Status:

UNKNOWN

Efficacy Of Trimrox On Body Recomposition And Weight Management (TRCAP21)

Lead Sponsor:

Victory Nutrition International, Inc.

Conditions:

Body Weight Changes

Eligibility:

All Genders

30-70 years

Phase:

NA

Brief Summary

Protocol Number: VNI/121/TrimRox: A unique stimulant- and sugar-free TRCAP21 Prodosomed® nutraceutical formulation, TrimROXTM, has been developed in a cGMP and NSF-certified manufacturing facility th...

Detailed Description

CDC reports that in the USA, the prevalence of obesity was 40% in adults between 20 and 39 years, 44.8% in adults between 40 and 59 years, and 42.8% in people 60 years and older. Furthermore, the CDC ...

Eligibility Criteria

Inclusion

  • Inclusion Criteria
  • Agrees to sign written and audio-visual informed consent.
  • Fully understand the risks and benefits of the study
  • Male and Female Subjects (age: 30-70 Y)
  • Subjects are deemed to be acceptable for this study by their physician
  • Exclusion Criteria
  • Subjects who are unwilling or uncooperative subjects
  • Subjects were excluded who had impaired hepatic functions i,e., SGOT/SGPT \>2.5 X
  • Subjects suffering from type 1 diabetes
  • Subjects suffering from type 2 diabetes or anyone else that has a blood glucose levels \>180 mg/dl or HbA1c \> 8.
  • Subjects who were suffering from coronary artery disease or high blood pressure \>180/100
  • Subjects who were exhibiting abnormal hepatic or kidney functions (ALT or AST \> 2 X greater than normal value); elevated creatinine, males \> 125 μmol/L or 1.4mg/dl
  • Subjects who have cancer and are suffering from a malignancy.
  • Hypersensitivity to the investigational supplement
  • Subjects who had used any known weight management supplement for the last 2 months.
  • History of blood coagulation and bleeding (coagulopathies)
  • Incidence of high alcohol intake (more than 2 standard drinks/day).
  • Psychiatric disorder/disability provide signed informed consent.
  • Existing medical condition of the participant, which may be detrimental to the study and subject's overall well-being.
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Exclusion

    Key Trial Info

    Start Date :

    January 23 2022

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    January 9 2024

    Estimated Enrollment :

    100 Patients enrolled

    Trial Details

    Trial ID

    NCT05283525

    Start Date

    January 23 2022

    End Date

    January 9 2024

    Last Update

    March 17 2022

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Dr Bruce S. Morrison

    Huntingdon Valley, Pennsylvania, United States, 19006