CompletedNot Applicable

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

58 participantsStarted 2008-11

Plain-language 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.

Who can participate

Age range30 Years – 65 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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

What they're measuring

Adaptive Thermogenesis

Timeframe: 4 weeks

Trial details

NCT IDNCT01142687

SponsorUniversity of California, Los Angeles

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-06

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