Evaluation of Metabolism-Boosting Beverages

This study has been completed.
Sponsor:
Information provided by:
Medifast, Inc.
ClinicalTrials.gov Identifier:
NCT01029236
First received: December 7, 2009
Last updated: December 8, 2009
Last verified: December 2009
  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

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:
    Other: Medifast Metabolism-boosting Beverages
    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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:

Responsible Party: Lisa M. Davis, PhD, PA-C/ Vice President of Research and Development, Medifast Inc.
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 30, 2014