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Evaluation of Metabolism-Boosting Beverages
This study has been completed.
Study NCT01029236   Information provided by Medifast, Inc.

First Received on December 7, 2009.   Last Updated on December 8, 2009   History of Changes

December 7, 2009
December 8, 2009
June 2007
December 2007   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01029236 on ClinicalTrials.gov Archive Site
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 ]
Same as current
 
Evaluation of Metabolism-Boosting Beverages
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.

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.

Interventional
 
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Energy Expenditure
  • Appetite
Other: Medifast Metabolism-boosting Beverages
Medifast metabolism-boosting beverages containing 90 mg EGCG and 100 mg caffeine.
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
December 2007
December 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01029236
MED010, 20070530
No
Lisa M. Davis, PhD, PA-C/ Vice President of Research and Development, Medifast Inc.
Medifast, Inc.
 
Principal Investigator: Lisa M Davis, PhD, PA-C Medifast, Inc.
Study Director: Christopher D Coleman, MS,RD,LDN Medifast, Inc.
Medifast, Inc.
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP