OverweightPhase 2NCT00825838
Effect of Chili Pepper Extract on Weight and Fat Loss and Metabolism Increase
A Phase 2 study testing Chronic consumption of chili pepper extract in people with Overweight and Obesity, run by Ajinomoto USA, INC..
Trial summary
The purpose of this study is to test the safety and effectiveness of a purified extract of CH-19 Sweet, containing capsinoids. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Chronic consumption of chili pepper extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Apr 2006to Mar 2007
- 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 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Is overweight or obese but otherwise generally healthy who interested in losing weight
- BMI of 25 to 35 kg/m2
- Waist/hip ratio of 0.9 or more for male and 0.85 for female.
Who cannot join
- Type 1 or 2 diabetes mellitus
- cardiovascular disease (other than mild, controlled hypertension or dislidemia)
- On a weight-loss program within six months
About this study
Official title: A Randomized Double-Blind Placebo-Controlled Clinical Trial of a Purified Chili Pepper Extract (CH-19 Sweet Extract) to Evaluate Its Safety and Efficacy for Weight and Fat Loss and Metabolism Change in Overweight or Obese Healthy Male and Female Adults
The purpose of this study is to test the safety and effectiveness of a purified extract of CH-19 Sweet, containing capsinoids.
- Conditions
- Overweight, Obesity
- Being tested
- Chronic consumption of chili pepper extract, Chronic consumption of matching placebo
- Keywords
- Body weight, Body composition, Resting metabolic rate and fat oxidation in men, class I obese
- Medical subject headings
- Overweight, Obesity, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chronic consumption of chili pepper extractDietary supplement
6mg chili pepper extract per day in two divided doses (before the morning meal and before the evening meal) up to 12 weeks.
Chronic consumption of matching placeboDietary supplement
0mg chili pepper extract (matching placebo) per day in two divided doses (before the morning meal and before the evening meal) up to 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Oral ingestion of 6mg chili pepper extract Receives: Dietary Supplement: Chronic consumption of chili pepper extract |
| 2 | Placebo comparator | Oral ingestion of 0 mg chili pepper extract (matching placebo) Receives: Dietary Supplement: Chronic consumption of matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
body weight and body composition
Measured: 12 weeks
Secondary outcomes (1)
resting metabolic rate and substrate oxidation
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2009 (estimated)
- Study startApr 2006
- Primary completionOct 2006
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajinomoto USA, INC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Soren Snitker, M.D., Ph.D., Study chair, University of Maryland, BaltimoreYoshiyuki Fujishima, D. Phil., Study director, Ajinomoto USA, INC.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00825838
- Sponsor's protocol ID
- CH19-001
- Status last verified
- Jan 2009
- First submitted
- 18 Jan 2009
- Last updated
- 21 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-Blind Placebo-Controlled Clinical Trial of a Purified Chili Pepper Extract (CH-19 Sweet Extract) to Evaluate Its Safety and Efficacy for Weight and Fat Loss and Metabolism Change in Overweight or Obese Healthy Male and Female Adults
- ClinicalTrials.gov ID
- NCT00825838
- Acronym / sponsor ID
- CH19-001
- Conditions
- Overweight, Obesity
- Keywords
- Body weight, Body composition, Resting metabolic rate and fat oxidation in men, class I obese
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ajinomoto USA, INC.Industry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Oct 2006 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 21 Jan 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 purpose of this study is to test the safety and effectiveness of a purified extract of CH-19 Sweet, containing capsinoids.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Chronic consumption of chili pepper extractOral ingestion of 6mg chili pepper extract |
| 2 | Placebo comparator | Dietary Supplement: Chronic consumption of matching placeboOral ingestion of 0 mg chili pepper extract (matching placebo) |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Is overweight or obese but otherwise generally healthy who interested in losing weight
- BMI of 25 to 35 kg/m2
- Waist/hip ratio of 0.9 or more for male and 0.85 for female.
Key exclusion criteria (3 listed)
- Type 1 or 2 diabetes mellitus
- cardiovascular disease (other than mild, controlled hypertension or dislidemia)
- On a weight-loss program within six months
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 |
|---|---|---|
| Chronic consumption of chili pepper extract6mg chili pepper extract per day in two divided doses (before the morning meal and before the evening meal) up to 12 weeks. | Dietary supplement | 1 |
| Chronic consumption of matching placebo0mg chili pepper extract (matching placebo) per day in two divided doses (before the morning meal and before the evening meal) up to 12 weeks. | Dietary supplement | 2 |
Primary outcome
body weight and body composition
Time frame: 12 weeks
1 secondary outcome
resting metabolic rate and substrate oxidation
Time frame: 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 21 Jan 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.
Soren Snitker, M.D., Ph.D. study chair
University of Maryland, Baltimore
Yoshiyuki Fujishima, D. Phil. study director
Ajinomoto USA, INC.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chronic consumption of chili pepper extract in people with Overweight and Obesity, run by Ajinomoto USA, INC..
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 3 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 21 Jan 2009. 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?
body weight and body composition (time frame: 12 weeks). 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 21 Jan 2009.