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Completed

NCT Number: NCT04874701

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.

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Key information

Conditions

Obesity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

PEPS-Université Laval

Québec, G1V0A6, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Capsimax

Drug

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

Energy restriction

Other

Personalised diet plan targeting a 500 kcal/day energy restriction

Primary outcomes

  1. Change from Baseline in appetite sensations, energy intake and food preferences at Week 12

    Time frame: 12 weeks

    Visual analog scales used after a standardized breakfast and a buffet-type meal to measure hunger, fullness, satiety and desire to eat.

  2. Change from Baseline in energy expenditure at Week 12

    Time frame: 12 weeks

    Energy expenditure measured at fasting stade, after a 15 minutes rest, by indirect calorimetry

  3. Change from Baseline in Body weight and fat at Week 12

    Time frame: 12 weeks

    Body weight and fat measured with Dual-energy X-ray absorptiometry (DXA)

  4. Change from Baseline in Blood pressure at Week 12

    Time frame: 12 weeks

    Blood pressure measured every 30 minutes during a 3h testing

Secondary outcomes

  1. Change from Baseline Microbiota analysis at Week 12

    Time frame: 12 weeks

    Sequencing of the 16S DNA to evaluate the evolution of the microbiota according to the diet.

  2. Change from Baseline System analysis of endocannabinoids at Week 12

    Time frame: 12 weeks

    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

  3. Change from Baseline sleeping quality (PSQI) at Week 12

    Time frame: 12 weeks

    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

  4. Change from Baseline Feeding behaviors (TFEQ and Food cravings questionnaire) at Weeks 12

    Time frame: 12 weeks

    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

  5. Change from Baseline anxiety (BDI and STAI) at Week 12

    Time frame: 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

Laval University

Other

Collaborators

  • OmniActive Health Technologies

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 6, 2021
Registry last updated
May 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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