Evaluation of Dietary Supplements for Performance Nutrition - The ...

National Athletic Trainers’Association Position Statement:Evaluation of Dietary Supplements forPerformance NutritionKathleen M. Laquale, PhD, ATC, LAT, LDNProfessor and Licensed Dietary NutritionistBridgewater State Universityklaquale@bridgew.edu

The objectives of this position statement are tohelp the athletic trainer:

• The use of foods and dietary supplements toenhance health and athletic performance(ergogenics) has existed since the earlyOlympic Games.• Herbs, potions, bee pollen and oils were thesupplements of the day.

GENERAL MAXIMSFOR HEALTH• Rise early. Eat simple food. Take plenty ofexercise. Never fear a little fatigue.• Avoid the necessity of a physician if you can,by careful attention to your diet.• If you find yourself really ill, send for a goodphysician. Have nothing to do with quacks;and do not tamper with quack medicines. Youdo not know what they are; and what securityhave you that they know what they are!– The American Frugal Housewife by Mrs. Child - 1833

SNAKE OIL CURES-MARKETEDAS MIRACULOUS REMEDIES

Modern Snake Oil?Safety Issues: SupplementsSAFI BLOOD PURIFIER – Indian herbal product found in NJstores in May 2007Promoted for acne, boils, rashes, blemishesClaims to cure constipation, check nose bleeding, correctindigestion, improve complexionConfusing wording “builds sturdy babies” is actually an ad foranother productBUT…IT CONTAINS MORE THAN 40 TIMESTHE ALLOWABLE AMOUNT OF ARSENIC!!!

TODAYAthletes at all levels of competition are continually working to improveperformance, and many consider use of dietary supplements or engineeredfoods to gain an additional performance edge or health benefit

HE SAID –SHE SAID• Athletes may receive advice and feelpressure from many well-meaningsupporters and advocates.• However, they can be vulnerable tomisinformation and risk.• The overwhelming industry presenceand advertising appeal likely hasstrong influence on athlete choices.

What are Dietary Supplements?Micronutrientsvitamins & mineralsMacronutrientsfatty acids,protein, amino acidsHerbs (botanicals)echinacea, ginkgo,garlicPhytochemicalslycopene,isoflavonesZoochemicalscreatine, CLA, beepollenMiscellaneous itemsprobiotics,glucosamine,melatonin

Multibillion Dollar Industry 1994 = 8.3 billion 1999 = 14 billion 2009 = 22.8 billion 2010 = 23.7 billion 2012 = over 25 billion

Meal Supplements &Sports NutritionMeal Supplements: liquid“formulas created primarily tosubstitute, but sometimessupplement, a meal.” Includesenteral feeding products & weightloss products.Sports Nutrition: “pills, powders/formulas and drinks (excludingGatorade, Powerade, etc.)formulated to enhance physicalactivity...”

Other SupplementCriteriaIntended for ingestion in tablet,capsule, powder, softgel, gelcap, orliquid form.Ingested means “swallowed”(not sublinguals, nasal gels, etc.)It cannot resemble a food item

RECOMMENDATIONS• This position statement provides suggestionsfor resources to stay current among this everchanginglandscape of dietary supplements.• Evaluation of the literature associated withperformance nutrition and dietary supplementsresults in the following evidence-basedrecommendations:

The Role of the Athletic Trainerand Nutrition1. Proper nutrition and changes in the athlete’shabitual diet should be considered firstwhen attempting to improve performance.

COLUMNCOLUMN A gm gm gm COLUMN A COLUMNCOLUMN B gm gm gm COLUMN B A+B A AMOUNT P C F CALORIES B AMOUNT P C F CALORIES CALORIES PASTA (cooked) 1 C 8 43 1 221 TURKEY MEATBALLS 2 22 10 8 200 421 Banana 1 SMALL 1 19 0 72 YOGURT (nonfat) WHOLE 2 slices 4 20 2 92 CHICKEN WHEAT OVEN BREAD ROASTED WHITE MEAT 6 ounces 7 21 0 120 192 3 oz 15 3 6 108 200 PEANUT BUTTER 1 T CHOCOLATE MILK 1 Tbsp 8 7 16 94 GRAHAM CRACKERS 8 oz glass 8 26 8 208 TRAIL MIX REGULAR 3 3 15 1 80 174 (2 ½”squares) ¼ C 5 16 12 175 383 HARD BOILED EGGS 2 12 2 10 78 APPLE 1 0 25 0 95 173 APPLESAUCE unsweetened ½ C 0 25 0 97 SALTINE CRACKERS 5 1 10 1 56 153 WHOLE WHEAT BAGELS 1 3 14 0 71 FAT-­‐FREE CREAM CHEESE 2% milk 8 oz glass 8 12 0 83 FIG NEWTONS K. Laquale Advanced Magazine 20112 Tbs 5 2 0 30 101 2 oz 2 40 4 197 280

