Evaluation of Metabolism-Boosting Beverages

Appetite Clinical Trial

Official title:

The Effect of Metabolism-Boosting Beverages on 24 Hr Energy Expenditure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01029236
• Other study ID #: MED010
• Secondary ID: 20070530
• Status: Completed
• Phase: N/A
• First received: December 7, 2009
• Last updated: December 8, 2009
• Start date: June 2007
• Est. completion date: December 2007

Study information

• Verified date: December 2009
• Source: Medifast, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Appetite
• Energy Expenditure

Intervention

Other:
• Medifast Metabolism-boosting Beverages
Medifast metabolism-boosting beverages containing 90 mg EGCG and 100 mg caffeine.

Locations

Country	Name	City	State
United States	Medifast Inc.	Owings Mills	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Medifast, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (27)

Abbott RD, Ross GW, White LR, Nelson JS, Masaki KH, Tanner CM, Curb JD, Blanchette PL, Popper JS, Petrovitch H. Midlife adiposity and the future risk of Parkinson's disease. Neurology. 2002 Oct 8;59(7):1051-7. — View Citation

Acheson KJ, Schutz Y, Bessard T, Anantharaman K, Flatt JP, Jéquier E. Glycogen storage capacity and de novo lipogenesis during massive carbohydrate overfeeding in man. Am J Clin Nutr. 1988 Aug;48(2):240-7. — View Citation

Allison DB, Gadbury G, Schwartz LG, Murugesan R, Kraker JL, Heshka S, Fontaine KR, Heymsfield SB. A novel soy-based meal replacement formula for weight loss among obese individuals: a randomized controlled clinical trial. Eur J Clin Nutr. 2003 Apr;57(4):514-22. — View Citation

Bérubé-Parent S, Pelletier C, Doré J, Tremblay A. Effects of encapsulated green tea and Guarana extracts containing a mixture of epigallocatechin-3-gallate and caffeine on 24 h energy expenditure and fat oxidation in men. Br J Nutr. 2005 Sep;94(3):432-6. — View Citation

Borchardt RT, Huber JA. Catechol O-methyltransferase. 5. Structure-activity relationships for inhibition by flavonoids. J Med Chem. 1975 Jan;18(1):120-2. — View Citation

Curatolo PW, Robertson D. The health consequences of caffeine. Ann Intern Med. 1983 May;98(5 Pt 1):641-53. Review. — View Citation

den Besten C, Vansant G, Weststrate JA, Deurenberg P. Resting metabolic rate and diet-induced thermogenesis in abdominal and gluteal-femoral obese women before and after weight reduction. Am J Clin Nutr. 1988 May;47(5):840-7. — View Citation

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. — View Citation

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. — View Citation

Dulloo AG. Ephedrine, xanthines and prostaglandin-inhibitors: actions and interactions in the stimulation of thermogenesis. Int J Obes Relat Metab Disord. 1993 Feb;17 Suppl 1:S35-40. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Golay A, Schutz Y, Meyer HU, Thiébaud D, Curchod B, Maeder E, Felber JP, Jéquier E. Glucose-induced thermogenesis in nondiabetic and diabetic obese subjects. Diabetes. 1982 Nov;31(11):1023-8. — View Citation

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. — View Citation

Hedley AA, Ogden CL, Johnson CL, Carroll MD, Curtin LR, Flegal KM. Prevalence of overweight and obesity among US children, adolescents, and adults, 1999-2002. JAMA. 2004 Jun 16;291(23):2847-50. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Segal KR, Albu J, Chun A, Edano A, Legaspi B, Pi-Sunyer FX. Independent effects of obesity and insulin resistance on postprandial thermogenesis in men. J Clin Invest. 1992 Mar;89(3):824-33. — View Citation

Segal KR, Gutin B, Nyman AM, Pi-Sunyer FX. Thermic effect of food at rest, during exercise, and after exercise in lean and obese men of similar body weight. J Clin Invest. 1985 Sep;76(3):1107-12. — View Citation

Thearle M, Aronne LJ. Obesity and pharmacologic therapy. Endocrinol Metab Clin North Am. 2003 Dec;32(4):1005-24. Review. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the effect of MBBs on REE by performing indirect calorimetry		30, 60, 90, and 120 minutes	No
Secondary	To assess the effect of MBBs on appetite via visual analogue scales		30, 60, 90, and 120 minutes	No