MetabolismNCT04025346
To Evaluate the Efficacy of Capsimax on Metabolic Rate
A study testing Capsimax and Micro Crystalline Cellulose in people with Metabolism, run by Vedic Lifesciences Pvt. Ltd. at 1 site in India.
Trial summary
Capsimax™ is a proprietary Capsicum Extract that employs Beadlet Technology. In the previous study it has been used to investigate its effect in reducing body fat/weight and increase metabolic rate. In this study, Capsimax™ will be used to assess effect on Resting Energy Expenditure (REE) using Indirect Calorimetry. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolism
- What is being tested?
- Capsimax and Micro Crystalline Cellulose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteIndia
- Study dates
- 17 Oct 2019to 30 Mar 2020
- Phase
- Interventional
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, adult, male/female participants with age ≥ 18 ≤ 55 years.
- A Body Mass Index (BMI) between 18.5 to 29.9 kg/m2.
- Fasting blood sugar ≤ 100 mg/dl
- Hemoglobin: Males ≥ 11 g/dl and Females ≥ 10 g/dl
- BP < 140/90 mmHg
Who cannot join
- Post-menopausal females
- History of hypo/ hyperthyroidism.
- History of significant neurological or psychiatric condition such as seizures, depression, or insomnia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Cross-over Study to Evaluate the Efficacy of Capsimax on Metabolic Rate
Capsimax™ is a proprietary Capsicum Extract that employs Beadlet Technology. In the previous study it has been used to investigate its effect in reducing body fat/weight and increase metabolic rate. In this study, Capsimax™ will be used to assess effect on Resting Energy Expenditure (REE) using Indirect Calorimetry.
- Conditions
- Metabolism
- Being tested
- Capsimax, Micro Crystalline Cellulose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapsimaxOther
1 capsule to be taken before breakfast.
Micro Crystalline CelluloseOther
1 capsule to be taken before breakfast.
| Study group | Role | What they receive |
|---|---|---|
| Capsimax | Active comparator | Not described Receives: Other: Capsimax; Other: Micro Crystalline Cellulose |
| Placebo | Placebo comparator | Not described Receives: Other: Capsimax; Other: Micro Crystalline Cellulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Investigational Product on Resting Energy Expenditure
Assessed by Indirect Calorimetry
Measured: From baseline to 4 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start17 Oct 2019
- Primary completion23 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MetabolismStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double blind, randomized, placebo controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04025346
- Sponsor's protocol ID
- OM/190402/CAPSIMAX
- Status last verified
- Dec 2019
- First submitted
- 8 Jul 2019
- Last updated
- 27 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Cross-over Study to Evaluate the Efficacy of Capsimax on Metabolic Rate
- ClinicalTrials.gov ID
- NCT04025346
- Acronym / sponsor ID
- OM/190402/CAPSIMAX
- Conditions
- Metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Oct 2019 (actual)
- Primary completion
- 23 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 18 Jul 2019 (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.
Capsimax™ is a proprietary Capsicum Extract that employs Beadlet Technology. In the previous study it has been used to investigate its effect in reducing body fat/weight and increase metabolic rate. In this study, Capsimax™ will be used to assess effect on Resting Energy Expenditure (REE) using Indirect Calorimetry.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blind, randomized, placebo controlled
| Arm | Type | Receives |
|---|---|---|
| Capsimax | Active comparator | Other: Capsimax, Other: Micro Crystalline Cellulose |
| Placebo | Placebo comparator | Other: Capsimax, Other: Micro Crystalline Cellulose |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy, adult, male/female participants with age ≥ 18 ≤ 55 years.
- A Body Mass Index (BMI) between 18.5 to 29.9 kg/m2.
- Fasting blood sugar ≤ 100 mg/dl
- Hemoglobin: Males ≥ 11 g/dl and Females ≥ 10 g/dl
- BP < 140/90 mmHg
Key exclusion criteria (3 listed)
- Post-menopausal females
- History of hypo/ hyperthyroidism.
- History of significant neurological or psychiatric condition such as seizures, depression, or insomnia.
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 |
|---|---|---|
| Capsimax1 capsule to be taken before breakfast. | Other | Capsimax, Placebo |
| Micro Crystalline Cellulose1 capsule to be taken before breakfast. | Other | Capsimax, Placebo |
Primary outcome
Effect of Investigational Product on Resting Energy Expenditure
Time frame: From baseline to 4 hours.
Assessed by Indirect Calorimetry
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 27 Aug 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Capsimax and Micro Crystalline Cellulose in people with Metabolism, run by Vedic Lifesciences Pvt. Ltd. at 1 site in India.
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 5 inclusion and 3 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 27 Aug 2020. 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 India. 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.
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?
Effect of Investigational Product on Resting Energy Expenditure (time frame: From baseline to 4 hours.). 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 27 Aug 2020.