dietary ingredients 21
    U.S.C. 321(ff)(1)

vitamin
mineral
herb or other botanical
amino acid
a dietary substance for use by man to
supplement the diet by increasing the total intake
a concentrate, metabolite, constituent, extract
or combination of any ingredient described above
26
DSHEA of 1994
  • Safe, unless proven unsafe by FDA
  • Not required to show bioequivalence
  • Can state that a product does something
    beneficial, but cannot make a medical claim
  • Must also have
  • This statement has not been evaluated by the
    Food and Drug Administration. This product is
    not intended to diagnose, treat, cure, or prevent
    any disease.

27
Label Requirements
from www.cfsan.fda.gov/acrobat/fdsuppla.pdf
28
DSHEA of 1994
  • Congressional Intent
  • Limit impediments to marketing and promoting
    dietary supplements
  • Provide a wide availability of supplements to the
    consumer
  • Enhance information available to the consumers

29
DSHEA of 1994
  • Manufacturers Application
  • Allow them to formulate and release supplements
    without research
  • Provide many different supplement types and
    combinations without research
  • Tell consumers what they want them to know about
    a product


30
Weight Loss Supplements
  • FTC Sep 2002 Reports
  • Nearly 40 of sampled adds made at least one
    representation that almost certainly is false
  • 55 of the ads made at least one representation
    that is very likely to be false or lacks adequate
    substantiation
  • Between 1992 and 2001, frequency of weight loss
    advertisements in magazines doubled
  • Type of advertisement sifted from meal
    replacement in 1992 (57) to dietary supplements
    (66) in 2001

31
Weight Loss Supplements
  • People do not want to make lifestyle changes.
    They are looking for the quick fix.

32
Weight Loss Supplements
  • Google weight loss supplements
  • 54,800,000
  • MD Consult weight loss supplements
  • 1,378 Journals/MEDLINE
  • 1 Reference Book
  • 17 Current Practice
  • 41 Practice Guidelines
  • 139 Patient Handouts

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33
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Weight Loss Supplements
Eating good all the time just isnt fun or
practical!
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Cheaters Relief will help you keep your shape,
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from www.supplements101.com
36
Weight Loss Supplements
  • Should ask a patient about supplements
  • Have you tried, or considered trying, special
    diets, exercise programs, diet pills, herbs, or
    vitamins for weight loss?
  • Do you take any over the counter medications,
    including vitamins and supplements?

37
Weight Loss Supplements
  • Increase energy expenditure
  • Modulate carbohydrate metabolism
  • Increase satiety
  • Increase fat oxidation or reduce fat synthesis
  • Block dietary fat absorption
  • Increase water elimination
  • Enhance mood
  • Other miscellaneous or unspecified

38
Weight Loss Supplements
Ephedra Alkaloids and Caffeine Compounds
  • Increase energy expenditure
  • Ephedra
  • Bitter orange
  • Guarana
  • Caffeine
  • Country mallow
  • Yerba Maté

39
Weight Loss Supplements
Ephedra Alkaloids and Caffeine Compounds
  • Shekelle, et al. reported in 2003 a meta-analysis
    of RCTs showing ephedra had a weight loss of 2lb
    more per month compared to placebo
  • However, they also showed they had a 2.2 to
    3.6-fold increase in adverse events (psychiatric,
    autonomic, cardiovascular and gastrointestinal
    symptoms)

40
Weight Loss Supplements
Ephedra Alkaloids and Caffeine Compounds
  • FDA MedWatch
  • 87 reports of ephedra adverse events between June
    97 and March 99
  • HTN, arrhythmias, MI, stroke and seizures
  • 10 events led to death
  • 13 others yielded permanent disability
  • 9 of the 23 were at the recommended doses in
    individuals without cardiovascular risk factors

41
Weight Loss Supplements
Ephedra Alkaloids and Caffeine Compounds
  • Ephedra comprised 0.8 of dietary supplement
    sales in 2001
  • However, in 2001, they were responsible for 64
    of all herb-related adverse events reported to
    the U.S. Poison Control Centers
  • Bitter orange and country mallow and other
    ephedra-like substances are in the Ephdra-free
    weight loss supplements

42
Weight Loss Supplements
Ephedra Alkaloids and Caffeine Compounds
  • Some products, especially those containing
    stimulants, can cause short-term weight loss.
    (Likewise, amputation of an extremity can cause
    weight loss.) But the risk outweighs the
    benefit.
  • - Scott GN, et al. Problems with Weight Loss
    Products. Pharmacists Letter/Prescribers
    Letter 2006221-3.

