NCT00692731

Brief Summary

The primary objective of this trial is to evaluate the influence of consuming a tea catechin containing sports beverage on body fat mass during exercise-induced weight loss among overweight and obese men and women.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2006

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 6, 2008

Completed
Last Updated

June 6, 2008

Status Verified

June 1, 2008

Enrollment Period

1.1 years

First QC Date

June 4, 2008

Last Update Submit

June 4, 2008

Conditions

OverweightObesity

Keywords

green tea,polyphenols,weight loss,body fat

Outcome Measures

Primary Outcomes (1)

  • Changes in body fat mass.

    Baseline to end-of-treatment

Secondary Outcomes (1)

  • Changes in body weight

    Baseline to end-of-treatment

Study Arms (2)

Active

Tea catechin sport beverage

Dietary Supplement: 500 mL/day of a beverage providing approximately 625 mg catechins

Control

Control beverage

Other: Control beverage matched for energy and caffeine content

Interventions

500 mL/day of a beverage providing approximately 625 mg catechinsDIETARY_SUPPLEMENT

Subjects were asked to consume 500 mL/day of a beverage providing approximately 625 mg catechins

Active
Control beverage matched for energy and caffeine contentOTHER

500 mL/day of a control beverage

Control

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subjects included generally healthy, normally sedentary men and women. Eligible participants were required to be 21 to 65 years of age, have a waist circumference ≥ 87 cm (women) or ≥ 90 cm (men), and total cholesterol ≥ 200 mg/dL at screening.

You may qualify if:

  • Men and women 21 to 65 years of age, inclusive
  • Waist circumference ≥ 87 cm for women and ≥ 90 cm for men at screening
  • Total cholesterol ≥ 200 mg/dL
  • Provide written informed consent and authorization for protected health information

You may not qualify if:

  • Volunteers with Body mass index ≥ 40.0 kg/m2 or \< 25.0 kg/m2;
  • Recent weight loss of more than 4.5 kg;
  • Recent use of any weight loss medications, supplements, or programs;
  • History of weight-reducing surgery or an eating disorder
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Meridien Research

St. Petersburg, Florida, 33709, United States

Location

Provident Clinical Research

Bloomington, Indiana, 47403, United States

Location

Related Publications (4)

  • Murase T, Nagasawa A, Suzuki J, Hase T, Tokimitsu I. Beneficial effects of tea catechins on diet-induced obesity: stimulation of lipid catabolism in the liver. Int J Obes Relat Metab Disord. 2002 Nov;26(11):1459-64. doi: 10.1038/sj.ijo.0802141.

    PMID: 12439647BACKGROUND

  • Dulloo AG, Duret C, Rohrer D, Girardier L, Mensi N, Fathi M, Chantre P, Vandermander J. Efficacy of a green tea extract rich in catechin polyphenols and caffeine in increasing 24-h energy expenditure and fat oxidation in humans. Am J Clin Nutr. 1999 Dec;70(6):1040-5. doi: 10.1093/ajcn/70.6.1040.

    PMID: 10584049BACKGROUND

  • Nagao T, Komine Y, Soga S, Meguro S, Hase T, Tanaka Y, Tokimitsu I. Ingestion of a tea rich in catechins leads to a reduction in body fat and malondialdehyde-modified LDL in men. Am J Clin Nutr. 2005 Jan;81(1):122-9. doi: 10.1093/ajcn/81.1.122.

    PMID: 15640470BACKGROUND

  • Nagao T, Hase T, Tokimitsu I. A green tea extract high in catechins reduces body fat and cardiovascular risks in humans. Obesity (Silver Spring). 2007 Jun;15(6):1473-83. doi: 10.1038/oby.2007.176.

    PMID: 17557985BACKGROUND

MeSH Terms

Conditions

OverweightObesityWeight Loss

Interventions

Catechin

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Intervention Hierarchy (Ancestors)

ChromansBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFlavonoidsChromonesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Kevin C Maki, PhD

    Provident Clinical Research

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 4, 2008

First Posted

June 6, 2008

Study Start

June 1, 2006

Primary Completion

July 1, 2007

Study Completion

August 1, 2007

Last Updated

June 6, 2008

Record last verified: 2008-06

Locations

US(2)