ObesityPhase 2NCT01778257
Efficacy and Safety of Mate Extracts on Decrement of Body and Abdominal Fat in Obese Subjects
A Phase 2 study testing Mate extract in people with Obesity, run by Chonbuk National University Hospital.
Trial summary
Obesity is a major health issue worldwide; there is a constant raise in obesity related death each year. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Mate extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2011to Mar 2012
- Phase
- Phase 2
- 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 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteers aged 19 to 65 years
- 25 kg/m2 ≤ BMI ≥35 kg/m2
- Ability to give informed consent
Who cannot join
- Significant variation in weight (more 10%) in the past 3 month
- Cardiovascular disease, neurologic or psychiatric disease, renal, pulmonary and hepatic abnormalities
- History of disease that could interfere with the test products or impede their absorption, such as gastrointestinal disease (Crohn's disease) or gastrointestinal surgery (a caesum or enterocele surgery are included)
- Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the sutdy
- Allergic or hypersensitive to any of the ingredients in the test products
- Pregnancy or breast feeding
Show all 9Show fewer
- Used antipsychosis drugs therapy within past 2 months
- History of alcohol or substance abuse (21 units/week over)
- Participation in any other clinical trials within past 3 months
About this study
Official title: Mate Extract Supplementation Reduces Body and Abdominal Fat in Obese Korean Subjects
Obesity is a major health issue worldwide; there is a constant raise in obesity related death each year.
Read the detailed description
The primary aim of the study was to investigate the effect of Mate extracts in Korean subjects on body fat and abdominal fat, double blind, placebo-controlled clinical trial.
Thirty obesity subjects with BMI ≥ 25 kg/㎡ and waist-hip ratio (WHR)≥ 0.90 for men and ≥ 0.85 for women were for 12 weeks.
- Conditions
- Obesity
- Being tested
- Mate extract, Placebo
- Keywords
- Mate extracts, Obesity, abdominal fat
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mate extractDietary supplement
Also called Extracts of Ilex paraguariensis A. St.-Hil.
Mate is a South American herb that is traditionally prepared as a tea and used, among others, for weight reduction.
PlaceboDietary supplement
Amount and calorie of placebo are same with Mate extracts.
| Study group | Role | What they receive |
|---|---|---|
| Mate extracts group | Experimental | Mate extract(3150 mg/day)for 12 weeks Receives: Dietary Supplement: Mate extract |
| Placebo group | Placebo comparator | Placebo (3150 mg/day) for 12 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in body and abdominal fat
Measured: body fat: baseline, 6 weeks and 12 weeks, abdominal fat of CT: baseline and 12 weeks
Secondary outcomes (2)
Changes in anthropometric parameters(weight, BMI, waist and hip circumference)
Measured: baseline, 6 weeks and 12 weeks
Changes in blood lipid profile(total cholesterol, triglyceride, HDL-cholesterol, LDL-cholesterol, free fatty acid)
Measured: baseline, 6 weeks 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 posted29 Jan 2013 (estimated)
- Study startOct 2011
- Primary completionFeb 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonbuk National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- GS Engineering & Construction
- Responsible party
- Principal investigator, Min-Gul Kim, MD, Chonbuk National University Hospital
- Investigators
- Min-Gul Kim, MD, Principal investigator, Chonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01778257
- Sponsor's protocol ID
- CUH_2011_GS_MATE
- Status last verified
- Jan 2013
- First submitted
- 7 Dec 2012
- Last updated
- 29 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kim SY, Oh MR, Kim MG, Chae HJ, Chae SW. Anti-obesity effects of Yerba Mate (Ilex Paraguariensis): a randomized, double-blind, placebo-controlled clinical trial. BMC Complement Altern Med. 2015 Sep 25;15:338. doi: 10.1186/s12906-015-0859-1.
PubMed 26408319
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mate Extract Supplementation Reduces Body and Abdominal Fat in Obese Korean Subjects
- ClinicalTrials.gov ID
- NCT01778257
- Acronym / sponsor ID
- CUH_2011_GS_MATE
- Conditions
- Obesity
- Keywords
- Mate extracts, Obesity, abdominal fat
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chonbuk National University HospitalUniversity, hospital or other
- Collaborators
- GS Engineering & Construction
- Study start
- Oct 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 29 Jan 2013 (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.
Obesity is a major health issue worldwide; there is a constant raise in obesity related death each year.
Detailed description
The primary aim of the study was to investigate the effect of Mate extracts in Korean subjects on body fat and abdominal fat, double blind, placebo-controlled clinical trial.
Thirty obesity subjects with BMI ≥ 25 kg/㎡ and waist-hip ratio (WHR)≥ 0.90 for men and ≥ 0.85 for women were for 12 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mate extracts group | Experimental | Dietary Supplement: Mate extractMate extract(3150 mg/day)for 12 weeks |
| Placebo group | Placebo comparator | Dietary Supplement: PlaceboPlacebo (3150 mg/day) for 12 weeks |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Volunteers aged 19 to 65 years
- 25 kg/m2 ≤ BMI ≥35 kg/m2
- Ability to give informed consent
Key exclusion criteria (9 listed)
- Significant variation in weight (more 10%) in the past 3 month
- Cardiovascular disease, neurologic or psychiatric disease, renal, pulmonary and hepatic abnormalities
- History of disease that could interfere with the test products or impede their absorption, such as gastrointestinal disease (Crohn's disease) or gastrointestinal surgery (a caesum or enterocele surgery are included)
- Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the sutdy
- Allergic or hypersensitive to any of the ingredients in the test products
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 |
|---|---|---|
| Mate extractAlso: Extracts of Ilex paraguariensis A. St.-Hil.Mate is a South American herb that is traditionally prepared as a tea and used, among others, for weight reduction. | Dietary supplement | Mate extracts group |
| PlaceboAmount and calorie of placebo are same with Mate extracts. | Dietary supplement | Placebo group |
Primary outcome
Changes in body and abdominal fat
Time frame: body fat: baseline, 6 weeks and 12 weeks, abdominal fat of CT: baseline and 12 weeks
2 secondary outcomes
Changes in anthropometric parameters(weight, BMI, waist and hip circumference)
Time frame: baseline, 6 weeks and 12 weeks
Changes in blood lipid profile(total cholesterol, triglyceride, HDL-cholesterol, LDL-cholesterol, free fatty acid)
Time frame: baseline, 6 weeks 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 29 Jan 2013.
- Derived from this study: PubMed 26408319Kim SY, Oh MR, Kim MG, Chae HJ, Chae SW. Anti-obesity effects of Yerba Mate (Ilex Paraguariensis): a randomized, double-blind, placebo-controlled clinical trial. BMC Complement Altern Med. 2015 Sep 25;15:338. doi: 10.1186/s12906-015-0859-1.
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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.
Min-Gul Kim, MD principal investigator
Chonbuk National University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mate extract in people with Obesity, run by Chonbuk 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 9 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 29 Jan 2013. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 and abdominal fat (time frame: body fat: baseline, 6 weeks and 12 weeks, abdominal fat of CT: baseline and 12 weeks). 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 NCT01778257, which also lists 1 linked publication.
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 29 Jan 2013.