43
Weight Loss Supplements
Ephedra Alkaloids and Caffeine Compounds
  • The Good
  • They work
  • The Bad
  • They have many adverse events
  • The Ugly
  • They can kill
  • Ephedra sales banned by the FDA in April 2004

44
Ephedra Ban Ruled Invalid
  • Ephedra Diet PillsOn April 13, 2005 the 2004
    Final Rule issued by the FDA banning Ephedra was
    overturned by a Federal Judge (Case No. 204CV409
    TC).  An appeal was filed on June 13, 2005
    however it will take some time for this case to
    be decided.

45
Weight Loss Supplements
Chromium and Ginseng
  • Modulate carbohydrate metabolism
  • Chromium
  • Ginseng

46
Weight Loss Supplements
Chromium and Ginseng
  • Chromium is thought to play a role in
    carbohydrate and lipid metabolism
  • Chromium deficiency is associated with
    hyperglycemia, hyper-insulinemia,
    hypertriglyceridemia and low HDL
  • Three (small) RCTs of chromium supplements showed
    no difference in weight loss when compared to
    placebo

47
Weight Loss Supplements
Chromium and Ginseng
  • No adverse events at recommended dose of
    chromium, but rhabdomyolysis and renal failure
    have been reported at super-therapeutic doses
    (1000mcg vs 200 to 400mcg)

48
Weight Loss Supplements
Chromium and Ginseng
  • Ginseng has preliminary data suggesting that it
    may improve glucose tolerance
  • No RCTs in humans have shown greater weight loss
    with ginseng when compared to placebo

49
Weight Loss Supplements
Chromium and Ginseng
  • The Good
  • They may be safe
  • The Bad
  • No good RCTs to show efficacy
  • The Ugly
  • Potential renal failure

50
Weight Loss Supplements
Glucomannan, Psyllium, and Guar Gum
  • Increases satiety
  • Guar gum
  • Glucomannan
  • Psyllium

51
Weight Loss Supplements
Glucomannan, Psyllium, and Guar Gum
  • Action soluble fiber that absorbs water within
    the gut causing a fullness sensation
  • May improve control of diabetes and
    hyperlipidemia (fiber affect)

52
Weight Loss Supplements
Glucomannan, Psyllium, and Guar Gum
  • Glucomannan 3 (small) RCTs showed dosages of 3
    to 4g per day were tolerated and yielded modest
    weight loss
  • Psyllium Showed no difference in weight loss in
    patients with Type 2 Diabetes (but did improve
    glucose and lipid parameters)
  • Guar gum 11 RCTs showed no benefit over placebo

53
Weight Loss Supplements
Glucomannan, Psyllium, and Guar Gum
  • The Good
  • They may be safe
  • The Bad
  • No good RCTs to show efficacy, save modest weight
    loss with Glucomannan
  • The Ugly

54
Weight Loss Supplements
Act on Fat Oxidation or Synthesis
  • Increase fat oxidation or reduce fat synthesis
  • L-carnitine
  • Hydroxycitric acid
  • Green tea
  • Vitamin B5
  • Licorice
  • Conjugated linoleic acid
  • Pyruvate

55
Weight Loss Supplements
Act on Fat Oxidation or Synthesis
  • Hydroxycitric Acid
  • Inhibits mitochondrial citrate lyase, leading to
    decreased acetyl coenzyme A production and
    decreased fatty acid synthesis
  • 12-week RCT of mildly overweight women showed
    nearly 3 lb weight loss at 750mg
  • However, a larger study of men and women showed
    no difference at 1,500mg dose

56
Weight Loss Supplements
Act on Fat Oxidation or Synthesis
  • Conjugated linoleic acid
  • In mice, reduces fat deposition postulated to be
    through increased fat oxidation and decreased
    triglyceride uptake in adipose tissue
  • 12-week RCT of 3.4 to 6.8 g/day showed no change
    in BMI and mild to moderate GI symptoms
  • May increase insulin resistance

57
Weight Loss Supplements
Act on Fat Oxidation or Synthesis
  • Green tea in one study increased fat oxidation
    and thermogenesis however, study not designed to
    assess weight loss
  • Licorice reduced body fat mass without change
    BMI however, shown to also have adverse outcomes
    of pseudoaldosteronism, hypertension and
    hypokalemia

58
Weight Loss Supplements
Act on Fat Oxidation or Synthesis
  • Pyruvate at 6g per day had a 2 lb 10oz weight
    loss compared to placebo over six weeks
  • Vitamin B5 and L-carnitine have not had any trial
    to support claims of causing weight loss

59
Weight Loss Supplements
Act on Fat Oxidation or Synthesis
  • The Good
  • They may be safe
  • Pyruvate may have weight loss
  • The Bad
  • Minimal and sometimes conflicting data to support
    weight loss
  • The Ugly
  • Conjugated linoleic acid may increase insulin
    resistance

