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

NCT01142687 | Completed

• 1 other identifier: 08-05-113
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Healthy

Keywords

Resting energy expenditure (REE); metabolic rate

Outcome Measures

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

  4 weeks

Secondary Outcomes (1)

• Diet-Induced thermogenesis

  4 weeks

Study Arms (3)

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

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

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

Dietary Supplement: dihydrocapsiate capsule

Interventions

dihydrocapsiate capsule DIETARY_SUPPLEMENT

* 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

Placebo capsule; dihydrocapsiate 3 mg; dihydrocapsiate 9 mg

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Related Publications (1)

• 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.

  PMID: 20925950 RESULT

MeSH Terms

Interventions

capsiate

Study Officials

• David Heber, MD, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2010
• First Posted: June 11, 2010
• Study Start: November 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: August 1, 2009
• Last Updated: November 28, 2016

Record last verified: 2016-11