HealthyNCT01142687
Effects of Dihydrocapsiate on Adaptive and Diet-Induced Thermogenesis With a High Protein Very Low Calorie Diet
A study testing dihydrocapsiate capsule in people with Healthy, run by University of California, Los Angeles.
Trial summary
The study is designed to determine the effects of a non-pungent supplement from sweet chilli pepper on resting metabolic rate and diet-induced thermogenesis (DIT) after a period of very low calorie intake over 4 weeks. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- dihydrocapsiate capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- Nov 2008to Aug 2009
- 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal female or male over 30 years of age at the time the consent form is signed.
- Subject has a BMI between 27 and 35 kg/m2
- Subject is in good health based on history, physical examination, and basic laboratory studies.
- Consumes less than one alcoholic beverage per day
- Is a non-smoker for at least three months
- Willing to follow a Very Low Calorie Diet of 800 calories per day using meal replacements
- Ethical: Subject must sign the Institutional Review Board-approved written informed consent prior to the initiation of any study specific procedures or randomization. A subject will be excluded for any condition that might compromise the ability to give truly informed consent for participation in the study.
Who cannot join
- Any subject with known allergy to chili peppers by history.
- Any subject with type 2 diabetes or glucose intolerance
- Consumes more than one alcoholic beverage per day
- Any subject participating in regular vigorous exercises other than ordinary daily walks or who is unwilling to maintain their usual level of exercise during the study.
- Any subject with a diagnosed eating disorder or who is addicted to any medications.
- Any subject currently taking antidepressants or weight loss medication.
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- Any subjects with a history of gastrointestinal surgery, uncontrolled hypertension, or other serious medical condition, such as chronic hepatitis or renal disease, bleeding disorder, congestive heart disease, chronic diarrhea disorders, myocardial infarction, coronary artery bypass graft, angioplasty within 6 months prior to screening, current diagnosis of uncontrolled hypertension (defined as BP >160mmHg, diastolic BP>95mmHg), active or chronic gastrointestinal disorders, bulimia, anorexia, laxative abuse, or endocrine diseases (except thyroid disease requiring medication) as indicated by medical history or routine physical examination.
- Major surgery within 12 weeks prior to subject randomization and/or screening, especially cardiac surgery
- Is currently a smoker who has a therapeutic plan to quit smoking anytime during the study period; or if not a current smoker, has quit smoking within the past 3 months.
- Known HIV positive.
- Clinical evidence of current malignancy with the exception of basal cell or squamous cell carcinoma of the skin and cervical intraepithelial neoplasia.
- Currently receiving systemic chemotherapy and/or radiotherapy.
- Active bleeding.
- Subject has any disorder including illiteracy or visual impairment that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.
- In the opinion of the study investigator has a risk of non-compliance with study procedures, or cannot read, understand or complete study related materials.
About this study
Official title: Effects of Dihydrocapsiate on Adaptive and Diet-Induced Thermogenesis Following 4 Weeks of Very Low Calorie Diet
The study is designed to determine the effects of a non-pungent supplement from sweet chilli pepper on resting metabolic rate and diet-induced thermogenesis (DIT) after a period of very low calorie intake over 4 weeks.
Read the detailed description
Thirty-six subjects will be recruited by public advertisement. Postmenopausal women and men over age 30 with a body mass index (BMI) between 27 to 35 kg/m2,and in good health by history, physical examination, and basic laboratory screening (complete blood count, serum chemistries, liver panel, and lipid panel) will be selected for study. Subjects with type 2 diabetes or glucose intolerance will be excluded as will individuals who regularly drink more than one alcoholic beverage daily. Thirty-six men and women who meet the selection criteria below will be randomly assigned to one of three arms providing CH-19 at two dose levels per day vs. placebo capsules.
This will be a prospectively randomized double blind study in which neither the subjects nor the clinical research personnel will be aware of whether the subjects will be assigned to placebo or dihydrocapsiate at two different doses. A total of 36 subjects will be divided among three groups.
