Clinical trial NCT04874701: Effects of Capsimax on Appetite, Energy Intake and Blood Pressure
Official title: Effects of Capsimax on Appetite, Energy Intake and Blood Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obesity
Body Weight
Weight Loss
Overweight
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: OmniActive Health Technologies
First posted: 2021-05-06
Enrollment: 63
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Premenopausal women
* Between 18 and 50 years
* Healthy
* Non-smoker
* BMI between 25 and 35 kg/m2
* Weight stability

Exclusion Criteria:

* Pregnant or menopausal woman
* History of losing and gaining weight (yo-yo)
* Taking medication for diabetes, hypertension, depression, or hypothyroid
* Taking a supplement for weight loss
* Vegetarian, vegan, intolerant to gluten or pepper (investigational product), and severe allergy to peanuts or nuts
* Suffers from Irritable Bowel Syndrome or gastro-oesophageal reflux
* Suffers from stomach ulcers or inflammation
* Other serious conditions such as cardiovascular, renal, liver, and lung diseases
* History of drug abuse and current alcohol abuse
* Use of any medication (including over-the-counter medications and herbal remedies) such as grapefruit juice, piperine, NSAIDs, etc.

Primary outcomes:
measure: Change from Baseline in appetite sensations, energy intake and food preferences at Week 12
timeFrame: 12 weeks
measure: Change from Baseline in energy expenditure at Week 12
timeFrame: 12 weeks
measure: Change from Baseline in Body weight and fat at Week 12
timeFrame: 12 weeks
measure: Change from Baseline in Blood pressure at Week 12
timeFrame: 12 weeks
Secondary outcomes:
measure: Change from Baseline Microbiota analysis at Week 12
timeFrame: 12 weeks
measure: Change from Baseline System analysis of endocannabinoids at Week 12
timeFrame: 12 weeks
measure: Change from Baseline sleeping quality (PSQI) at Week 12
timeFrame: 12 weeks
measure: Change from Baseline Feeding behaviors (TFEQ and Food cravings questionnaire) at Weeks 12
timeFrame: 12 weeks
measure: Change from Baseline anxiety (BDI and STAI) at Week 12
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Québec
country: Canada
facility: PEPS-Université Laval
Study officials:
affiliation: Laval University
name: Angelo Tremblay
role: PRINCIPAL_INVESTIGATOR
References: