Effects of Capsimax on Appetite, Energy Intake and Blood Pressure

Laval University

Status and phase: Completed; Phase 4

Conditions: Weight Loss; Overweight; Obesity; Body Weight

Treatments: Other: Energy restriction; Drug: Capsimax

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04874701

CAPSIMAX

Details and patient eligibility

About

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.

Enrollment: 63 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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63 participants in 2 patient groups, including a placebo group

Capsimax

Experimental group

Treatment:

Drug: Capsimax

Other: Energy restriction

Placebo

Placebo Comparator group

Description:

Placebo, 2 capsules per day, for 12 weeks

Treatment:

Other: Energy restriction