Evaluation of Metabolism-Boosting Beverages - Full Text View

Sponsor:	Medifast, Inc.
Information provided by:	Medifast, Inc.
ClinicalTrials.gov Identifier:	NCT01029236

Purpose

The purpose of this study is to assess the effect of Metabolism-boosting Beverages (MBB) containing green tea extract with a standardized amount of epigallocatechin gallate (EGCG) and caffeine.

Condition	Intervention
Energy Expenditure Appetite	Other: Medifast Metabolism-boosting Beverages

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science
Official Title:	The Effect of Metabolism-Boosting Beverages on 24 Hr Energy Expenditure

Resource links provided by NLM:

MedlinePlus related topics: Caffeine

U.S. FDA Resources

Further study details as provided by Medifast, Inc.:

Primary Outcome Measures:

To assess the effect of MBBs on REE by performing indirect calorimetry [ Time Frame: 30, 60, 90, and 120 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess the effect of MBBs on appetite via visual analogue scales [ Time Frame: 30, 60, 90, and 120 minutes ] [ Designated as safety issue: No ]

Enrollment:	30
Study Start Date:	June 2007
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Intervention Details:

Medifast metabolism-boosting beverages containing 90 mg EGCG and 100 mg caffeine.

Detailed Description:

The study will assess the effect of MBB's on 24 hour energy expenditure by performing indirect calorimetry, and on appetite using visual analogue scales (VAS). The planned sample size is 54 healthy male and female adults, both lean and overweight. We plan to test 6 metabolism-boosting beverages in the following order: 1) Raspberry Tea 2) Banana Shake 3) Chai Latte 4) Strawberry Shake 5) Cappuccino 6) Hot Cocoa. In the order that they are screened, each subject will be assigned to receive 1 of 6 Metabolism-boosting beverages. Each MBB will contain 90 mg EGCG and 100 mg caffeine.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Adult males and females (age between 18 and 65)
BMI ≥18.5 - ≤ 40.0 kg/m2
Non-smokers
No known food allergies to wheat, gluten, soy or nuts
≤ 14 alcoholic beverages per week
No sensitivity to caffeine or green tea
No alcohol or caffeine on days when metabolism is tested
Willing and able to give informed consent
Not currently using appetite-affecting medications (e.g SSRIs, steroids, Ritalin)
Not pregnant or lactating

Exclusion Criteria:

Actively dieting
Chronic uncontrolled health problems (not including obesity or controlled: type-2 diabetes, hyperlipidemia, hypertension)
History of arrhythmia, or taking anti-arrhythmic medications (e.g. propafenone)
Schizophrenia, history of bipolar disorder, current Major Depressive Disorder
Dependence on alcohol or sedative-hypnotic drugs (e.g. benzodiazepines)
Cognitive impairment severe enough to preclude informed consent
Taking weight loss or appetite-suppressant medications
Taking appetite affecting medications (e.g. SSRIs, steroids, Ritalin)
Food allergies to wheat, gluten, soy, or nuts
Sensitivity to caffeine or green tea

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01029236

Locations

United States, Maryland
Medifast Inc.
Owings Mills, Maryland, United States, 21117

Sponsors and Collaborators

Medifast, Inc.

Investigators

Principal Investigator:	Lisa M Davis, PhD, PA-C	Medifast, Inc.
Study Director:	Christopher D Coleman, MS,RD,LDN	Medifast, Inc.

More Information

Publications:

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Diepvens K, Westerterp KR, Westerterp-Plantenga MS. Obesity and thermogenesis related to the consumption of caffeine, ephedrine, capsaicin, and green tea. Am J Physiol Regul Integr Comp Physiol. 2007 Jan;292(1):R77-85. Epub 2006 Jul 13. Review.

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Dulloo AG, Duret C, Rohrer D, Girardier L, Mensi N, Fathi M, Chantre P, Vandermander J. Efficacy of a green tea extract rich in catechin polyphenols and caffeine in increasing 24-h energy expenditure and fat oxidation in humans. Am J Clin Nutr. 1999 Dec;70(6):1040-5.

