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Effects of Capsimax on Appetite, Energy Intake and Blood Pressure

Primary Purpose

Obesity, Body Weight, Weight Loss

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Capsimax
Energy restriction
Sponsored by
Laval University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts 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.

Sites / Locations

  • PEPS-Université Laval

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Capsimax

Placebo

Arm Description

Placebo, 2 capsules per day, for 12 weeks

Outcomes

Primary Outcome Measures

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.
Change from Baseline in energy expenditure at Week 12
Energy expenditure measured at fasting stade, after a 15 minutes rest, by indirect calorimetry
Change from Baseline in Body weight and fat at Week 12
Body weight and fat measured with Dual-energy X-ray absorptiometry (DXA)
Change from Baseline in Blood pressure at Week 12
Blood pressure measured every 30 minutes during a 3h testing

Secondary Outcome Measures

Change from Baseline Microbiota analysis at Week 12
Sequencing of the 16S DNA to evaluate the evolution of the microbiota according to the diet.
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
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
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
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.

Full Information

First Posted
April 25, 2021
Last Updated
April 30, 2021
Sponsor
Laval University
Collaborators
OmniActive Health Technologies
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1. Study Identification

Unique Protocol Identification Number
NCT04874701
Brief Title
Effects of Capsimax on Appetite, Energy Intake and Blood Pressure
Official Title
Effects of Capsimax on Appetite, Energy Intake and Blood Pressure
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
January 7, 2018 (Actual)
Primary Completion Date
July 2, 2019 (Actual)
Study Completion Date
July 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University
Collaborators
OmniActive Health Technologies

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Body Weight, Weight Loss, Overweight

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Capsimax
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, 2 capsules per day, for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Capsimax
Intervention Description
Capsimax, 2 capsules per day, for 12 weeks Medicinal ingredient: Capsicum annuum Quantity (per capsule): 100.0 mg
Intervention Type
Other
Intervention Name(s)
Energy restriction
Intervention Description
Personalised diet plan targeting a 500 kcal/day energy restriction
Primary Outcome Measure Information:
Title
Change from Baseline in appetite sensations, energy intake and food preferences at Week 12
Description
Visual analog scales used after a standardized breakfast and a buffet-type meal to measure hunger, fullness, satiety and desire to eat.
Time Frame
12 weeks
Title
Change from Baseline in energy expenditure at Week 12
Description
Energy expenditure measured at fasting stade, after a 15 minutes rest, by indirect calorimetry
Time Frame
12 weeks
Title
Change from Baseline in Body weight and fat at Week 12
Description
Body weight and fat measured with Dual-energy X-ray absorptiometry (DXA)
Time Frame
12 weeks
Title
Change from Baseline in Blood pressure at Week 12
Description
Blood pressure measured every 30 minutes during a 3h testing
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change from Baseline Microbiota analysis at Week 12
Description
Sequencing of the 16S DNA to evaluate the evolution of the microbiota according to the diet.
Time Frame
12 weeks
Title
Change from Baseline System analysis of endocannabinoids at Week 12
Description
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
Time Frame
12 weeks
Title
Change from Baseline sleeping quality (PSQI) at Week 12
Description
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
Time Frame
12 weeks
Title
Change from Baseline Feeding behaviors (TFEQ and Food cravings questionnaire) at Weeks 12
Description
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
Time Frame
12 weeks
Title
Change from Baseline anxiety (BDI and STAI) at Week 12
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angelo Tremblay
Organizational Affiliation
Laval University
Official's Role
Principal Investigator
Facility Information:
Facility Name
PEPS-Université Laval
City
Québec
ZIP/Postal Code
G1V0A6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Capsimax on Appetite, Energy Intake and Blood Pressure

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