To Evaluate the Efficacy of Capsimax on Metabolic Rate

NCT ID: NCT04025346

Last Updated: 2020-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-17

Study Completion Date

2020-03-30

Brief Summary

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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

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Conditions

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Metabolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Double blind, randomized, placebo controlled
Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Capsimax

Group Type ACTIVE_COMPARATOR

Capsimax

Intervention Type OTHER

1 capsule to be taken before breakfast.

Micro Crystalline Cellulose

Intervention Type OTHER

1 capsule to be taken before breakfast.

Placebo

Group Type PLACEBO_COMPARATOR

Capsimax

Intervention Type OTHER

1 capsule to be taken before breakfast.

Micro Crystalline Cellulose

Intervention Type OTHER

1 capsule to be taken before breakfast.

Interventions

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Capsimax

1 capsule to be taken before breakfast.

Intervention Type OTHER

Micro Crystalline Cellulose

1 capsule to be taken before breakfast.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vedic Lifesciences Pvt. Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Vedic Lifesciences Pvt. Ltd.

Thāne, Maharashtra, India

Site Status

Countries

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India

Other Identifiers

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OM/190402/CAPSIMAX

Identifier Type: -

Identifier Source: org_study_id

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