To Evaluate the Efficacy of Capsimax on Metabolic Rate | NCT04025346

Studies
To Evaluate the Efficacy of Capsimax on Metabolic Rate

NCT04025346

Sponsor

Vedic Lifesciences Pvt. Ltd.

Status

Completed

Last Update Posted

Aug 27, 2020Actual

Enrollment

44Actual

Phase

Not Applicable

Conditions

Metabolism

Interventions

Capsimax
Micro Crystalline Cellulose

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 17, 2019Actual

Primary Completion Date

Mar 23, 2020Actual

Completion Date

Mar 30, 2020Actual

First Submitted Date

Jul 8, 2019

First Submission Date that Met QC Criteria

Jul 17, 2019

First Posted Date

Jul 18, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 26, 2020

Last Update Posted Date

Aug 27, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

44Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Capsimax	Active Comparator		Other: Capsimax Other: Micro Crystalline Cellulose
Placebo	Placebo Comparator		Other: Capsimax Other: Micro Crystalline Cellulose

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Capsimax	Other	1 capsule to be taken before breakfast.	Capsimax Placebo

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vedic Lifesciences Pvt. Ltd.		Thane	Maharashtra	400602	India