60
Weight Loss Supplements
Chitosan
  • Block dietary fat absorption
  • Chitosan

61
Weight Loss Supplements
Chitosan
  • Blocks fat absorption by binding to negatively
    charged fat molecules within the intestinal lumen
  • Five RCTs (all by the same investigators) showed
    effective weight loss
  • However, three other well-designed RCTs (by
    different investigators) showed no differences in
    weight loss
  • No proof of increased fecal fat excretion in
    healthy individuals taking Chitosan

62
Weight Loss Supplements
Chitosan
  • The Good
  • They appear be safe
  • The Bad
  • Some investigators show effectiveness in poorly
    designed studies
  • Should note be taken by those allergic to
    shellfish
  • The Ugly
  • Different investigators show no effect of
    Chitosan on weight loss

63
Weight Loss Supplements
Water Elimination
  • Increase water elimination
  • Dandelion
  • Cascara

64
Weight Loss Supplements
Water Elimination
  • Dandelion diuretic activity
  • Cascara laxative affect
  • Neither one studied for effectiveness in weight
    loss
  • Theoretically may have same adverse effects of
    long term use of diuretics and laxatives
    (dehydration and electrolyte abnormalities)

65
Weight Loss Supplements
Water Elimination
  • The Good
  • The Bad
  • No studies to show efficacy
  • May have adverse events similar to long-term
    diuretic and laxative usage
  • The Ugly

66
Weight Loss Supplements
Enhancement of Mood
  • Enhance mood
  • St. Johns wort

67
Weight Loss Supplements
Enhancement of Mood
  • St. Johns wort inhibits serotonin re-uptake
  • Increase of serotonin is believed to stimulate
    the hypothalamus and produce the feeling of
    fullness
  • No studies to show effectiveness in weight loss

68
Weight Loss Supplements
Enhancement of Mood
  • The Good
  • They may be safe
  • The Bad
  • No good RCTs to show efficacy
  • The Ugly

69
Weight Loss Supplements
Miscellaneous Other Supplements
  • Miscellaneous or unspecified
  • Laminaria
  • Spirulina (blue-green algae)
  • Guggul
  • Apple cider vinegar

70
Weight Loss Supplements
Miscellaneous Other Supplements
  • Spirulina contains phenylalanine, which is
    reported to inhibit appetite
  • However, in 1981, the FDA declared it to be
    ineffective for weight loss and no studies have
    since looked at it for weight loss
  • Other substances here have also never been
    studied for weight loss

71
Weight Loss Supplements
Enhancement of Mood
  • The Good
  • They may be safe
  • The Bad
  • No good RCTs to show efficacy
  • The Ugly
  • FDA already declared spirulina ineffective

72
Weight Loss Supplements
73
Weight Loss Supplements
Saper, RB, Phillips, RS. Common Dietary
Supplements for Weight Loss. Am FamPhysician
2004701731-1738.
74
Weight Loss Supplements
  • Increase energy expenditure
  • Modulate carbohydrate metabolism
  • Increase satiety
  • Increase fat oxidation or reduce fat synthesis
  • Block dietary fat absorption
  • Increase water elimination
  • Enhance mood
  • Other miscellaneous or unspecified

Healthy Diet and Exercise
75
Reporting Adverse Outcomes
  • FDA MedWatch (for Health Care Providers)
  • 1-800-FDA-1088
  • www.fda.gov/medwatch/report/hcp.htm
  • Consumers can report it to
  • 1-800-FDA-1088
  • www.fda.gov/medwatch/report/consumer/consumer.htm

76
Evidence-based Resources on Dietary Supplements
for Physicians
  • Natural Medicines Comprehensive Database
    (www.naturaldatabase.com)
  • Natural Standard (www.naturalstandard.com)
  • E-pocrates (www.epocrates.com)
  • ConsumerLab.com (www.consumerlab.com)
  • Fugh-Berman A. The five-minute herb dietary
    supplement consult. Philadelphia Lippincott
    Williams Wilkins, 2003.
  • Rotblatt M, Ziment I. Evidence-based herbal
    medicine. Philadelphia Lippincott Williams
    Wilkins, 2001.

77
Weight Loss Supplements
  • Weight Loss Products Some of these supplements
    promise to stop cravings and burn fat. Others
    claim to prevent fat and cholesterol absorption,
    permitting weight loss without changes to diet.
    There is no evidence supporting the products'
    effectiveness. "Effortless" weight loss remedies
    do not work and are directly tied to the public
    health concern about obesity.

from Dietary Supplement Enforcement Report by
the US FDA, December 18, 2002.
(www.fda.gov/oc/nutritioninitiative/report.html)
78
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