ObesityCAPSPALNCT00999297
Effect of 4-week Dihydrocapsiate Ingestion on Resting Metabolic Rate
A study testing Dihydrocapsiate in people with Obesity and Weight, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
A 4 week intake of drug to find a natural substance that may modify energy balance and may enhance health in combination with lifestyle changes with possible decrease in body weight. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- What is being tested?
- Dihydrocapsiate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Dec 2014
- 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
- Men between 20-60 years old
- Healthy as assessed by medical history and standard medical exam
- Weight-stable
- Body mass index of 25 to 34.9 kg/m2
- Non-smoker
- Sedentary lifestyle: not being physically active grater than 3 days/week for 20 min each time for the previous 6 months, and not participating in regular resistance exercise.
Who cannot join
- Subjects enrolled in a diet to increase or decrease body weight
- Special diet or food aversiions to common foods
- Has allergy to chilli pepper
- Eating chilli peppers on a daily basis
- Usually consuming more than 2 cups of tea or coffee/day
- Usually consuming more than 4 cans of caffeinated soft drinks a day
Show all 11Show fewer
- Usually consuming more than 3 standard alcohol drinks/day
- Regular use of medications (weight loss drugs, drugs affecting energy metabolism, drugs for depression)
- Usual intake of illicit substances
- Claustrophobia
- Participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70809
About this study
Official title: Effect of 4-week Dihydrocapsiate Ingestion on Resting Metabolic Rate: A Double-blind Randomized Parallel Arm Study
A 4 week intake of drug to find a natural substance that may modify energy balance and may enhance health in combination with lifestyle changes with possible decrease in body weight.
Read the detailed description
This study is a double-blind, placebo-controlled, single center, randomized, parallel arm clinical trial to test the impact of Dihydrocapsiate (placebo, 3 and 9 mg/d) ingested for 4 weeks on resting metabolic rate and fat oxidation measured by indirect calorimetry.
- Being tested
- Dihydrocapsiate
- Keywords
- thermogenesis, respiratory quotient, fat oxidation
- Medical subject headings
- Obesity, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DihydrocapsiateOther
Also called Natural Substances present in chili pepper
Capsules will contain dihydrocapsiate 3 mg/d or 9 mg/d or placebo
DihydrocapsiateOther
Also called Natural Substances present in chili pepper
Capsules will contain dihydrocapsiate 3 mg/d or 9 mg/d or placebo
DihydrocapsiateOther
Also called Natural Substances present in chili pepper
Capsules will contain dihydrocapsiate 3 mg/d or 9 mg/d or placebo
| Study group | Role | What they receive |
|---|---|---|
| Sugar pill (Placebo o mg/d) | Placebo comparator | 0 mg/d sugar pill Receives: Other: Dihydrocapsiate |
| Dihydrocapsiate | Active comparator | Drug 3 mg/d or 9 mg/d including Placebo Receives: Other: Dihydrocapsiate |
| 3 mg/d or 9 mg/d Dihydrocapsiate | Active comparator | Drug including Placebo Receives: Other: Dihydrocapsiate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The consumption of dihydrocapsiate will significantly increase resting energy expenditure and fat oxidation
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2009 (estimated)
- Study startJul 2008
- Primary completionNov 2009
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ajinomoto USA, INC.
- Responsible party
- Principal investigator, Eric Ravussin, Pennington Biomedical Research Center
- Investigators
- Eric Ravussin, PhD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00999297
- Sponsor's protocol ID
- PBRC 28016
- Other IDs
- PBRC28016
- Acronym
- CAPSPAL
- Status last verified
- Nov 2015
- First submitted
- 20 Oct 2009
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Galgani JE, Ryan DH, Ravussin E. Effect of capsinoids on energy metabolism in human subjects. Br J Nutr. 2010 Jan;103(1):38-42. doi: 10.1017/S0007114509991358. Epub 2009 Aug 12.
