ObesityNCT01773356
Effect of Dihydrocapsiate on Energy Expenditure in Women
A study testing Dihydrocapsiate in people with Obesity, run by Ellen Evans at 1 site in United States.
Trial summary
The objective of this study is to test the effect of dihydrocapsiate on energy expenditure in women. Read more about this study
- Who is it for?
- Ages 25 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Dihydrocapsiate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Mar 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 25 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI: 18.5-34.5 kg/m2
- Good general health
- Low to mild physical activity
- Willing to maintain habitual diet and physical activity patterns throughout the study period
- Premenopausal and cycling regularly or using oral contraceptives
- Willing to attend study visits only during the follicular phase or bleed phase of their menstrual cycle
- Understands study procedures and signs forms providing informed consent to participate in the study
- Have spoken and written English literacy
Who cannot join
- Diabetes mellitus or any conditions that might affect energy metabolism
- Weight change ±2 kg over previous three months
- Known sensitivity or allergy to ingredients of the study products
- Non-breakfast eater
- Recent use of antibiotics
- History of smoking during the six months prior to study
Show all 14Show fewer
- Recent signs or symptoms of infection, including cold or flu-like symptoms
- Concurrent or recent intervention study participation
- Instability in breathing patterns or energy expenditure measures
- History of drug or alcohol abuse
- Lipid-lowering, anti-hypertensive or anti-inflammatory steroid medication use
- Weight loss medication
- Pregnant or lactating
- Unwilling to be randomized to any experimental group and unable to meet all requirements of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Georgia, Department of Kinesiology
Athens, Georgia, 30602-6554
About this study
Official title: Randomized, Controlled, Parallel Trial to Evaluate the Effects of Dihydrocapsiate on Energy Expenditure in Women
The objective of this study is to test the effect of dihydrocapsiate on energy expenditure in women.
Read the detailed description
Capsaicin, a substance found in chili pepper, is known to stimulate thermogenesis. Dihydrocapsiate, a capsinoid, found in the non-pungent CH-19 sweet pepper has similar thermogenic effects without the gastrointestinal side effects. The objective of this project is to test the effect of 12 weeks of daily consumption of 9 mg dihydrocapsiate on resting energy expenditure relative to baseline when compared to a control group consuming products without DCT.
- Conditions
- Obesity
- Being tested
- Dihydrocapsiate
- Keywords
- Obesity, Body Weight, Body Composition, Metabolism, Resting Energy Expenditure
- 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.
DihydrocapsiateDietary supplement
Also called Natural substances present in sweet chili peppers
Kellogg's ready to eat cereal, cereal bars, and crackers will contain dihyrocapsiate or placebo. Daily consumption of dihydrocapsiate is 9mg/d or 0mg/d.
| Study group | Role | What they receive |
|---|---|---|
| Placebo 0 mg/d | Placebo comparator | 0 mg/d of Dihydrocapsiate will be consumed in ready to ear cereal, cereal bars or crackers Receives: Dietary Supplement: Dihydrocapsiate |
| Dihydrocapsiate 9 mg/d | Active comparator | 9 mg/d of Dihydrocapsiate will be consumed in ready to ear cereal, cereal bars or crackers Receives: Dietary Supplement: Dihydrocapsiate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting Energy Expenditure
Measured: Change from Baseline at 12 weeks
Secondary outcomes (2)
Thermic effect of feeding
Measured: Change from baseline at 12 weeks
Body Composition
Measured: Change from baseline at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2013 (estimated)
- Study startJan 2011
- Primary completionMar 2014
- Study completionMar 2014
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.
- 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
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ellen Evans
- Sponsor type
- University, hospital or other
- Collaborators
- Kellogg Company
- Responsible party
- Sponsor-investigator, Ellen Evans, University of Georgia
- Investigators
- Ellen M Evans, Ph.D., Principal investigator, University of Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01773356
- Sponsor's protocol ID
- WASABI
- Status last verified
- Sep 2015
- First submitted
- 15 Jan 2013
- Last updated
- 25 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled, Parallel Trial to Evaluate the Effects of Dihydrocapsiate on Energy Expenditure in Women
- ClinicalTrials.gov ID
- NCT01773356
- Acronym / sponsor ID
- WASABI
- Conditions
- Obesity
- Keywords
- Obesity, Body Weight, Body Composition, Metabolism, Resting Energy Expenditure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Ellen EvansUniversity, hospital or other
- Collaborators
- Kellogg Company
- Study start
- Jan 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 23 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.
The objective of this study is to test the effect of dihydrocapsiate on energy expenditure in women.
Detailed description
Capsaicin, a substance found in chili pepper, is known to stimulate thermogenesis. Dihydrocapsiate, a capsinoid, found in the non-pungent CH-19 sweet pepper has similar thermogenic effects without the gastrointestinal side effects. The objective of this project is to test the effect of 12 weeks of daily consumption of 9 mg dihydrocapsiate on resting energy expenditure relative to baseline when compared to a control group consuming products without DCT.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo 0 mg/d | Placebo comparator | Dietary Supplement: Dihydrocapsiate0 mg/d of Dihydrocapsiate will be consumed in ready to ear cereal, cereal bars or crackers |
| Dihydrocapsiate 9 mg/d | Active comparator | Dietary Supplement: Dihydrocapsiate9 mg/d of Dihydrocapsiate will be consumed in ready to ear cereal, cereal bars or crackers |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- BMI: 18.5-34.5 kg/m2
- Good general health
- Low to mild physical activity
- Willing to maintain habitual diet and physical activity patterns throughout the study period
- Premenopausal and cycling regularly or using oral contraceptives
Key exclusion criteria (14 listed)
- Diabetes mellitus or any conditions that might affect energy metabolism
- Weight change ±2 kg over previous three months
- Known sensitivity or allergy to ingredients of the study products
- Non-breakfast eater
- Recent use of antibiotics
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 sweet chili peppersKellogg's ready to eat cereal, cereal bars, and crackers will contain dihyrocapsiate or placebo. Daily consumption of dihydrocapsiate is 9mg/d or 0mg/d. | Dietary supplement | Dihydrocapsiate 9 mg/d, Placebo 0 mg/d |
Primary outcome
Resting Energy Expenditure
Time frame: Change from Baseline at 12 weeks
2 secondary outcomes
Thermic effect of feeding
Time frame: Change from baseline at 12 weeks
Body Composition
Time frame: Change from baseline at 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 Sep 2015.
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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 M Evans, Ph.D. principal investigator
University of Georgia
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, run by Ellen Evans 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 8 inclusion and 14 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 Sep 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?
Resting Energy Expenditure (time frame: Change from Baseline at 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 25 Sep 2015.