ObesityPhase 4NCT04874701
Effects of Capsimax on Appetite, Energy Intake and Blood Pressure
A Phase 4 study testing Capsimax and Energy restriction in people with Obesity and Body Weight, run by Laval University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Body Weight, Weight Loss
- What is being tested?
- Capsimax and Energy restriction
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteCanada
- Study dates
- 7 Jan 2018to 2 Jul 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Premenopausal women
- Between 18 and 50 years
- Healthy
- Non-smoker
- BMI between 25 and 35 kg/m2
- Weight stability
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Capsimax, Energy restriction
- Medical subject headings
- Obesity, Body Weight, Weight Loss, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapsimaxDrug
Capsimax, 2 capsules per day, for 12 weeks Medicinal ingredient: Capsicum annuum Quantity (per capsule): 100.0 mg
Energy restrictionOther
Personalised diet plan targeting a 500 kcal/day energy restriction
| Study group | Role | What they receive |
|---|---|---|
| Capsimax | Experimental | Not described Receives: Drug: Capsimax; Other: Energy restriction |
| Placebo | Placebo comparator | Placebo, 2 capsules per day, for 12 weeks Receives: Other: Energy restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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)
Measured: 12 weeks
Change from Baseline in Blood pressure at Week 12
Blood pressure measured every 30 minutes during a 3h testing
Measured: 12 weeks
Secondary outcomes (5)
Change from Baseline Microbiota analysis at Week 12
Sequencing of the 16S DNA to evaluate the evolution of the microbiota according to the diet.
Measured: 12 weeks
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
Measured: 12 weeks
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
Measured: 12 weeks
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
Measured: 12 weeks
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start7 Jan 2018
- Primary completion2 Jul 2019
- Study completion2 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- OmniActive Health Technologies
- Responsible party
- Principal investigator, Angelo Tremblay, Laval University
- Investigators
- Angelo Tremblay, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04874701
- Sponsor's protocol ID
- CAPSIMAX
- Status last verified
- Apr 2021
- First submitted
- 25 Apr 2021
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Capsimax on Appetite, Energy Intake and Blood Pressure
- ClinicalTrials.gov ID
- NCT04874701
- Acronym / sponsor ID
- CAPSIMAX
- Conditions
- Obesity, Body Weight, Weight Loss, Overweight
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- OmniActive Health Technologies
- Study start
- 7 Jan 2018 (actual)
- Primary completion
- 2 Jul 2019 (actual)
- Study completion
- 2 Jul 2019 (actual)
- First posted
- 6 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capsimax | Experimental | Drug: Capsimax, Other: Energy restriction |
| Placebo | Placebo comparator | Other: Energy restrictionPlacebo, 2 capsules per day, for 12 weeks |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Premenopausal women
- Between 18 and 50 years
- Healthy
- Non-smoker
- BMI between 25 and 35 kg/m2
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CapsimaxCapsimax, 2 capsules per day, for 12 weeks Medicinal ingredient: Capsicum annuum Quantity (per capsule): 100.0 mg | Drug | Capsimax |
| Energy restrictionPersonalised diet plan targeting a 500 kcal/day energy restriction | Other | Capsimax, Placebo |
Primary outcome
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.
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
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)
Change from Baseline in Blood pressure at Week 12
Time frame: 12 weeks
Blood pressure measured every 30 minutes during a 3h testing
5 secondary outcomes
Change from Baseline Microbiota analysis at Week 12
Time frame: 12 weeks
Change from Baseline System analysis of endocannabinoids at Week 12
Time frame: 12 weeks
Change from Baseline sleeping quality (PSQI) at Week 12
Time frame: 12 weeks
Change from Baseline Feeding behaviors (TFEQ and Food cravings questionnaire) at Weeks 12
Time frame: 12 weeks
Change from Baseline anxiety (BDI and STAI) at Week 12
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
- Individual participant dataSharing planned: No
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angelo Tremblay principal investigator
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Capsimax and Energy restriction in people with Obesity and Body Weight, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in appetite sensations, energy intake and food preferences at Week 12 (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2021.