To Evaluate the Efficacy of Capsimax on Metabolic Rate

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.

Study Overview

• Status: Completed
• Conditions: Metabolism
• Intervention / Treatment: Other: Capsimax; Other: Micro Crystalline Cellulose

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Maharashtra
    • Thāne, Maharashtra, India, 400602
      • Vedic Lifesciences Pvt. Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Capsimax; 1 capsule to be taken before breakfast.; Other: Micro Crystalline Cellulose; 1 capsule to be taken before breakfast.
Active Comparator: Capsimax	Other: Capsimax; 1 capsule to be taken before breakfast.; Other: Micro Crystalline Cellulose; 1 capsule to be taken before breakfast.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of Investigational Product on Resting Energy Expenditure	Assessed by Indirect Calorimetry	From baseline to 4 hours.

Collaborators and Investigators

• Sponsor: Vedic Lifesciences Pvt. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2019
• Primary Completion (Actual): March 23, 2020
• Study Completion (Actual): March 30, 2020

Study Registration Dates

• First Submitted: July 8, 2019
• First Submitted That Met QC Criteria: July 17, 2019
• First Posted (Actual): July 18, 2019

Study Record Updates

• Last Update Posted (Actual): August 27, 2020
• Last Update Submitted That Met QC Criteria: August 26, 2020
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: OM/190402/CAPSIMAX

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No