Recruiting

Trimrox

Sponsor:

Victory Nutrition International, Inc.

Code:

NCT05283525

Conditions

Body Weight Changes

Eligibility Criteria

Sex: All

Age: 30 - 70

Healthy Volunteers: Accepted

Interventions

Anthropometric Measurement of the Chest, Upper Arm/Bicep, Hips, Thighs and Waist/ Belly in Inches

Oxygen Saturation

Total Blood Chemistry

Adverse Event Monitoring

Body Weight Monitoring

Study Details

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 that is CFR-111 A compliant as well as having a BRC A rating, ensuring compliance with the Global Food Safety Initiative (GFSI). The investigators developed a stimulant- and sugar-free TRCAP21 Prodosomed® nutraceutical technology that effectively addresses directly and indirectly all the contributing factors. The investigators will conduct a 90-day study investigation in 100 study participants to assess the efficacy of TRCAP21 on diverse anthropometric aspects including chest, upper arms, waist/belly, hips and thighs, body weight, height, body mass index (BMI), and overall health and well-being.

Conditions

Body Weight Changes

Study ID

NCT05283525

Start date

Jan 23, 2022

Status verified date

Feb, 2022

Completion date

Jan 9, 2024

Anticipated

Primary completion date

Feb 28, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 70

Healthy Volunteers: Accepted

Inclusion Criteria

1. Agrees to sign written and audio-visual informed consent.
2. Fully understand the risks and benefits of the study
3. Male and Female Subjects (age: 30-70 Y)
4. Subjects are deemed to be acceptable for this study by their physician

Exclusion Criteria

1. Subjects who are unwilling or uncooperative subjects
2. Subjects were excluded who had impaired hepatic functions i,e., SGOT/SGPT >2.5 X
3. Subjects suffering from type 1 diabetes
4. Subjects suffering from type 2 diabetes or anyone else that has a blood glucose levels >180 mg/dl or HbA1c > 8.
5. Subjects who were suffering from coronary artery disease or high blood pressure >180/100
6. 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
7. Subjects who have cancer and are suffering from a malignancy.
8. Hypersensitivity to the investigational supplement
9. Subjects who had used any known weight management supplement for the last 2 months.
10. History of blood coagulation and bleeding (coagulopathies)
11. Incidence of high alcohol intake (more than 2 standard drinks/day).
12. Psychiatric disorder/disability provide signed informed consent.
13. Existing medical condition of the participant, which may be detrimental to the study and subject's overall well-being.

__________________________________________________________________

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

placebo comparator: Placebo Group #1 (6.75 gms Once-A-Day)

Placebo Group #1 (1 Dose; 6.75 gms per day): A total of 25 subjects will be given 1 placebo sachet; To be taken one in the morning in an empty stomach over a period of 90 consecutive days

placebo comparator: Placebo Group #2 (6.75 gms Twice-A-Day)

Placebo Group #2 (2 Doses; 13.5 gms in two divided doses per day): A total of 25 subjects will be given 2 placebo sachets; To be taken one in the morning in an empty stomach and the other in the afternoon in an empty stomach over a period of 90 consecutive days

active comparator: TRCAP21 Group #1 (6.75 gms Once-A-Day)

TRCAP21 Group #1 (1 Dose; 6.75 gms per day): A total of 25 subjects will be given 1 TRCAP21 sachet; To be taken one in the morning in an empty stomach over a period of 90 consecutive days

active comparator: TRCAP21 Group #2 (6.75 gms Twice-A-Day)

TRCAP21 Group #2 (2 Doses; 13.5 gms in two divided doses per day): A total of 25 subjects will be given 2 TRCAP21 sachets; To be taken one in the morning in empty stomach and the other in the afternoon in an empty stomach over a period of 90 consecutive days

Interventions

Anthropometric Measurement of the Chest, Upper Arm/Bicep, Hips, Thighs and Waist/ Belly in Inches

0 - 90 Days of Treatment

Oxygen Saturation

0 - 90 Days of Treatment

Total Blood Chemistry

0 and 90 Days of Treatment

Adverse Event Monitoring

Adverse Event Monitoring Throughout the Study

Body Weight Monitoring

0 - 90 Days of Treatment

Physical well-being including mood, energy, satiety level. sugar cravings, sleep, and overall health