QUICK FIX FOOD PROVIDES QUICK FIX FOOD ALTERNATIVEMORNING WORKOUTRECOVERY FUELENERGY BARCARBOHYDRATES ANDPROTEINCEREAL AND MILKEVENING WORKOUTRECOVERY FUELPROTEIN BAR AND SPORTSDRINKCARBOHYDRATES ANDPROTEINPASTA AND MEATBALLSMORNING OR EVENINGRECOVERY FUELPROCESSED MILKPRODUCT FROM ASUPPLEMENTDISTRIBUTORCARBOHYDRATES ANDPROTEINCHOCOLATE MILK or WHOLE,1%, 2% or SKIM MILKBEVERAGESPORTS DRINKCARBOHYDRATESAND SODIUMHOMEMADE DRINK*IN A QUART BOTTLE:¼ CUP SUGAR DISSOLVED IN HOTWATER¼ CUP ORANGE JUICE¼ TEASPON OF SALT2 TABLESPOONS OF LEMONJUICE*Nancy Clark, RD, CSSDK. Laquale Advanced Magazine 2011

2. The athletic trainer should be knowledgeablein the area of performance nutrition, andshould be aware of resources for thisinformation.Nutrient Recommendations and general dietguidance: Dietary Reference Intakes (DRI) andRecommended Dietary Allowances (RDA):http://ods.od.nih.gov/health_information/Dietary_Reference_Intakes.aspx

SCAN• Sports, Cardiovascular and WellnessNutritionists practice group of AmericanDietetic Association:http://www.scandpg.org/ , factsheets athttp://www.scandpg.org/sports-nutrition/sports-nutrition-fact-sheets/

USDA MyPLATEhttp://www.choosemyplate.gov/Australian Institute of Sport:http://www.ausport.gov.au/ais/nutrition

RD LDN CSSD3. If not knowledgeable, the athletic trainershould establish a support team including aregistered dietitian or other nutrition relatedhealthcare professional.Registered Dietitian (RD)Licensed Dietary Nutritionist (LDN)Certified Sports Specialty Dietitian (CSSD)

REGULATIONConsumers need to understand the level ofregulation (or lack thereof) governing thesupplement industry at the international,federal, state and individual sportparticipation levels.

Dietary Supplements…• Look likedrugsRegulated morelike foods

WHAT IS THE PROBLEM WITHDIETARY SUPPLEMENTS?DIETARY SUPPLEMENTS ARE REGULATED BYTHE FEDERAL GOVERNMENT AS A CATEGORYOF FOOD-NOT AS A DRUG.MEDICATIONS ARE TESTED AND VERIFIED FORPOTENCY AND PURITY.WITH DIETARY SUPPLEMENTS, THERE IS NOTESTING STANDARD

Current laws on dietarysupplements: Dietary SupplementHealth and Education Act (DSHEA)• No requirement for efficacy(proof they do what they claim)• No requirement for safety(proof they cause no harm)

• The manufacturers and distributors of dietarysupplements are responsible for making suretheir products are safe BEFORE they go tomarket.• Manufacturers are required to produce dietarysupplements to minimum quality standards andensure that they do not contain contaminants orimpurities, and are accurately labeled.

Supplements Must Be Labeled As ADietary Supplement

1994 Dietary SupplementHealth and Education Act(DSHEA)• DSHEA places the burden of proof on the Foodand Drug Administration (FDA) to show that aproduct intended to supplement the diet creates anunreasonable risk of illness or injury, and shouldtherefore be prohibited.

