Evaluation of Metabolism-Boosting Beverages

December 8, 2009 updated by: Medifast, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess the effect of MBBs on REE by performing indirect calorimetry
Time Frame: 30, 60, 90, and 120 minutes
30, 60, 90, and 120 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess the effect of MBBs on appetite via visual analogue scales
Time Frame: 30, 60, 90, and 120 minutes
30, 60, 90, and 120 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medifast, Inc.

Investigators

  • Study Director: Christopher D Coleman, MS,RD,LDN, Medifast, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (ACTUAL)

December 1, 2007

Study Completion (ACTUAL)

December 1, 2007

Study Registration Dates

First Submitted

December 7, 2009

First Submitted That Met QC Criteria

December 8, 2009

First Posted (ESTIMATE)

December 9, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

December 9, 2009

Last Update Submitted That Met QC Criteria

December 8, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MED010
  • 20070530 (OTHER: Western Institutional Review Board)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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