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Completed

NCT Number: NCT01029236

Evaluation of Metabolism-Boosting Beverages

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medifast Inc.

Owings Mills, Maryland, 21117, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medifast Metabolism-boosting Beverages

Other

Medifast metabolism-boosting beverages containing 90 mg EGCG and 100 mg caffeine.

Primary outcomes

  1. To assess the effect of MBBs on REE by performing indirect calorimetry

    Time frame: 30, 60, 90, and 120 minutes

Secondary outcomes

  1. To assess the effect of MBBs on appetite via visual analogue scales

    Time frame: 30, 60, 90, and 120 minutes

Sponsors and collaborators

Lead sponsor

Medifast, Inc.

Industry

Registry information

Official study title

The Effect of Metabolism-Boosting Beverages on 24 Hr Energy Expenditure

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Dec 9, 2009
Registry last updated
Dec 9, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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