Effects of Capsimax on Appetite, Energy Intake and Blood Pressure

NCT ID: NCT04874701

Last Updated: 2021-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-07
• Study Completion Date: 2019-07-02

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Capsimax

Group Type: EXPERIMENTAL

Capsimax

Intervention Type: DRUG

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

Energy restriction

Intervention Type: OTHER

Personalised diet plan targeting a 500 kcal/day energy restriction

Placebo

Placebo, 2 capsules per day, for 12 weeks

Group Type: PLACEBO_COMPARATOR

Energy restriction

Intervention Type: OTHER

Personalised diet plan targeting a 500 kcal/day energy restriction

Interventions

Capsimax

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

Intervention Type: DRUG

Energy restriction

Personalised diet plan targeting a 500 kcal/day energy restriction

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

OmniActive Health Technologies

INDUSTRY

Sponsor Role: collaborator

Laval University

OTHER

Sponsor Role: lead

Responsible Party

Angelo Tremblay

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Angelo Tremblay

Role: PRINCIPAL_INVESTIGATOR

Laval University

Locations

PEPS-Université Laval

Québec, , Canada

Countries

Canada

Other Identifiers

CAPSIMAX

Identifier Type: -

Identifier Source: org_study_id