0 - 90 Days of Treatment

Primary outcome measure

  • Anthropometric Measurement of the Chest (in Inches) [ Time Frame: 0 Day of Treatment ]
  • Anthropometric Measurement of the Chest (in Inches) [ Time Frame: 30 Day of Treatment ]
  • Anthropometric Measurement of the Chest (in Inches) [ Time Frame: 60 Day of Treatment ]
  • Anthropometric Measurement of the Chest (in Inches) [ Time Frame: 90 Days of Treatment ]
  • Anthropometric Measurement of the Upper Arm/Bicep (in Inches) [ Time Frame: 0 Day of Treatment ]
  • Anthropometric Measurement of the Upper Arm/Bicep (in Inches) [ Time Frame: 30 Days of Treatment ]
  • Anthropometric Measurement of the Upper Arm/Bicep (in Inches) [ Time Frame: 60 Days of Treatment ]
  • Anthropometric Measurement of the Upper Arm/Bicep (in Inches) [ Time Frame: 90 Days of Treatment ]
  • Anthropometric Measurement of the Hip (in Inches) [ Time Frame: 0 Day of Treatment ]
  • Anthropometric Measurement of the Hip (in Inches) [ Time Frame: 30 Days of Treatment ]
  • Anthropometric Measurement of the Hip (in Inches) [ Time Frame: 60 Days of Treatment ]
  • Anthropometric Measurement of the Hip (in Inches) [ Time Frame: 90 Days of Treatment ]
  • Anthropometric Measurement of the Thighs (in Inches) [ Time Frame: 0 Day of Treatment ]
  • Anthropometric Measurement of the Thighs (in Inches) [ Time Frame: 30 Days of Treatment ]
  • Anthropometric Measurement of the Thighs (in Inches) [ Time Frame: 60 Days of Treatment ]
  • Anthropometric Measurement of the Thighs (in Inches) [ Time Frame: 90 Days of Treatment ]
  • Anthropometric Measurement of the Waist/Belly (in Inches) [ Time Frame: 0 Day of Treatment ]
  • Anthropometric Measurement of the Waist/Belly (in Inches) [ Time Frame: 30 Days of Treatment ]
  • Anthropometric Measurement of the Waist/Belly (in Inches) [ Time Frame: 60 Days of Treatment ]
  • Anthropometric Measurement of the Waist/Belly (in Inches) [ Time Frame: 90 Days of Treatment ]
  • Body Weight Measurement (in Kilograms) [ Time Frame: 0 Day of Treatment ]
  • Body Weight Measurement (in Kilograms) [ Time Frame: 30 Days of Treatment ]
  • Body Weight Measurement (in Kilograms) [ Time Frame: 60 Days of Treatment ]
  • Body Weight Measurement (in Kilograms) [ Time Frame: 90 Days of Treatment ]
  • Height Measurement (in Centimeters) [ Time Frame: 0 Day of Treatment ]
  • Height Measurement (in Centimeters) [ Time Frame: 30 Days of Treatment ]
  • Height Measurement (in Centimeters) [ Time Frame: 60 Days of Treatment ]
  • Height Measurement (in Centimeters) [ Time Frame: 90 Days of Treatment ]
  • BMI (body mass index) Measurement (in kg/m^2) [ Time Frame: 0 Day of Treatment ]
  • BMI (body mass index) Measurement (in kg/m^2) [ Time Frame: 30 Days of Treatment ]
  • BMI (body mass index) Measurement (in kg/m^2) [ Time Frame: 60 Days of Treatment ]
  • BMI (body mass index) Measurement (in kg/m^2) [ Time Frame: 90 Days of Treatment ]

Central Contacts and Locations

Central contacts

DR DEBASIS BAGCHI, PhD

19259486951debasisbagchi@gmail.com

Locations

Dr Bruce S. Morrison

Recruiting

Huntingdon Valley, Pennsylvania, United States, 19006

Contacts

Bruce S Morrison, DO

215-947-9131drmorrisonfm@gmail.com

More Information

Sponsor

Victory Nutrition International, Inc.

Last update posted

Mar 17, 2022

Last verified

Feb, 2022

Keywords

  • TrimRox (TRCAP21)
  • 90-Day Investigation
  • 100 Subjects
  • Body Weight, Height, Body Mass Index (BMI)
  • Blood Pressure
  • Anthropometric Measurement
  • Body Composition
  • Oxygen Saturation
  • Adverse Event Monitoring

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Victory Nutrition International, Inc. on 2022-03-17.