Clinical trial NCT01029236: Evaluation of Metabolism-Boosting Beverages
Official title: The Effect of Metabolism-Boosting Beverages on 24 Hr Energy Expenditure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Energy Expenditure
Appetite
Keywords: obesity
metabolism
weight loss
energy expenditure
thermogenesis
Metabolism-Boosting Beverages effect on REE
Metabolism-Boosting Beverages effect on appetite
Lead sponsor: Medifast, Inc.
Sponsor class: INDUSTRY
First posted: 2009-12-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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

Primary outcomes:
measure: To assess the effect of MBBs on REE by performing indirect calorimetry
timeFrame: 30, 60, 90, and 120 minutes
Secondary outcomes:
measure: To assess the effect of MBBs on appetite via visual analogue scales
timeFrame: 30, 60, 90, and 120 minutes
Other outcomes:
Locations:
city: Owings Mills
country: United States
facility: Medifast Inc.
state: Maryland
Study officials:
affiliation: Medifast, Inc.
name: Lisa M Davis, PhD, PA-C
role: PRINCIPAL_INVESTIGATOR
affiliation: Medifast, Inc.
name: Christopher D Coleman, MS,RD,LDN
role: STUDY_DIRECTOR
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