Efficacy Of Trimrox On Body Recomposition And Weight Management (TRCAP21)
VNI
Efficacy Of Trimrox On Body Composition, Body Weight, And Anthropometric Parameters In 100 Healthy Male And Female Volunteers
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2022
Typical duration for not_applicable
1 active site
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
January 10, 2022
CompletedStudy Start
First participant enrolled
January 23, 2022
CompletedFirst Posted
Study publicly available on registry
March 17, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 9, 2024
CompletedMarch 17, 2022
February 1, 2022
1.1 years
January 10, 2022
March 3, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (32)
Anthropometric Measurement of the Chest (in Inches)
Anthropometric Measurement of the Chest (in Inches)
0 Day of Treatment
Anthropometric Measurement of the Chest (in Inches)
Anthropometric Measurement of the Chest (in Inches)
30 Day of Treatment
Anthropometric Measurement of the Chest (in Inches)
Anthropometric Measurement of the Chest (in Inches)
60 Day of Treatment
Anthropometric Measurement of the Chest (in Inches)
Anthropometric Measurement of the Chest (in Inches)
90 Days of Treatment
Anthropometric Measurement of the Upper Arm/Bicep (in Inches)
Anthropometric Measurement of the Upper Arm/Bicep (in Inches)
0 Day of Treatment
Anthropometric Measurement of the Upper Arm/Bicep (in Inches)
Anthropometric Measurement of the Upper Arm/Bicep (in Inches)
30 Days of Treatment
Anthropometric Measurement of the Upper Arm/Bicep (in Inches)
Anthropometric Measurement of the Upper Arm/Bicep (in Inches)
60 Days of Treatment
Anthropometric Measurement of the Upper Arm/Bicep (in Inches)
Anthropometric Measurement of the Upper Arm/Bicep (in Inches)
90 Days of Treatment
Anthropometric Measurement of the Hip (in Inches)
Anthropometric Measurements of the Hip (in Inches)
0 Day of Treatment
Anthropometric Measurement of the Hip (in Inches)
Anthropometric Measurements of the Hip (in Inches)
30 Days of Treatment
Anthropometric Measurement of the Hip (in Inches)
Anthropometric Measurements of the Hip (in Inches)
60 Days of Treatment
Anthropometric Measurement of the Hip (in Inches)
Anthropometric Measurements of the Hip (in Inches)
90 Days of Treatment
Anthropometric Measurement of the Thighs (in Inches)
Anthropometric Measurement of the Thighs (in Inches)
0 Day of Treatment
Anthropometric Measurement of the Thighs (in Inches)
Anthropometric Measurement of the Thighs (in Inches)
30 Days of Treatment
Anthropometric Measurement of the Thighs (in Inches)
Anthropometric Measurement of the Thighs (in Inches)
60 Days of Treatment
Anthropometric Measurement of the Thighs (in Inches)
Anthropometric Measurement of the Thighs (in Inches)
90 Days of Treatment
Anthropometric Measurement of the Waist/Belly (in Inches)
Anthropometric Measurements of the Waist/Belly (in Inches)
0 Day of Treatment
Anthropometric Measurement of the Waist/Belly (in Inches)
Anthropometric Measurements of the Waist/Belly (in Inches)
30 Days of Treatment
Anthropometric Measurement of the Waist/Belly (in Inches)
Anthropometric Measurements of the Waist/Belly (in Inches)
60 Days of Treatment
Anthropometric Measurement of the Waist/Belly (in Inches)
Anthropometric Measurements of the Waist/Belly (in Inches)
90 Days of Treatment
Body Weight Measurement (in Kilograms)
Body Weight Measurements (in Kilograms)
0 Day of Treatment
Body Weight Measurement (in Kilograms)
Body Weight Measurements (in Kilograms)
30 Days of Treatment
Body Weight Measurement (in Kilograms)
Body Weight Measurements (in Kilograms)
60 Days of Treatment
Body Weight Measurement (in Kilograms)
Body Weight Measurements (in Kilograms)
90 Days of Treatment
Height Measurement (in Centimeters)
Height Measurement (in Centimeters)
0 Day of Treatment
Height Measurement (in Centimeters)
Height Measurement (in Centimeters)
30 Days of Treatment
Height Measurement (in Centimeters)
Height Measurement (in Centimeters)
60 Days of Treatment
Height Measurement (in Centimeters)
Height Measurement (in Centimeters)
90 Days of Treatment
BMI (body mass index) Measurement (in kg/m^2)
BMI (body mass index)(kg/m\^2)
0 Day of Treatment
BMI (body mass index) Measurement (in kg/m^2)
BMI (body mass index)(kg/m\^2)
30 Days of Treatment
BMI (body mass index) Measurement (in kg/m^2)
BMI (body mass index)(kg/m\^2)
60 Days of Treatment
BMI (body mass index) Measurement (in kg/m^2)
BMI (body mass index)(kg/m\^2)
90 Days of Treatment
Secondary Outcomes (12)
Systolic and Diastolic Blood Pressure Measurements (in mmHg)
0 Day of Treatment
Systolic and Diastolic Blood Pressure Measurements (in mmHg)
30 Days of Treatment
Systolic and Diastolic Blood Pressure Measurements (in mmHg)
60 Days of Treatment
Systolic and Diastolic Blood Pressure Measurements (in mmHg)
90 Days of Treatment
Pulse Rate Measurement (in beats per minute; bpm)
0 Day of Treatment
- +7 more secondary outcomes
Study Arms (4)
Placebo Group #1 (6.75 gms Once-A-Day)
PLACEBO COMPARATORPlacebo 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 Group #2 (6.75 gms Twice-A-Day)
PLACEBO COMPARATORPlacebo 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
TRCAP21 Group #1 (6.75 gms Once-A-Day)
ACTIVE COMPARATORTRCAP21 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
TRCAP21 Group #2 (6.75 gms Twice-A-Day)
ACTIVE COMPARATORTRCAP21 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
0 - 90 Days of Treatment
0 - 90 Days of Treatment
0 and 90 Days of Treatment
Adverse Event Monitoring Throughout the Study
0 - 90 Days of Treatment
0 - 90 Days of Treatment
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dr Bruce S. Morrison
Huntingdon Valley, Pennsylvania, 19006, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- This is a double-blind placebo-controlled study. An independent body will randomize the study subjects and determine the placebo- and treatment group subjects
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2022
First Posted
March 17, 2022
Study Start
January 23, 2022
Primary Completion
February 28, 2023
Study Completion
January 9, 2024
Last Updated
March 17, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Jan 23, 2022 to Jan 22, 2023
- Access Criteria
- www.vni.life
YES