To Evaluate the Efficacy of Capsimax on Metabolic Rate

Not Applicable

Completed

• Conditions: Metabolism
• Interventions: Other: Capsimax; Other: Micro Crystalline Cellulose

• Registration Number: NCT04025346
• Lead Sponsor: Vedic Lifesciences Pvt. Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-08
• Study First Submitted QC: 2019-07-17
• Study First Posted: 2019-07-18
• Study Start: 2019-10-17
• Status Verified: 2019-12
• Primary Completion: 2020-03-23
• Study Completion: 2020-03-30
• Last Update Submitted: 2020-08-26
• Last Update Posted: 2020-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Capsimax	Capsimax	-
Capsimax	Micro Crystalline Cellulose	-
Placebo	Capsimax	-
Placebo	Micro Crystalline Cellulose	-

Primary Outcome Measures

Name	Time	Method
Effect of Investigational Product on Resting Energy Expenditure	From baseline to 4 hours.	Assessed by Indirect Calorimetry

Trial Locations

Locations (1)

Vedic Lifesciences Pvt. Ltd.; 🇮🇳 Thāne, Maharashtra, India