Evaluation of Metabolism-Boosting Beverages

Not Applicable

Completed

• Conditions: Appetite; Energy Expenditure

• Registration Number: NCT01029236
• Lead Sponsor: Medifast, Inc.

Brief 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.

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 Timeline

• Study Start: 2007-06
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2009-12
• Study First Submitted: 2009-12-07
• Study First Submitted QC: 2009-12-08
• Last Update Submitted: 2009-12-08
• Study First Posted: 2009-12-09
• Last Update Posted: 2009-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To assess the effect of MBBs on REE by performing indirect calorimetry	30, 60, 90, and 120 minutes

Secondary Outcome Measures

Name	Time	Method
To assess the effect of MBBs on appetite via visual analogue scales	30, 60, 90, and 120 minutes

Trial Locations

Locations (1)

Medifast Inc.; 🇺🇸 Owings Mills, Maryland, United States