ADVERSE EVENTS ORILLNESSES• Manufacturers are required to report allserious dietary supplement related adverseevents or illnesses to FDA as of December2007.

REPORTING ADVERSEEVENTS• Clinicians can report adverse events via the website http://vm.cfsan.fda.gov/~dms/supplmnt.htmlwhich is maintained by the FDA Center for FoodSafety and Applied Nutrition as a specialNutritional Adverse Events Monitoring System.• Adverse events can also be reported viaMedwatch, 1-800-FDA-1088 orwww.fda.gov/medwatch

EPHEDRA/ EPHEDRINE• FDA can take dietary supplements off the market if they arefound to be unsafe, adulterated, or if the claims on the productsare false and misleading.• A study of 16,000 adverse event reports found 2 deaths, 4 heartattacks and 9 strokes involving ephedra in which there were noother known contributing factors. Makers insist ephedra, astimulant, is safe when taken as directed.• This was demonstrated in 2004 when the FDA attempted toban ephedrine only to have the ban subsequently overturnedby a federal court, this is a difficult burden for the FDA tomeet.

Anabolic Steroid Control Act of 2004• Responding to criticism that arose after itwas revealed that some athletes (mostnotably baseball players) were using prohormonesthat were available in the UnitedStates over-the-counter, Congress enactedthe Anabolic Steroid Control Act of 2004.• This law, which took effect in January 2005,bans the sale of most steroid precursors suchas androstenedione.

WHAT SHOULD ANINFORMED CONSUMERKNOW?Supplement companies do not haveto provide the FDA with anyevidence that its supplements aresafe unless the company ismarketing a new dietary ingredientthat was not sold in the UnitedStates prior to 1994.

2004 FDA initiatives toimplement the DSHEA of 1994• Implement process to evaluatedietary supplements.• Set standards for consistency(GMPs) to ensure purity, quality,strength and exact composition.• Provide guidance on what claimscan be made.

ENTER THE GMPs -GOOD MANUFACTURINGPRACTICES• Consumer trust issues citing the December2007 press release by the FDA to join forceswith major trade organizations to “clean up”the industry• Be aware of deceptive claims such as “ExceedsGMP Standards” and “GMP Compliant” and“Food GMP.” These are self-declarations ofconformity to quality standards which do notrequire any third party testing.

Structure-Function ClaimCertain claims must have thefollowing disclaimer:“This statement has not been evaluated by theFood and Drug Administration. This product isnot intended to diagnose, treat, cure or preventany disease.”Without this statement on the labelit is an unapproved drug.No label is permitted to claim :“APPROVED BY THE FDA.”

Shakeology will help your body eliminateharmful toxins, decrease cholesterol levelsby about 30%, help you digest foods betterand improve bowel movement regularity –all while giving you accelerated weight lossresults and higher levels of energy.

Over 70+ ingredients Green Tea helpedwith weight loss(stated on website)• Over ten cups of tea/day to derive benefitsof weight loss• Studies did not demonstrate significancewhen weight loss was measured using greentea supplements• All studies on green tea which weight lossclaims are based were conducted on rats

WATCH OUT FORINGREDIENTS!No expirationdating is neededon the label ofdietarysupplements• INGREDIENTS ARE LISTED INDECENDING ORDER BY WEIGHT• AVOID “PROPRIETORY BLEND”• IF AN INGREDIENT IS LISTED ONTHE LABEL IT MAY NOT BE INTHE PRODUCT

SuperPump 250

SHAKEOLOGY• The meal replacement ingredient list includedSUMA ROOT (in very fine print)– a richsource of phytochemical compounds, includingECDYSTERONE.• ECDYSTERONE is a naturally occurringphytochemical compound that could beerroneously detected and flagged in syntheticsteroid screening tests.• The NFL and WADA added ECDYSTERONEto its list of banned substances in 2010

SO ARE SUPPLEMENTSREGULATED?• Without labeling evidence of third partyverification, there is no given level of truth inlabeling or non-contamination assumed whenpurchasing a product.• There is no burden of proof on amanufacturer to demonstrate productefficacy prior to marketing.

