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CompletedNCT01142687Updated Nov 28, 2016

Effects of Dihydrocapsiate on Adaptive and Diet-Induced Thermogenesis With a High Protein Very Low Calorie Diet

An interventional study of dihydrocapsiate capsule in Healthy, sponsored by University of California, Los Angeles. Completed. Open to participants aged 30 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-28.

Sponsored by University of California, Los Angeles · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
58
Allocation
Randomized
Ages
30 Years to 65 Years
Sex
All
01

Study 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 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
02

Conditions studied

  • Healthy

Keywords

  • Resting energy expenditure (REE)
  • metabolic rate
03

In context

Lead sponsor

University of California, Los Angeles is the lead sponsor of 1,167 studies on the registry; 192 are open to participants now.

Of its 94 completed or terminated interventional studies of FDA-regulated products, 69 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria:a.

  1. Postmenopausal female or male over 30 years of age at the time the consent form is signed.
  2. Subject has a BMI between 27 and 35 kg/m2
  3. Subject is in good health based on history, physical examination, and basic laboratory studies.
  4. Consumes less than one alcoholic beverage per day
  5. Is a non-smoker for at least three months
  6. Willing to follow a Very Low Calorie Diet of 800 calories per day using meal replacements
  7. 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.

Exclusion Criteria:

  1. Any subject with known allergy to chili peppers by history.
  2. Any subject with type 2 diabetes or glucose intolerance
  3. Consumes more than one alcoholic beverage per day
  4. 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.
  5. Any subject with a diagnosed eating disorder or who is addicted to any medications.
  6. Any subject currently taking antidepressants or weight loss medication.
  7. 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.
  8. Major surgery within 12 weeks prior to subject randomization and/or screening, especially cardiac surgery
  9. 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.
  10. Known HIV positive.
  11. Clinical evidence of current malignancy with the exception of basal cell or squamous cell carcinoma of the skin and cervical intraepithelial neoplasia.
  12. Currently receiving systemic chemotherapy and/or radiotherapy.
  13. Active bleeding.
  14. 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.
  15. 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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
58 participants (actual)

Study arms

  • Active comparator
    dihydrocapsiate 3 mg

    • Group 1: 1 Dihydrocapsiate capsule and 2 placebo capsules three times a day within 30 minutes before breakfast, lunch and dinner

    Dietary Supplement: dihydrocapsiate capsule

  • Active comparator
    dihydrocapsiate 9 mg

    • Group 2: 3 Dihydrocapsiate capsules three times per day within 30 minutes before breakfast, lunch and dinner

    Dietary Supplement: dihydrocapsiate capsule

  • Placebo comparator
    Placebo capsule

    • Group 3: 3 placebo capsules three times per day within 30 minutes before breakfast, lunch and dinner

    Dietary Supplement: dihydrocapsiate capsule

Interventions

  • Dietary supplementdihydrocapsiate capsule

    * 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

    Also known as: chili pepper

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 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

    Time frame: 4 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 28, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01142687
Responsible party
Sponsor
First posted
Jun 11, 2010
Start date
Nov 2008
Primary completion
Jun 2009
Completion
Aug 2009
Last update
Nov 28, 2016

Study contacts

David Heber, MD, PhD
principal investigator · University of California, Los Angeles

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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