ObesityNCT00867555
Green Tea, High in Epigallocatechin Gallate (EGCG) and Postprandial Fat Oxidation
A study testing Effect of the green tea extract TEAVIGO, high in EGCG, on postprandial fat oxidation in people with Obesity and Type 2 Diabetes Mellitus, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The body of evidence regarding the health benefits of green tea has grown considerably during the last decade and includes antioxidant properties, anti- cancer, anti-obesity and anti-diabetes effects. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Type 2 Diabetes Mellitus
- What is being tested?
- Effect of the green tea extract TEAVIGO, high in EGCG, on postprandial fat oxidation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2008to May 2009
- Phase
- Interventional
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 20 and 50 y
- BMI 25.0-29.9 kg/m2
- Normal fasting glucose <6.1 mmol/L
- Blood pressure (systolic blood pressure 100-150 mmHg, diastolic blood pressure 60-90 mmHg)
- Weight stable in last 3 months (±2 kg)
Who cannot join
- pregnant, lactating or (post)menopausal women
- regular smokers
- people with intensive fitness training eg athletes
- habitual consumption of green or black tea (more than 1 or 2 cups a day, respectively)
- not more than 300 mg/day caffeine consumption
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Dept Human Biology, Maastricht University
Maastricht, 6200 MD
About this study
Official title: Effects of the Green Tea Extract TEAVIGO High in EGCG, on Postprandial Fat Oxidation in Overweight Volunteers
The body of evidence regarding the health benefits of green tea has grown considerably during the last decade and includes antioxidant properties, anti- cancer, anti-obesity and anti-diabetes effects. There has been evidence that green tea extract favorably affect body weight and body fat and has positive effects on blood glucose control
Aim of this study is to investigate the short term effect (3-day)of TEAVIGO (high in the catechin EGCG) on postprandial fat oxidation during different phases of the postprandial period in overweight subjects. Secondly, in a subset of volunteers changes in lipolysis and glucose metabolism will be studied in skeletal muscle and adipose tissue.
- Conditions
- Obesity, Type 2 Diabetes Mellitus
- Being tested
- Effect of the green tea extract TEAVIGO, high in EGCG, on postprandial fat oxidation
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effect of the green tea extract TEAVIGO, high in EGCG, on postprandial fat oxidationDietary supplement
green tea extract TEAVIGO, high in EGCG
| Study group | Role | What they receive |
|---|---|---|
| EGCG | Experimental | Double blind randomized, placebo-controlled cross-over design with two arms:
* the green tea extract TEAVIGO, high in EGCG and
* placebo Receives: Dietary Supplement: Effect of the green tea extract TEAVIGO, high in EGCG, on postprandial fat oxidation |
| placebo | Placebo comparator | Not described Receives: Dietary Supplement: Effect of the green tea extract TEAVIGO, high in EGCG, on postprandial fat oxidation |
What is being measured
The primary outcome is the main question the study is designed to answer.
postprandial fat oxidation
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2009 (estimated)
- Study startOct 2008
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- dsm-firmenich Switzerland AG
- Investigators
- Ellen E Blaak, PhD, Prof, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00867555
- Sponsor's protocol ID
- MEC 08-3-052
- Status last verified
- Sep 2009
- First submitted
- 23 Mar 2009
- Last updated
- 18 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Green Tea Extract TEAVIGO High in EGCG, on Postprandial Fat Oxidation in Overweight Volunteers
- ClinicalTrials.gov ID
- NCT00867555
- Acronym / sponsor ID
- MEC 08-3-052
- Conditions
- Obesity, Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- dsm-firmenich Switzerland AG
- Study start
- Oct 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 24 Mar 2009 (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 body of evidence regarding the health benefits of green tea has grown considerably during the last decade and includes antioxidant properties, anti- cancer, anti-obesity and anti-diabetes effects. There has been evidence that green tea extract favorably affect body weight and body fat and has positive effects on blood glucose control
Aim of this study is to investigate the short term effect (3-day)of TEAVIGO (high in the catechin EGCG) on postprandial fat oxidation during different phases of the postprandial period in overweight subjects. Secondly, in a subset of volunteers changes in lipolysis and glucose metabolism will be studied in skeletal muscle and adipose tissue.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EGCG | Experimental | Dietary Supplement: Effect of the green tea extract TEAVIGO, high in EGCG, on postprandial fat oxidationDouble blind randomized, placebo-controlled cross-over design with two arms: * the green tea extract TEAVIGO, high in EGCG and * placebo |
| placebo | Placebo comparator | Dietary Supplement: Effect of the green tea extract TEAVIGO, high in EGCG, on postprandial fat oxidation |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age between 20 and 50 y
- BMI 25.0-29.9 kg/m2
- Normal fasting glucose <6.1 mmol/L
- Blood pressure (systolic blood pressure 100-150 mmHg, diastolic blood pressure 60-90 mmHg)
- Weight stable in last 3 months (±2 kg)
Key exclusion criteria (5 listed)
- pregnant, lactating or (post)menopausal women
- regular smokers
- people with intensive fitness training eg athletes
- habitual consumption of green or black tea (more than 1 or 2 cups a day, respectively)
- not more than 300 mg/day caffeine consumption
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 |
|---|---|---|
| Effect of the green tea extract TEAVIGO, high in EGCG, on postprandial fat oxidationgreen tea extract TEAVIGO, high in EGCG | Dietary supplement | EGCG, placebo |
Primary outcome
postprandial fat oxidation
Time frame: 8 months
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 18 Sep 2009.
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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.
Ellen E Blaak, PhD, Prof principal investigator
Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Effect of the green tea extract TEAVIGO, high in EGCG, on postprandial fat oxidation in people with Obesity and Type 2 Diabetes Mellitus, run by Maastricht University Medical Center at 1 site in Netherlands.
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 5 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 18 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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. Some participants in this study may receive a placebo. 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?
postprandial fat oxidation (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Sep 2009.