HOW CAN A CONSUMER KNOW IFTHE INGREDIENTS ARE ACTUALLYIN THE PRODUCT?Third Party Certification• Choose supplements with:– USP on the label– Consumer Lab seal of approvalhttp://www.consumerLab.com/seal.asp– Reputable drug companiesDon’t buy on the internet!

OTHER SYMBOLS –THIRDPARTY CERTIFICATIONNSF Certified for Sporthttp://nsf.org/business/athletic_banned_substances/index.asp?program=AthleticBanSubNSF/NFLPA – National Football League PlayersAssociationCertificationhttp://nsf.org/business/nfl_nflpa/index.asp?program=NFLPANational Sanitation Foundation - NSF

THIRD PARTYCERTIFICATIONCompanies which are certified are available athttp://www.nsf.org/certified/gmp/Listings.asp?ProgramProducts which are certified can be identifiedby performing a ‘Search’ atwww.nsf.org/certified/dietary.

ATHLETES CANNOT CLAIMIGNORANCE• Sport governing bodies provide athletes and sportpersonnel with governance regarding bannedsubstances and the adopted philosophy withregards to supplementation.• Athletic trainers should be prepared to educateathletes that dietary supplements are not wellregulated and may contain substances banned byvarious sport-governing bodies.

Banned Substances Control GroupAddresses the concern that dangerousbanned substances can be found in dietarysupplements, even when these substancesare not listed as ingredients.

BANNED SUBSTANCES• Labeling requirements for dietary supplements arenot consistent with controlled substances.• It is unrealistic to expect athletic trainers toperform a direct analysis of supplement purity.• Athletic trainers should be aware of resources tohelp identify companies or products known tohave a history of poor truth in labeling,adulteration or contamination.

Banned SupplementsIn 1889 Brown-Séquard, aged72, reported dramaticrejuvenating effects after selfadministeringtesticular extractsof dogs and guinea-pigs. Hisreport resulted in widespreaduse of testicular extractsthroughout Europe and NorthAmerica for several decades.Dr. Ziegler in 1950developedMethandrostenolone(Dianabol, Danabol) anorally-effective anabolicsteroid• IOC– 1968 1st list of bannedsubstances– 1976 Montreal Olympic Games– 1988 SEOUL Olympic Games

2012 WADA Banned Substance ListSubstances and Methods Prohibited at all times (both in- and out-of competition).• S1 - AAS– Nandrolone– Clenbuterol (asthma inother countries)• S2 - hormones and relatedsubstances– EPO, hGH, IGF-1, hCG,insulin, & corticotrophins– PRP given IM prohibited– PRP tendon injections -requires Declaration of Use– DM pts - need TherapeuticUse Exemption (TUE) forinsulin• S3 - Beta-2 Agonists -– Salbutamol (Ventolin,ProAir, DuoNeb)– Salmeterol (Advair,Serevent),– Others need TUE(terbutaline)– Oral use is prohibited• S4 - Agents with Anti-Estrogenic Activity– Aromatase inhibitors– SERMs - tamoxifen– Other Anti-Es -clomiphene

2012 WADA Banned Substance List• S5 - Diuretics and MaskingAgents• Masking Agents– Plasma Expanders -Albumin, Dextran, Glycerol(supplements banned)– Alpha-reductase inhibitors -Finasteride– Epitestosterone• Diuretics– Furosemide– SpironolactoneProhibited Methods• M1 - Enhancement of O2transfer– Blood doping, the use of redblood cells of any origin, orotherwise artificiallyenhancing the uptake ordelivery of oxygen remainsprohibited.• M2 - Chemical & PhysicalManipulation– Tampering– IV infusions (even if nonbannedsubstance unless inhospital setting)• M3 - Gene doping Thetransfer of cells or geneticelements, or the use ofagents that alter geneexpression is prohibited.

