NCT04025346

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 18, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

October 17, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2020

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
Last Updated

August 27, 2020

Status Verified

December 1, 2019

Enrollment Period

5 months

First QC Date

July 8, 2019

Last Update Submit

August 26, 2020

Conditions

Metabolism

Outcome Measures

Primary Outcomes (1)

  • Effect of Investigational Product on Resting Energy Expenditure

    Assessed by Indirect Calorimetry

    From baseline to 4 hours.

Study Arms (2)

Capsimax

ACTIVE COMPARATOR
Other: CapsimaxOther: Micro Crystalline Cellulose

Placebo

PLACEBO COMPARATOR
Other: CapsimaxOther: Micro Crystalline Cellulose

Interventions

CapsimaxOTHER

1 capsule to be taken before breakfast.

CapsimaxPlacebo
Micro Crystalline CelluloseOTHER

1 capsule to be taken before breakfast.

CapsimaxPlacebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Post-menopausal females
  • History of hypo/ hyperthyroidism.
  • History of significant neurological or psychiatric condition such as seizures, depression, or insomnia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vedic Lifesciences Pvt. Ltd.

Thane, Maharashtra, 400602, India

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Double blind, randomized, placebo controlled
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2019

First Posted

July 18, 2019

Study Start

October 17, 2019

Primary Completion

March 23, 2020

Study Completion

March 30, 2020

Last Updated

August 27, 2020

Record last verified: 2019-12

Locations

IN(1)