Effects of Capsimax on Appetite, Energy Intake and Blood Pressure

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight; Body Weight; Weight Loss
• Intervention / Treatment: Drug: Capsimax; Other: Energy restriction

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Québec, Canada, G1V0A6
    • PEPS-Université Laval

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Capsimax	Drug: Capsimax; Capsimax, 2 capsules per day, for 12 weeks Medicinal ingredient: Capsicum annuum Quantity (per capsule): 100.0 mg; Other: Energy restriction; Personalised diet plan targeting a 500 kcal/day energy restriction
PLACEBO_COMPARATOR: Placebo; Placebo, 2 capsules per day, for 12 weeks	Other: Energy restriction; Personalised diet plan targeting a 500 kcal/day energy restriction

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Laval University
• Collaborators: OmniActive Health Technologies
• Investigators: Principal Investigator: Angelo Tremblay, Laval University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 7, 2018
• Primary Completion (ACTUAL): July 2, 2019
• Study Completion (ACTUAL): July 2, 2019

Study Registration Dates

• First Submitted: April 25, 2021
• First Submitted That Met QC Criteria: April 30, 2021
• First Posted (ACTUAL): May 6, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 6, 2021
• Last Update Submitted That Met QC Criteria: April 30, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Overweight; Body Weight
• Other Study ID Numbers: CAPSIMAX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No