PubMed 19671203Galgani JE, Ravussin E. Effect of dihydrocapsiate on resting metabolic rate in humans. Am J Clin Nutr. 2010 Nov;92(5):1089-93. doi: 10.3945/ajcn.2010.30036. Epub 2010 Sep 8.
PubMed 20826626
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 4-week Dihydrocapsiate Ingestion on Resting Metabolic Rate: A Double-blind Randomized Parallel Arm Study
- ClinicalTrials.gov ID
- NCT00999297
- Acronym / sponsor ID
- CAPSPAL / PBRC 28016
- Keywords
- thermogenesis, respiratory quotient, fat oxidation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- Ajinomoto USA, INC.
- Study start
- Jul 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 21 Oct 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.
A 4 week intake of drug to find a natural substance that may modify energy balance and may enhance health in combination with lifestyle changes with possible decrease in body weight.
Detailed description
This study is a double-blind, placebo-controlled, single center, randomized, parallel arm clinical trial to test the impact of Dihydrocapsiate (placebo, 3 and 9 mg/d) ingested for 4 weeks on resting metabolic rate and fat oxidation measured by indirect calorimetry.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sugar pill (Placebo o mg/d) | Placebo comparator | Other: Dihydrocapsiate0 mg/d sugar pill |
| Dihydrocapsiate | Active comparator | Other: DihydrocapsiateDrug 3 mg/d or 9 mg/d including Placebo |
| 3 mg/d or 9 mg/d Dihydrocapsiate | Active comparator | Other: DihydrocapsiateDrug including Placebo |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Men between 20-60 years old
- Healthy as assessed by medical history and standard medical exam
- Weight-stable
- Body mass index of 25 to 34.9 kg/m2
- Non-smoker
Key exclusion criteria (11 listed)
- Subjects enrolled in a diet to increase or decrease body weight
- Special diet or food aversiions to common foods
- Has allergy to chilli pepper
- Eating chilli peppers on a daily basis
- Usually consuming more than 2 cups of tea or coffee/day
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 |
|---|---|---|
| DihydrocapsiateAlso: Natural Substances present in chili pepperCapsules will contain dihydrocapsiate 3 mg/d or 9 mg/d or placebo | Other | Sugar pill (Placebo o mg/d) |
| DihydrocapsiateAlso: Natural Substances present in chili pepperCapsules will contain dihydrocapsiate 3 mg/d or 9 mg/d or placebo | Other | Dihydrocapsiate |
| DihydrocapsiateAlso: Natural Substances present in chili pepperCapsules will contain dihydrocapsiate 3 mg/d or 9 mg/d or placebo | Other | 3 mg/d or 9 mg/d Dihydrocapsiate |
Primary outcome
The consumption of dihydrocapsiate will significantly increase resting energy expenditure and fat oxidation
Time frame: 4 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 20 Nov 2015.
- Results publication: PubMed 19671203Galgani JE, Ryan DH, Ravussin E. Effect of capsinoids on energy metabolism in human subjects. Br J Nutr. 2010 Jan;103(1):38-42. doi: 10.1017/S0007114509991358. Epub 2009 Aug 12.
- Derived from this study: PubMed 20826626Galgani JE, Ravussin E. Effect of dihydrocapsiate on resting metabolic rate in humans. Am J Clin Nutr. 2010 Nov;92(5):1089-93. doi: 10.3945/ajcn.2010.30036. Epub 2010 Sep 8.
- Effect of capsinoids on energy metabolism in human subjectsLink provided by the sponsor.
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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.
Eric Ravussin, PhD principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dihydrocapsiate in people with Obesity and Weight, run by Pennington Biomedical Research Center at 1 site 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 6 inclusion and 11 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 20 Nov 2015. 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 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. 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?
The consumption of dihydrocapsiate will significantly increase resting energy expenditure and fat oxidation (time frame: 4 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 NCT00999297, which also lists 2 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 20 Nov 2015.