Festi D, Colecchia A, Sacco T, Bondi M, Roda E, Marchesini G. Hepatic steatosis in obese patients: clinical aspects and prognostic significance. Obes Rev. 2004 Feb;5(1):27-42. Review.

Gale SM, Castracane VD, Mantzoros CS. Energy homeostasis, obesity and eating disorders: recent advances in endocrinology. J Nutr. 2004 Feb;134(2):295-8. Review.

Gougeon R, Harrigan K, Tremblay JF, Hedrei P, Lamarche M, Morais JA. Increase in the thermic effect of food in women by adrenergic amines extracted from citrus aurantium. Obes Res. 2005 Jul;13(7):1187-94.

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Heymsfield SB, van Mierlo CA, van der Knaap HC, Heo M, Frier HI. Weight management using a meal replacement strategy: meta and pooling analysis from six studies. Int J Obes Relat Metab Disord. 2003 May;27(5):537-49.

Keaney JF Jr, Larson MG, Vasan RS, Wilson PW, Lipinska I, Corey D, Massaro JM, Sutherland P, Vita JA, Benjamin EJ; Framingham Study. Obesity and systemic oxidative stress: clinical correlates of oxidative stress in the Framingham Study. Arterioscler Thromb Vasc Biol. 2003 Mar 1;23(3):434-9. Epub 2003 Jan 30.

Klaus S, Pültz S, Thöne-Reineke C, Wolfram S. Epigallocatechin gallate attenuates diet-induced obesity in mice by decreasing energy absorption and increasing fat oxidation. Int J Obes (Lond). 2005 Jun;29(6):615-23.

Pouliot MC, Després JP, Nadeau A, Moorjani S, Prud'Homme D, Lupien PJ, Tremblay A, Bouchard C. Visceral obesity in men. Associations with glucose tolerance, plasma insulin, and lipoprotein levels. Diabetes. 1992 Jul;41(7):826-34.

Fiorini RN, Donovan JL, Rodwell D, Evans Z, Cheng G, May HD, Milliken CE, Markowitz JS, Campbell C, Haines JK, Schmidt MG, Chavin KD. Short-term administration of (-)-epigallocatechin gallate reduces hepatic steatosis and protects against warm hepatic ischemia/reperfusion injury in steatotic mice. Liver Transpl. 2005 Mar;11(3):298-308.

Rumpler W, Seale J, Clevidence B, Judd J, Wiley E, Yamamoto S, Komatsu T, Sawaki T, Ishikura Y, Hosoda K. Oolong tea increases metabolic rate and fat oxidation in men. J Nutr. 2001 Nov;131(11):2848-52.

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Rudelle S, Ferruzzi MG, Cristiani I, Moulin J, Macé K, Acheson KJ, Tappy L. Effect of a thermogenic beverage on 24-hour energy metabolism in humans. Obesity (Silver Spring). 2007 Feb;15(2):349-55.

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Westerterp-Plantenga MS, Lejeune MP, Kovacs EM. Body weight loss and weight maintenance in relation to habitual caffeine intake and green tea supplementation. Obes Res. 2005 Jul;13(7):1195-204.

Yoshioka M, Doucet E, Drapeau V, Dionne I, Tremblay A. Combined effects of red pepper and caffeine consumption on 24 h energy balance in subjects given free access to foods. Br J Nutr. 2001 Feb;85(2):203-11.

Responsible Party:	Medifast Inc. ( Lisa M. Davis, PhD, PA-C/ Vice President of Research and Development )
ClinicalTrials.gov Identifier:	NCT01029236 History of Changes
Other Study ID Numbers:	MED010, 20070530
Study First Received:	December 7, 2009
Last Updated:	December 8, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by Medifast, Inc.:

obesity
metabolism
weight loss
energy expenditure

thermogenesis
Metabolism-Boosting Beverages effect on REE
Metabolism-Boosting Beverages effect on appetite

ClinicalTrials.gov processed this record on September 01, 2010