Effects of Capsimax on Appetite, Energy Intake and Blood Pressure

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Capsimax on Appetite, Energy Intake and Blood Pressure

Conditions
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Obesity, Body Weight, Weight Loss, Overweight

Intervention / Treatment
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* Drug: Capsimax
* Other: Energy restriction


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Capsimax<br> | Drug: Capsimax<br>* Capsimax, 2 capsules per day, for 12 weeks Medicinal ingredient: Capsicum annuum Quantity (per capsule): 100.0 mg<br>Other: Energy restriction<br>* Personalised diet plan targeting a 500 kcal/day energy restriction<br>|
| Placebo Comparator: Placebo<br>Placebo, 2 capsules per day, for 12 weeks | Other: Energy restriction<br>* Personalised diet plan targeting a 500 kcal/day energy restriction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Microbiota analysis at Week 12 | Sequencing of the 16S DNA to evaluate the evolution of the microbiota according to the diet. | 12 weeks | 
| Change from Baseline System analysis of endocannabinoids at Week 12 | The evaluation of the endocannabinoid system done on OpenArray TaqMan according to the expression in RNA of about fifty genes of this system and by their quantification by HPLC coupled to MS / MS mass spectrometry and / or by ion capture. IT-TOF | 12 weeks | 
| Change from Baseline sleeping quality (PSQI) at Week 12 | The Pittsburgh Sleep Quality Index (PSQI) is a validated questionnaire which evaluates sleep quality and disturbance over a 1-month time interval. The PSQI gives a score for seven different components : subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping. medication, and daytime dysfunction | 12 weeks | 
| Change from Baseline Feeding behaviors (TFEQ and Food cravings questionnaire) at Weeks 12 | Feeding behaviors measured by two validated questionnaires : The Three Factor Eating Questionnaire (TFEQ) which measures three main dimensions of human eating behaviors such as cognitive restraint, disinhibition and susceptibility for hunger and the Food cravings questionnaire | 12 weeks | 
| Change from Baseline anxiety (BDI and STAI) at Week 12 | The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. It can be used in clinical settings to diagnose anxiety and to distinguish it from depressive syndromes. The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. | 12 weeks |