ObesityNCT03537625
Effects of Green Tea on Body Weight Reduction and Gut Microbiota
A study testing Green tea in people with Obesity, run by Seoul National University Hospital.
Trial summary
The investigators randomly assigned green tea extract, fermented green tea extract, or placebo in adult subjects whose BMI was 25-35 kg/m2. Participants were 40 in each group, and treatment duration was 12 weeks. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Green tea
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 20 Mar 2016to 13 Apr 2018
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 20-60 years
- BMI 25-35 kg/m2
- Abdominal obesity (Waist circumference): Male >90 cm, Female >85cm
Who cannot join
- Cardiovascular events within 3 months
- uncontrolled hypertension (>160/100 mmHg)
- Diabetes mellitus
- Dyslipidemia under statin therapy
- TSH<0.1 uU/ml or>10 uU/ml
- Elevated creatinine level (twice higher than upper normal limit)
- Elevated AST/ALT level (three times higher than upper normal limit)
- Pregnancy, lactation
About this study
Official title: Effects of Green Tea and Fermented Green Tea Extract on Obese Adults: a Randomized Double-blind, Placebo-controlled Study Focused on Change of Gut Microbiota and Inflammatory Markers
The investigators randomly assigned green tea extract, fermented green tea extract, or placebo in adult subjects whose BMI was 25-35 kg/m2. Participants were 40 in each group, and treatment duration was 12 weeks. Primary outcomes were body weight change and fat mass change from baseline to 12 weeks, and secondary outcomes were metabolic parameteres and gut microbiota.
Read the detailed description
After screening obese subjects who met the inclusion and exclusion criteria, the investigators randomly assigned the two treatment arms and one placebo arm at 1:1:1 ratio. At baseline, anthropometric and biochemical evaluations were conducted including body weight, body composition (DXA and Fat CT), lipid profiles, and liver function test. The tablets were supplied to each participants under double-blind conditions. The investigators obtained blood and stool samples both baseline and final visit at 12 weeks. For improving compliance for treatments, the investigators checked diary for lifestyle and drug compliance every 6 week.
- Conditions
- Obesity
- Being tested
- Green tea
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Green teaDietary supplement
We made a dietary supplement from Cammellia sinesis O. Kunze, and made tablets containing extract.
| Study group | Role | What they receive |
|---|---|---|
| Green tea | Experimental | Green tea extract 2 gram per day Receives: Dietary Supplement: Green tea |
| Fermented green tea | Experimental | Fermented green tea extract 2 gram per day Receives: Dietary Supplement: Green tea |
| Placebo | Placebo comparator | Placebo Receives: Dietary Supplement: Green tea |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Body weight change were calculated using electronic scale
Measured: Baseline, and 12 weeks
Body fat
Total body fat change were calculated using DXA and abdominal fat CT
Measured: Baseline, and 12 weeks
Secondary outcomes (4)
Waist circumference
Waist circumference was measured using standard method
Measured: Baseline, 6 weeks, and 12 weeks
Lipid profile
total cholesterol, TG, HDL-C, LDL-C, TG/HDL-C, Apo B/ApoA1, Apo B, Apo A1
Measured: Baseline, and 12 weeks
Inflammatory markers
hs-CRP, ESR, inflammatory cytokines (TNFa, IL-1β, IL-6)
Measured: Baseline, and 12 weeks
Microbiota
Gut Microbiota composition
Measured: Baseline, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2018
- Study start20 Mar 2016
- Primary completion13 Apr 2018
- Study completion13 Apr 2018
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 Seoul National University HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Amorepacific Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03537625
- Sponsor's protocol ID
- SNUBH-GT
- Status last verified
- Apr 2018
- First submitted
- 16 Apr 2018
- Last updated
- 25 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Green Tea and Fermented Green Tea Extract on Obese Adults: a Randomized Double-blind, Placebo-controlled Study Focused on Change of Gut Microbiota and Inflammatory Markers
- ClinicalTrials.gov ID
- NCT03537625
- Acronym / sponsor ID
- SNUBH-GT
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Amorepacific Corporation
- Study start
- 20 Mar 2016 (actual)
- Primary completion
- 13 Apr 2018 (actual)
- Study completion
- 13 Apr 2018 (actual)
- First posted
- 25 May 2018 (actual)
- 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 investigators randomly assigned green tea extract, fermented green tea extract, or placebo in adult subjects whose BMI was 25-35 kg/m2. Participants were 40 in each group, and treatment duration was 12 weeks. Primary outcomes were body weight change and fat mass change from baseline to 12 weeks, and secondary outcomes were metabolic parameteres and gut microbiota.
Detailed description
After screening obese subjects who met the inclusion and exclusion criteria, the investigators randomly assigned the two treatment arms and one placebo arm at 1:1:1 ratio. At baseline, anthropometric and biochemical evaluations were conducted including body weight, body composition (DXA and Fat CT), lipid profiles, and liver function test. The tablets were supplied to each participants under double-blind conditions. The investigators obtained blood and stool samples both baseline and final visit at 12 weeks. For improving compliance for treatments, the investigators checked diary for lifestyle and drug compliance every 6 week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Green tea | Experimental | Dietary Supplement: Green teaGreen tea extract 2 gram per day |
| Fermented green tea | Experimental | Dietary Supplement: Green teaFermented green tea extract 2 gram per day |
| Placebo | Placebo comparator | Dietary Supplement: Green teaPlacebo |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 20-60 years
- BMI 25-35 kg/m2
- Abdominal obesity (Waist circumference): Male >90 cm, Female >85cm
Key exclusion criteria (8 listed)
- Cardiovascular events within 3 months
- uncontrolled hypertension (>160/100 mmHg)
- Diabetes mellitus
- Dyslipidemia under statin therapy
- TSH<0.1 uU/ml or>10 uU/ml
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 |
|---|---|---|
| Green teaWe made a dietary supplement from Cammellia sinesis O. Kunze, and made tablets containing extract. | Dietary supplement | Fermented green tea, Green tea, Placebo |
Primary outcome
Body weight
Time frame: Baseline, and 12 weeks
Body weight change were calculated using electronic scale
Body fat
Time frame: Baseline, and 12 weeks
Total body fat change were calculated using DXA and abdominal fat CT
4 secondary outcomes
Waist circumference
Time frame: Baseline, 6 weeks, and 12 weeks
Lipid profile
Time frame: Baseline, and 12 weeks
Inflammatory markers
Time frame: Baseline, and 12 weeks
Microbiota
Time frame: Baseline, and 12 weeks
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 25 May 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Green tea in people with Obesity, run by Seoul National University Hospital.
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 3 inclusion and 8 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 25 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Body weight (time frame: Baseline, and 12 weeks). The study lists 2 primary outcomes in all. 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 25 May 2018.