Sponsor study identifier
interventional
63
1 country
1
Study Start
January 7, 2018
Actual (reported)Primary Completion
July 2, 2019
Actual (reported)Study Completion
July 2, 2019
Actual (reported)Obesity is an ongoing major public health problem in most countries of the world for which the agrifood industry still remains criticized because of the abundant offer of high sugar-lipid-energy dense foods, particularly in the fast-food sector. The resulting societal pressure on the food industry probably explains in part the efforts that have been deployed to seek natural active ingredients and to develop functional foods favorably influencing energy balance. Capsaicin is a food non-nutrient constituent that was shown to decrease appetite sensations and subsequent energy intake. The measurement of heart rate variability revealed an association between the increase in sympathetic nervous system (SNS) activity and the satiating effects induced by capsaicin. This is concordant with the observation that pre-prandial intake of capsaicin, be it in capsules or diluted in tomato juice, increased satiety and reduced energy intake. The objective of this study is to evaluate the long effects of Capsimax on appetite sensations and energy expenditure under conditions of moderate energy restriction and to evaluate the long-term effects of Capsimax on energy intake and expenditure under conditions of moderate energy restriction.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 7, 2018
Actual (reported)July 2, 2019
Actual (reported)July 2, 2019
Actual (reported)April 25, 2021
Actual (reported)May 6, 2021
Actual (reported)Change from Baseline in appetite sensations, energy intake and food preferences at Week 12
Visual analog scales used after a standardized breakfast and a buffet-type meal to measure hunger, fullness, satiety and desire to eat.
12 weeks
Change from Baseline in energy expenditure at Week 12
Energy expenditure measured at fasting stade, after a 15 minutes rest, by indirect calorimetry
12 weeks
Change from Baseline in Body weight and fat at Week 12
Body weight and fat measured with Dual-energy X-ray absorptiometry (DXA)
12 weeks
Change from Baseline in Blood pressure at Week 12
Blood pressure measured every 30 minutes during a 3h testing
12 weeks
Change from Baseline Microbiota analysis at Week 12
12 weeks
Change from Baseline System analysis of endocannabinoids at Week 12
12 weeks
Change from Baseline sleeping quality (PSQI) at Week 12
12 weeks
Change from Baseline Feeding behaviors (TFEQ and Food cravings questionnaire) at Weeks 12
12 weeks
Change from Baseline anxiety (BDI and STAI) at Week 12
12 weeks
Placebo, 2 capsules per day, for 12 weeks
Capsimax, 2 capsules per day, for 12 weeks Medicinal ingredient: Capsicum annuum Quantity (per capsule): 100.0 mg
Personalised diet plan targeting a 500 kcal/day energy restriction
PEPS-Université Laval
Québec, G1V0A6, Canada
Angelo Tremblay
Laval University
63 participants (actual enrollment reported by the registry).
First Submitted
April 25, 2021
First Posted
May 6, 2021
Study Start
January 7, 2018
Actual (reported)Saxenda in Obesity Services (STRIVE Study)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
July 2, 2019
Actual (reported)Study Completion
July 2, 2019
Actual (reported)Last Updated
May 6, 2021
Record last verified: 2021-04
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Source: ClinicalTrials.gov.
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