Evaluation of Metabolism-Boosting Beverages

NCT01029236 | Completed

• 2 other identifiers: MED01020070530
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Energy Expenditure; Appetite

Keywords

obesity; metabolism; weight loss; energy expenditure; thermogenesis; Metabolism-Boosting Beverages effect on REE; Metabolism-Boosting Beverages effect on appetite

Outcome Measures

Primary Outcomes (1)

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

  30, 60, 90, and 120 minutes

Secondary Outcomes (1)

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

  30, 60, 90, and 120 minutes

Interventions

Medifast Metabolism-boosting Beverages OTHER

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medifast, Inc.: lead

Study Sites (1)

Medifast Inc.

Owings Mills, Maryland, 21117, United States

Location

Related Publications (27)

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MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Lisa M Davis, PhD, PA-C

  Medifast, Inc.

  PRINCIPAL INVESTIGATOR

• Christopher D Coleman, MS,RD,LDN

  Medifast, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 7, 2009
• First Posted: December 9, 2009
• Study Start: June 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: December 9, 2009

Record last verified: 2009-12

Locations

US (1)