2012 WADA Banned Substance ListProhibited Substances IN Competition• S6 - stimulants– Pemoline, Prolintane• Ephedrine andmethylephedrine - U >10mcg/ml• Pseudophedrine - U >150mcg/ml (D/C >24hrsprior)• Athletes w/ ADD/ADHD– Need Theraputic UseExemption (TUE)• Not Prohibited– Caffeine• S7 - Narcotics– Fentanyl, Morphine• S8 - Cannabinoids• S9 -Glucocorticosteroids– PO, IV, PR, IM -(DOE/TUE)– Topical• P1 - ETOH• P2 - Beta-Blockers

1 M.R. by BPI SPORTS

CAFFEINE CONTENT• One Scoop (8 grams) of 1 M.R.= 300mg of caffeine• This is the equivalent to just under9 cans of Coca-Cola3 cans of Red Bull4 large cups of coffee• The recommended amount ofcaffeine a person should have in aday is 250-300 grams.• Above this level a person can start tofeel side effects such as:– Jitters– Headaches– nervousness– irritability– Insomnia– elevated heartbeat and blood pressure• Please keep in mind that caffeine isonly 2 of the 7 stimulants found in 1M.R.

1 M.R. contains Methylhexaneamine(MHA or 1,3 DMAA)• As a singular ingredient, MHA is the potential newephedrine (stimulant)• MHA is a vasoconstrictor and central nervous systemstimulant. Opponents argue it is an amphetamine-likeingredient that poses a serious health risk and haspotentially life-threatening side effects• Just as we saw adverse events with ephedrine, it ispredicted that we will continue to hear reports of adverseevents, failed drug tests, and the potential for productrecalls with MHA.

FEBRUARY 2012• NEW YORK—Abbey Spanier Rodd & Abrams LLP filed a class actionlawsuit against General Nutrition Centers Inc. (GNC)and other retailers for selling Cellucor's C-4 Extreme,which the companies marketed as a dietary supplement,but the law firm said it actually contains the "whollysynthetic" ingredient 1,3 Dimethylamylamine (DMAA)/MHA• The plaintiff alleges that the defendants failed todisclose that the DMAA/MHA contained in C-4Extreme is wholly synthetic, manufactured and notderived from the geranium plant.

BANNED INGREDIENT LISTENERGY DRINKSStimulants can cause positive anti-doping testsOn the Prohibited List as:MethylhexaneamineBut sometimes also called:Geranium (extract, stems, or oil),geranamine,“geranium surge” and other madeupnames.1,3‐Dimethylamyline,dimethylpentylamine.Octopamine β,4‐Dihydroxyphenethylamine; p‐Hydroxymandelamine; ND‐50;Noroxedrine;p‐NorsynephrineOxilofrinePhenpromethylamineMethylsynephrineFenprometamina; Phenpromethamine;Phenpromethaminum; Phenylpropylmethylamine;“Benzedrine”. Benzedrine itself is anamphetamine like stimulant, but it seems thename may also be used as code forphenpromethylamine.Acacia rigidula (the ingredient labelmay list this plant but the product might havephenpreomethylamine and other substances in it).

WHERE IS THE ENERGY?Five Hour Energy Drink contains:Caffeine- never lists the amount on labelCiticoline – “Smart Drug” which stimulates nervesB vitaminsB6 – 2000% of the Daily Value –– amounts greater than 200mg leads to a decrease inMuscle CoordinationB 12 – 8333% of the Daily ValueIt does NOT provide ENERGY ONLY STIMULANTSTAKING LARGE AMOUNTS OF B VITAMINS WILL NOTSPEED UP THE RELEASE OF ENERGY FROM FOODSStimulants bind to neurons and activate them.But stimulants cannot substitute for glucose.

Are there short-term dangers todrinking energy drinks?• Individual responses to caffeine vary, and thesedrinks should be treated carefully because of howpowerful they are.• Energy drinks' stimulating properties can boost theheart rate and blood pressure (sometimes to thepoint of palpitations), dehydrate the body, and, likeother stimulants, prevent sleep.• Energy drinks should not be used while exercisingas the combination of fluid loss from sweating andthe diuretic quality of the caffeine can leavesomeone severely dehydrated.

BUT YOUR ATHLETE STILL WANTS TOTAKE A SUPPLEMENT .WHAT IS THE NEXT STEP?SUPPLEMENTWEB SITE OF COMPANYCONSUMERLAB.COMPRODUCTINFORMATIONSHOW BOTH SIDES – Science and Media HypeJUST DON’T SAY “IT DOESN’T WORK”

1 MR by BPI SPORTS

1 MR Advertisement• 1 MR requires thatyou mix one serving ofone of the mostpowerful trainingpowders on the planetwith 4-6 ounces ofwater. That’s it.Combine that with oneof the best tastes andyou have 1MR.• 1 MR hits you fast.• 1 MR is designed tohelp you experience thebest workouts of yourlife.• 1 MR is anundergroundphenomenon. We didn’tget here by tricking youinto buying our product.

