Effects of Capsimax on Appetite, Energy Intake and Blood Pressure

NCT04874701 | Completed Phase 4

• 1 other identifier: CAPSIMAX
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Body Weight; Weight Loss; Overweight

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• 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

Study Arms (2)

Capsimax

EXPERIMENTAL

Drug: Capsimax; Other: Energy restriction

Placebo

PLACEBO COMPARATOR

Placebo, 2 capsules per day, for 12 weeks

Other: Energy restriction

Interventions

Capsimax DRUG

Capsimax, 2 capsules per day, for 12 weeks Medicinal ingredient: Capsicum annuum Quantity (per capsule): 100.0 mg

Capsimax

Energy restriction OTHER

Personalised diet plan targeting a 500 kcal/day energy restriction

Capsimax; Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laval University: lead
• OmniActive Health Technologies: collaborator

Study Sites (1)

PEPS-Université Laval

Québec, G1V0A6, Canada

Location

MeSH Terms

Conditions

Obesity; Body Weight; Weight Loss; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Angelo Tremblay

  Laval University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 25, 2021
• First Posted: May 6, 2021
• Study Start: January 7, 2018
• Primary Completion: July 2, 2019
• Study Completion: July 2, 2019
• Last Updated: May 6, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)