To keep the number of capsules taken by each subject constant, all subjects will take three capsules three times per day containing the appropriate number of active or placebo capsules and will be randomized after screening to one of three groups:
- Group 1: Dihydrocapsiate 1 capsule and 2 placebo capsules three times a day within 30 minutes before breakfast, lunch and dinner.
- Group 2: Dihydrocapsiate 3 capsules three times per day within 30 minutes before breakfast, lunch and dinner
- Group 3: Placebo 3 capsules three times per day within 30 minutes before breakfast, lunch and dinner
- Conditions
- Healthy
- Being tested
- dihydrocapsiate capsule
- Keywords
- Resting energy expenditure (REE), metabolic rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dihydrocapsiate capsuleDietary supplement
Also called chili pepper
- Group 1: 1 dihydrocapsiate capsule and 2 placebo capsules three times a day within 30 minutes before breakfast, lunch and dinner.
- Group 2: 3 dihydrocapsiate capsules three times per day within 30 minutes before breakfast, lunch and dinner
- Group 3: Placebo 3 capsules three times per day within 30 minutes before breakfast, lunch and dinner
| Study group | Role | What they receive |
|---|---|---|
| dihydrocapsiate 3 mg | Active comparator | • Group 1: 1 Dihydrocapsiate capsule and 2 placebo capsules three times a day within 30 minutes before breakfast, lunch and dinner Receives: Dietary Supplement: dihydrocapsiate capsule |
| dihydrocapsiate 9 mg | Active comparator | • Group 2: 3 Dihydrocapsiate capsules three times per day within 30 minutes before breakfast, lunch and dinner Receives: Dietary Supplement: dihydrocapsiate capsule |
| Placebo capsule | Placebo comparator | • Group 3: 3 placebo capsules three times per day within 30 minutes before breakfast, lunch and dinner Receives: Dietary Supplement: dihydrocapsiate capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adaptive Thermogenesis
To determine the effects of dihydrocapsiate at two doses on the decrease in resting metabolic rate which occurs after a period of very low calorie intake over 4 weeks
Measured: 4 weeks
Secondary outcomes (1)
Diet-Induced thermogenesis
To determine the effects of dihydrocapsiate at two doses on diet-induced thermogenesis (DIT) following a 426 Calorie high protein liquid meal
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 posted11 Jun 2010 (estimated)
- Study startNov 2008
- Primary completionJun 2009
- Study completionAug 2009
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 HealthyStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Heber, MD, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01142687
- Sponsor's protocol ID
- 08-05-113
- Status last verified
- Nov 2016
- First submitted
- 10 Jun 2010
- Last updated
- 28 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee TA, Li Z, Zerlin A, Heber D. Effects of dihydrocapsiate on adaptive and diet-induced thermogenesis with a high protein very low calorie diet: a randomized control trial. Nutr Metab (Lond). 2010 Oct 6;7:78. doi: 10.1186/1743-7075-7-78.
PubMed 20925950
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dihydrocapsiate on Adaptive and Diet-Induced Thermogenesis Following 4 Weeks of Very Low Calorie Diet
- ClinicalTrials.gov ID
- NCT01142687
- Acronym / sponsor ID
- 08-05-113
- Conditions
- Healthy
- Keywords
- Resting energy expenditure (REE), metabolic rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 11 Jun 2010 (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 study is designed to determine the effects of a non-pungent supplement from sweet chilli pepper on resting metabolic rate and diet-induced thermogenesis (DIT) after a period of very low calorie intake over 4 weeks.
Detailed description
Thirty-six subjects will be recruited by public advertisement. Postmenopausal women and men over age 30 with a body mass index (BMI) between 27 to 35 kg/m2,and in good health by history, physical examination, and basic laboratory screening (complete blood count, serum chemistries, liver panel, and lipid panel) will be selected for study. Subjects with type 2 diabetes or glucose intolerance will be excluded as will individuals who regularly drink more than one alcoholic beverage daily. Thirty-six men and women who meet the selection criteria below will be randomly assigned to one of three arms providing CH-19 at two dose levels per day vs. placebo capsules.