WHAT TO LOOK UP?• WHAT DOES IT DO?– CLAIMS– BENEFITS– ACTIVE INGREDIENTS– SIDE EFFECTS– IS IT BANNED?– DELIVERY SYSTEMBIOAVAILABILITY – ¼ CUP OF VINEGAR

WHAT TO LOOK UP?• SUPPLY/CONTAINER– # MG OR GM PER DAY– PILL OR POWDER– COST– TOTAL SUPPY PER CONTAINER

WHAT TO LOOK UP?• SUPPLY/CONTAINER– # MG OR GM PER DAY: 1 serving/8grams/1 scoop– PILL OR POWDER: POWDER– COST: 224 gms $65.95 on SALE for$29.95 (80 gm/$9.99=$0.08)– TOTAL SUPPY PER CONTAINER: 28

WHAT TO LOOK UP?• SUGGESTED USE– DOSAGE– EMPTY OR FULL STOMACH– HYDRATION– RELATIONSHIP TO WORKOUT

WHAT TO LOOK UP?• SUGGESTED USE– DOSAGE: 1 Scoop or as suggested by aqualified healthcare practitioner– EMPTY OR FULL STOMACH: Not noted– HYDRATION: Not noted– RELATIONSHIP TO WORKOUT: 15-30minutes prior to training

WOULD YOUR ATHLETEANSWER YES OR NO…..• Is the supplement (or ingredients) legalfor the sport governing body?• Is there evidence of safety?• Is there evidence of third partyverification for truth in labeling and nobanned substances?• Is there evidence of efficacy?– Notice dosage and application

• IF THE ATHLETE ANSWERS NO TOANY OF THE PREVIOUSQUESTIONS:• Health and/or eligibility may be at risk!

WHAT DO YOU TELLYOUR ATHLETE?

The Essential Considerations• Safety• Efficacy

SAFETY• Federal regulations do not require supplementsmanufacturers to provide evidence of safety.• Athletic trainers should be aware of resources toidentify products associated with adverse effects.• Athletes should be educated about this lack ofregulation, and are ultimately responsible for thehealth and eligibility risks as a result.

RECALLED SUPPLEMENTShttp://www.fda.gov/Drugs/ResourcesForYou/Consumers/QuestionsAnswers/ucm136187.htm

Appendix 3a – Safety Resources• Quackwatch• USADA• RECALLED SUPPLEMENTS• CENTER FOR DRUGEVALUATIONAND RESEARCH

EFFICACY• Dietary supplement manufacturers are notrequired to provide evidence of efficacy.• Product efficacy is determined by the quantity andmixture of active ingredients in the productapplied under similar circumstances to thosedemonstrated effective in peer-reviewed research.• Athletic trainers should be aware of resources toidentify supplements (or individual components)supported by scientific evidence, and theappropriate circumstance for use.

Appendix 3d – EfficacyResources and Fact Sheets• National Institute of Health• Natural Medicines Database• The Natural Pharmacist• Sports, Cardiovascular and WellnessNutritionists Practice Group• Australian Institute of Sport

CRITICALLY EVALUATE• BE SUSPICIOUS• BE SKEPTICAL OF ADS• SCRUTINIZE CLAIMS• LOOK AT SELF-STUDIES• USE COMMON SENSEENCOURAGE FOOD VS.SUPPLEMENTS

OFFICE OF DIETARYSUPPLEMENTS• 6100 EXECUTIVE BOULEVARD• ROOM 3801, MSC 7517• BETHESDA, MD 20892-7517• E-MAIL: ODS@NIH.GOV• WEB SITE: http://ods.od.nih.gov

U.S. ANTI-DOPING AGENCY• NEW: 411 AT USADAhttp://www.usada.org/supplement411/reduce-the risk/choose-ingredients• Updated February 19, 2012 - Not a Complete List•Products that have been tested and shown to containprohibited substances.Product Company What's on the label? OnProhibited List (or Category of Prohibited List)

Questions?