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NCT04025346 Clinical Trial

To Evaluate the Efficacy of Capsimax on Metabolic Rate

Metabolism Clinical Trial

Official title:
A Randomized, Double-blind, Placebo-controlled, Cross-over Study to Evaluate the Efficacy of Capsimax on Metabolic Rate

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04025346
Other study ID # OM/190402/CAPSIMAX
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 17, 2019
Est. completion date March 30, 2020

Study information
Verified date December 2019
Source Vedic Lifesciences Pvt. Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

Recruitment information / eligibility
Status Completed
Enrollment 44
Est. completion date March 30, 2020
Est. primary completion date March 23, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- Post-menopausal females

- History of hypo/ hyperthyroidism.

- History of significant neurological or psychiatric condition such as seizures, depression, or insomnia.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Capsimax
1 capsule to be taken before breakfast.
• Micro Crystalline Cellulose
1 capsule to be taken before breakfast.

Locations
Country Name City State
India Vedic Lifesciences Pvt. Ltd. Thane Maharashtra

Sponsors (1)
Lead Sponsor Collaborator
Vedic Lifesciences Pvt. Ltd.

Country where clinical trial is conducted

India, 

Outcome
Type Measure Description Time frame Safety issue
Primary Effect of Investigational Product on Resting Energy Expenditure Assessed by Indirect Calorimetry From baseline to 4 hours.
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