Evaluation of Metabolism-Boosting Beverages

M

Medifast

Status

Completed

Conditions

Energy Expenditure
Appetite

Treatments

Other: Medifast Metabolism-boosting Beverages

Study type

Interventional

Funder types

Industry

Identifiers

NCT01029236
20070530 (Other Identifier)
MED010

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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