AzTrials
AzTrials

Energy ExpenditureNCT01029236

Evaluation of Metabolism-Boosting Beverages

A study testing Medifast Metabolism-boosting Beverages in people with Energy Expenditure and Appetite, run by Medifast, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Energy Expenditure, Appetite
What is being tested?
Medifast Metabolism-boosting Beverages
How many people
30 participants
Where
1 siteUnited States
Study dates
Jun 2007to Dec 2007
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Medifast Inc.

    Owings Mills, Maryland, 21117

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Medifast Metabolism-boosting Beverages
Keywords
obesity, metabolism, weight loss, energy expenditure, thermogenesis, Metabolism-Boosting Beverages effect on REE, Metabolism-Boosting Beverages effect on appetite
Medical subject headings
Obesity, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Medifast Metabolism-boosting BeveragesOther

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To assess the effect of MBBs on REE by performing indirect calorimetry

    Measured: 30, 60, 90, and 120 minutes

Secondary outcomes (1)

  1. To assess the effect of MBBs on appetite via visual analogue scales

    Measured: 30, 60, 90, and 120 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2009 (estimated)
  2. Study startJun 2007
  3. Primary completionDec 2007
  4. Study completionDec 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01029236
Sponsor's protocol ID
MED010
Other IDs
20070530
Status last verified
Dec 2009
First submitted
7 Dec 2009
Last updated
9 Dec 2009
Results posted
No
Data monitoring committee
No

Publications

  • Berube-Parent S, Pelletier C, Dore 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. doi: 10.1079/bjn20051502.

    PubMed 16176615

  • Acheson KJ, Schutz Y, Bessard T, Anantharaman K, Flatt JP, Jequier E. Glycogen storage capacity and de novo lipogenesis during massive carbohydrate overfeeding in man. Am J Clin Nutr. 1988 Aug;48(2):240-7. doi: 10.1093/ajcn/48.2.240.

    PubMed 3165600

  • Golay A, Schutz Y, Meyer HU, Thiebaud D, Curchod B, Maeder E, Felber JP, Jequier E. Glucose-induced thermogenesis in nondiabetic and diabetic obese subjects. Diabetes. 1982 Nov;31(11):1023-8. doi: 10.2337/diacare.31.11.1023. No abstract available.

    PubMed 6757011

  • 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. doi: 10.1172/JCI115661.

    PubMed 1541675

  • 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. doi: 10.1093/ajcn/47.5.840.

    PubMed 3364400

  • 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. doi: 10.1212/wnl.59.7.1051.

    PubMed 12370461

  • 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. doi: 10.1038/sj.ejcn.1601587.

    PubMed 12700612

  • Borchardt RT, Huber JA. Catechol O-methyltransferase. 5. Structure-activity relationships for inhibition by flavonoids. J Med Chem. 1975 Jan;18(1):120-2. doi: 10.1021/jm00235a030. No abstract available.

    PubMed 1109569

  • Curatolo PW, Robertson D. The health consequences of caffeine. Ann Intern Med. 1983 May;98(5 Pt 1):641-53. doi: 10.7326/0003-4819-98-5-641.

    PubMed 6342491

  • 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. doi: 10.1152/ajpregu.00832.2005. Epub 2006 Jul 13.

    PubMed 16840650

  • 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.

    PubMed 8384178

  • 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. doi: 10.1093/ajcn/70.6.1040.

    PubMed 10584049

  • 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. doi: 10.1111/j.1467-789x.2004.00126.x.

    PubMed 14969505

  • Gale SM, Castracane VD, Mantzoros CS. Energy homeostasis, obesity and eating disorders: recent advances in endocrinology. J Nutr. 2004 Feb;134(2):295-8. doi: 10.1093/jn/134.2.295.

    PubMed 14747663

  • 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. doi: 10.1038/oby.2005.141.

    PubMed 16076988

Questions about this trial

What is this clinical trial studying?

A study testing Medifast Metabolism-boosting Beverages in people with Energy Expenditure and Appetite, run by Medifast, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess the effect of MBBs on REE by performing indirect calorimetry (time frame: 30, 60, 90, and 120 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01029236, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2009.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in