This will be a prospectively randomized double blind study in which neither the subjects nor the clinical research personnel will be aware of whether the subjects will be assigned to placebo or dihydrocapsiate at two different doses. A total of 36 subjects will be divided among three groups.
To keep the number of capsules taken by each subject constant, all subjects will take three capsules three times per day containing the appropriate number of active or placebo capsules and will be randomized after screening to one of three groups:
- Group 1: Dihydrocapsiate 1 capsule and 2 placebo capsules three times a day within 30 minutes before breakfast, lunch and dinner.
- Group 2: Dihydrocapsiate 3 capsules three times per day within 30 minutes before breakfast, lunch and dinner
- Group 3: Placebo 3 capsules three times per day within 30 minutes before breakfast, lunch and dinner
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| dihydrocapsiate 3 mg | Active comparator | Dietary Supplement: dihydrocapsiate capsule• Group 1: 1 Dihydrocapsiate capsule and 2 placebo capsules three times a day within 30 minutes before breakfast, lunch and dinner |
| dihydrocapsiate 9 mg | Active comparator | Dietary Supplement: dihydrocapsiate capsule• Group 2: 3 Dihydrocapsiate capsules three times per day within 30 minutes before breakfast, lunch and dinner |
| Placebo capsule | Placebo comparator | Dietary Supplement: dihydrocapsiate capsule• Group 3: 3 placebo capsules three times per day within 30 minutes before breakfast, lunch and dinner |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Postmenopausal female or male over 30 years of age at the time the consent form is signed.
- Subject has a BMI between 27 and 35 kg/m2
- Subject is in good health based on history, physical examination, and basic laboratory studies.
- Consumes less than one alcoholic beverage per day
- Is a non-smoker for at least three months
Key exclusion criteria (15 listed)
- Any subject with known allergy to chili peppers by history.
- Any subject with type 2 diabetes or glucose intolerance
- Consumes more than one alcoholic beverage per day
- Any subject participating in regular vigorous exercises other than ordinary daily walks or who is unwilling to maintain their usual level of exercise during the study.
- Any subject with a diagnosed eating disorder or who is addicted to any medications.
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 |
|---|---|---|
| dihydrocapsiate capsuleAlso: chili pepper* Group 1: 1 dihydrocapsiate capsule and 2 placebo capsules three times a day within 30 minutes before breakfast, lunch and dinner. * Group 2: 3 dihydrocapsiate capsules three times per day within 30 minutes before breakfast, lunch and dinner * Group 3: Placebo 3 capsules three times per day within 30 minutes before breakfast, lunch and dinner | Dietary supplement | Placebo capsule, dihydrocapsiate 3 mg, dihydrocapsiate 9 mg |
Primary outcome
Adaptive Thermogenesis
Time frame: 4 weeks
To determine the effects of dihydrocapsiate at two doses on the decrease in resting metabolic rate which occurs after a period of very low calorie intake over 4 weeks
1 secondary outcome
Diet-Induced thermogenesis
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 28 Nov 2016.
- Results publication: PubMed 20925950Lee TA, Li Z, Zerlin A, Heber D. Effects of dihydrocapsiate on adaptive and diet-induced thermogenesis with a high protein very low calorie diet: a randomized control trial. Nutr Metab (Lond). 2010 Oct 6;7:78. doi: 10.1186/1743-7075-7-78.
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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.
David Heber, MD, PhD principal investigator
University of California, Los Angeles
Questions about this trial
What is this clinical trial studying?
A study testing dihydrocapsiate capsule in people with Healthy, run by University of California, Los Angeles.
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 7 inclusion and 15 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 28 Nov 2016. 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?
Adaptive Thermogenesis (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 NCT01142687, 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 28 Nov 2016.