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Evaluation of Metabolism-Boosting Beverages

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ClinicalTrials.gov Identifier: NCT01029236
Recruitment Status : Completed
First Posted : December 9, 2009
Last Update Posted : December 9, 2009
Sponsor:
Information provided by:
Medifast, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Energy Expenditure Appetite Other: Medifast Metabolism-boosting Beverages Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effect of Metabolism-Boosting Beverages on 24 Hr Energy Expenditure
Study Start Date : June 2007
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007
Arms and Interventions
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Intervention Details:
  • Other: Medifast Metabolism-boosting Beverages
    Medifast metabolism-boosting beverages containing 90 mg EGCG and 100 mg caffeine.

Outcome Measures
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Primary Outcome Measures :
  1. To assess the effect of MBBs on REE by performing indirect calorimetry [ Time Frame: 30, 60, 90, and 120 minutes ]

Secondary Outcome Measures :
  1. To assess the effect of MBBs on appetite via visual analogue scales [ Time Frame: 30, 60, 90, and 120 minutes ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01029236


Locations
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United States, Maryland
Medifast Inc.
Owings Mills, Maryland, United States, 21117
Sponsors and Collaborators
Medifast, Inc.
Investigators
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Principal Investigator: Lisa M Davis, PhD, PA-C Medifast, Inc.
Study Director: Christopher D Coleman, MS,RD,LDN Medifast, Inc.
More Information
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Publications:

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Responsible Party: Lisa M. Davis, PhD, PA-C/ Vice President of Research and Development, Medifast Inc.
ClinicalTrials.gov Identifier: NCT01029236    
Other Study ID Numbers: MED010
20070530 ( Other Identifier: Western Institutional Review Board )
First Posted: December 9, 2009    Key Record Dates
Last Update Posted: December 9, 2009
Last Verified: December 2009
Keywords provided by Medifast, Inc.:
obesity
metabolism
weight loss
energy expenditure
 thermogenesis
Metabolism-Boosting Beverages effect on REE
Metabolism-Boosting Beverages effect on appetite