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出境医 / 临床实验 / To Evaluate the Efficacy of Capsimax on Metabolic Rate

To Evaluate the Efficacy of Capsimax on Metabolic Rate

Study Description
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.

Condition or disease Intervention/treatment Phase
Metabolism Other: Capsimax Other: Micro Crystalline Cellulose Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Double blind, randomized, placebo controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: A Randomized, Double-blind, Placebo-controlled, Cross-over Study to Evaluate the Efficacy of Capsimax on Metabolic Rate
Actual Study Start Date : October 17, 2019
Actual Primary Completion Date : March 23, 2020
Actual Study Completion Date : March 30, 2020
Arms and Interventions
Arm Intervention/treatment
Active Comparator: Capsimax Other: Capsimax
1 capsule to be taken before breakfast.

Other: Micro Crystalline Cellulose
1 capsule to be taken before breakfast.
Placebo Comparator: Placebo Other: Capsimax
1 capsule to be taken before breakfast.

Other: Micro Crystalline Cellulose
1 capsule to be taken before breakfast.
Outcome Measures
Primary Outcome Measures :
  1. Effect of Investigational Product on Resting Energy Expenditure [ Time Frame: From baseline to 4 hours. ]
    Assessed by Indirect Calorimetry


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations

Locations
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India
Vedic Lifesciences Pvt. Ltd.
Thāne, Maharashtra, India, 400602
Sponsors and Collaborators
Vedic Lifesciences Pvt. Ltd.
Tracking Information
First Submitted Date  ICMJE July 8, 2019
First Posted Date  ICMJE July 18, 2019
Last Update Posted Date August 27, 2020
Actual Study Start Date  ICMJE October 17, 2019
Actual Primary Completion Date March 23, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2019) 		Effect of Investigational Product on Resting Energy Expenditure [ Time Frame: From baseline to 4 hours. ]
Assessed by Indirect Calorimetry
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE To Evaluate the Efficacy of Capsimax on Metabolic Rate
Official Title  ICMJE A Randomized, Double-blind, Placebo-controlled, Cross-over Study to Evaluate the Efficacy of Capsimax on Metabolic Rate
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Double blind, randomized, placebo controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Metabolism
Intervention  ICMJE
  • Other: Capsimax
    1 capsule to be taken before breakfast.
  • Other: Micro Crystalline Cellulose
    1 capsule to be taken before breakfast.
Study Arms  ICMJE
  • Active Comparator: Capsimax
    Interventions:
    • Other: Capsimax
    • Other: Micro Crystalline Cellulose
  • Placebo Comparator: Placebo
    Interventions:
    • Other: Capsimax
    • Other: Micro Crystalline Cellulose
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 26, 2020) 		44
Original Estimated Enrollment  ICMJE
 (submitted: July 17, 2019) 		35
Actual Study Completion Date  ICMJE March 30, 2020
Actual Primary Completion Date March 23, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04025346
Other Study ID Numbers  ICMJE OM/190402/CAPSIMAX
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vedic Lifesciences Pvt. Ltd.
Study Sponsor  ICMJE Vedic Lifesciences Pvt. Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Vedic Lifesciences Pvt. Ltd.
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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