OverweightNCT00692731
Efficacy of a Tea Catechin Sports Drink for Enhancing Exercise-Induced Fat Loss
An observational study of Overweight and Obesity, run by Provident Clinical Research at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- 500 mL/day of a beverage providing approximately 625 mg catechins
- How many people
- 132 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2006to Aug 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Provident Clinical Research
Bloomington, Indiana, 47403
Meridien Research
St. Petersburg, Florida, 33709
About this study
Official title: A Randomized, Double-Blind, Controlled Study to Assess the Efficacy of a Tea Catechin Sports Drink for Enhancing Exercise-Induced Fat Loss
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.
Read the detailed description
The study will include two screening/baseline visits and six treatment visits over 12 weeks. During the treatment phase of the study, subjects will be instructed to consume one bottle of sports drink (500 ml) daily (total consumption of tea catechins in the active group = 540 mg/d). Subjects will be asked to maintain a constant energy intake throughout the study period. Three-day diet records will be collected and analyzed at weeks 0, 6, and 12 to evaluate consistency of energy intake.
All subjects will engage in an exercise program with a goal of maintaining 180 min/week of low- to moderate-intensity exercise (e.g., walking and other aerobic activities, 4-6 days per week). Three of the weekly exercise sessions will be supervised and 1-3 will be unsupervised. Subjects will be asked to wear a pedometer and record their daily physical activity (steps) each night in a physical activity diary. Diaries will be collected at each visit and used to evaluate exercise compliance. Dual energy X-ray absorptiometry (DEXA) and computed tomography (CT) scans will be performed at baseline (week 0) and at the end of the treatment (week 12). Additionally, body weight and abdominal circumference will be assessed at every clinic visit during the study. It is anticipated that subjects will expend 1000-1800 kcal per week above their baseline level in deliberate physical activity. Accordingly, the control group is expected to lose 1.5 to 2.8 kg of body fat during the 12-week treatment period
- Conditions
- Overweight, Obesity
- Being tested
- 500 mL/day of a beverage providing approximately 625 mg catechins, Control beverage matched for energy and caffeine content
- Keywords
- green tea,, polyphenols,, weight loss,, body fat
- Medical subject headings
- Overweight, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Control beverage matched for energy and caffeine contentOther
500 mL/day of a control beverage
| Study group | Role | What they receive |
|---|---|---|
| Active | Tea catechin sport beverage Receives: Dietary Supplement: 500 mL/day of a beverage providing approximately 625 mg catechins | |
| Control | Control beverage Receives: Other: Control beverage matched for energy and caffeine content |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in body fat mass.
Measured: Baseline to end-of-treatment
Secondary outcomes (1)
Changes in body weight
Measured: Baseline to end-of-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2008 (estimated)
- Study startJun 2006
- Primary completionJul 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Provident Clinical Research
- Sponsor type
- University, hospital or other
- Collaborators
- Kao (Taiwan) Corporation
- Investigators
- Kevin C Maki, PhD, Study director, Provident Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00692731
- Sponsor's protocol ID
- PRV-06001
- Status last verified
- Jun 2008
- First submitted
- 4 Jun 2008
- Last updated
- 6 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 12439647Dulloo 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.
PubMed 10584049Nagao 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.
PubMed 15640470Nagao 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.
PubMed 17557985
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Controlled Study to Assess the Efficacy of a Tea Catechin Sports Drink for Enhancing Exercise-Induced Fat Loss
- ClinicalTrials.gov ID
- NCT00692731
- Acronym / sponsor ID
- PRV-06001
- Conditions
- Overweight, Obesity
- Keywords
- green tea,, polyphenols,, weight loss,, body fat
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Provident Clinical ResearchUniversity, hospital or other
- Collaborators
- Kao (Taiwan) Corporation
- Study start
- Jun 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 6 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will include two screening/baseline visits and six treatment visits over 12 weeks. During the treatment phase of the study, subjects will be instructed to consume one bottle of sports drink (500 ml) daily (total consumption of tea catechins in the active group = 540 mg/d). Subjects will be asked to maintain a constant energy intake throughout the study period. Three-day diet records will be collected and analyzed at weeks 0, 6, and 12 to evaluate consistency of energy intake.
All subjects will engage in an exercise program with a goal of maintaining 180 min/week of low- to moderate-intensity exercise (e.g., walking and other aerobic activities, 4-6 days per week). Three of the weekly exercise sessions will be supervised and 1-3 will be unsupervised. Subjects will be asked to wear a pedometer and record their daily physical activity (steps) each night in a physical activity diary. Diaries will be collected at each visit and used to evaluate exercise compliance. Dual energy X-ray absorptiometry (DEXA) and computed tomography (CT) scans will be performed at baseline (week 0) and at the end of the treatment (week 12). Additionally, body weight and abdominal circumference will be assessed at every clinic visit during the study. It is anticipated that subjects will expend 1000-1800 kcal per week above their baseline level in deliberate physical activity. Accordingly, the control group is expected to lose 1.5 to 2.8 kg of body fat during the 12-week treatment period
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | – | Dietary Supplement: 500 mL/day of a beverage providing approximately 625 mg catechinsTea catechin sport beverage |
| Control | – | Other: Control beverage matched for energy and caffeine contentControl beverage |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 500 mL/day of a beverage providing approximately 625 mg catechinsSubjects were asked to consume 500 mL/day of a beverage providing approximately 625 mg catechins | Dietary supplement | Active |
| Control beverage matched for energy and caffeine content500 mL/day of a control beverage | Other | Control |
Primary outcome
Changes in body fat mass.
Time frame: Baseline to end-of-treatment
1 secondary outcome
Changes in body weight
Time frame: Baseline to end-of-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2008.
- Background: PubMed 12439647Murase 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.
- Background: PubMed 10584049Dulloo 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.
- Background: PubMed 15640470Nagao 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.
- Background: PubMed 17557985Nagao 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin C Maki, PhD study director
Provident Clinical Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overweight and Obesity, run by Provident Clinical Research at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in body fat mass. (time frame: Baseline to end-of-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00692731, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2008.