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
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.
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:
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.
Inclusion Criteria:a.
Exclusion Criteria:
• 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
• Group 2: 3 Dihydrocapsiate capsules three times per day within 30 minutes before breakfast, lunch and dinner
Dietary Supplement: dihydrocapsiate capsule
• Group 3: 3 placebo capsules three times per day within 30 minutes before breakfast, lunch and dinner
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. * 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
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
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
No study locations are listed for this record.
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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