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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05283525
Recruitment Status : Recruiting
First Posted : March 17, 2022
Last Update Posted : March 17, 2022
Sponsor:
Information provided by (Responsible Party):
Victory Nutrition International, Inc.

Study Description
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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.


Condition or disease Intervention/treatment Phase
Body Weight Changes Dietary Supplement: Anthropometric Measurement of the Chest, Upper Arm/Bicep, Hips, Thighs and Waist/ Belly in Inches Dietary Supplement: Oxygen Saturation Dietary Supplement: Total Blood Chemistry Dietary Supplement: Adverse Event Monitoring Dietary Supplement: Body Weight Monitoring Dietary Supplement: Physical well-being including mood, energy, satiety level. sugar cravings, sleep, and overall health Not Applicable

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 emphasized that 49.6% of non-Hispanic Black adults exhibited the highest age-adjusted prevalence of obesity, which is followed by the occurrence of 44.8% in Hispanic adults, 42.2% in non-Hispanic White adults, and 17.4% in non-Hispanic Asian adults. Obesity-related conditions include diverse cardiovascular diseases and dysfunctions, stroke, Type 2 Diabetes, and certain types of cancer that are some of the leading causes of preventable, premature death. The estimated annual medical cost of obesity in the United States was $147 billion in 2008 US dollars; the medical cost for people who have obesity was $1,429 higher than those of normal weight. Overall, the obesity epidemic is increasing at an alarming rate worldwide. Because of the alarming rise in the global obesity epidemic, the terminologies "weight loss" and "weight management" have become common descriptors, even in the medical and scientific communities. However, the correct scientific terminology should more accurately refer to express changes in body composition and size, especially in regard to a reduction in fat mass, rather than weight reduction alone. In fact, the investigators will demonstrate that focusing on "weight" as an appropriate measuring criterion constitutes a contradiction and a misconception to the natural sequence of metabolic events in the body recomposition process. Overall, the term 'weight loss' is an unreliable metric as it automatically places the primary focus on the heaviness of the body and does not provide a correct and accurate perspective for evaluating healthy changes in metabolism, body composition, or size. For example, losing a small amount of fat while increasing muscle density, strength, and performance could result in a small increase in weight, as muscle is heavier than fat. It is especially important to highlight that fat is the lightest of pertinent macro molecules in the human body, lighter than water, muscle mass, and bone. Moreover, fat is usually 'the last to go' in the body recomposition process, therefore, creating short-term expectations in weight loss is erroneous and maybe even fraudulent.

A more comprehensive and accurate approach therefore is to fundamentally restore healthy efficient aerobic metabolism, improving oxygen utilization and management that enables competent cellular waste removal. Adversarial factors to that objective involve nutrient deprivation (the most common factor employed by weight loss products and programs), the imposition of various types of stimulants inducing, via feedback, regulatory energy-conserving retaliation in the form of even greater survival insurance storage; triggering the "yo-yo" rebound weight regain. Moreover, conventional weight loss tactics seem to ignore the biological, genetic, and metabolic consequences that occur with aging. Diminishing hormonal potencies are crucially important considerations that need to be addressed in the obesity epidemic. Cellular oxygen deprivation-induced anaerobic pathologies exacerbate and amplify the effects of diminished hormone functionality and contribute to an increasingly sluggish metabolism with increased fat, glycogen, and water storage. This also increases the detrimental strain on the cardiovascular system, kidneys, GI tract, and microbiome to name a few. The objective is to restore optimal systemic aerobic metabolism using a novel TRCAP21 nutraceutical formulation that addresses multiple biological pathways in order to reduce survival panic, restore survival safety, and correct metabolic homeostasis.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A Longitudinal Study To Determine The Efficacy of Trimrox Efficacy On Body Recomposition And Weight Management In Human Volunteers
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: This is a double-blind placebo-controlled study. An independent body will randomize the study subjects and determine the placebo- and treatment group subjects
Primary Purpose: Supportive Care
Official Title: Efficacy Of Trimrox On Body Composition, Body Weight, And Anthropometric Parameters In 100 Healthy Male And Female Volunteers
Actual Study Start Date : January 23, 2022
Estimated Primary Completion Date : February 28, 2023
Estimated Study Completion Date : January 9, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arms and Interventions
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Arm Intervention/treatment
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
 Dietary Supplement: Anthropometric Measurement of the Chest, Upper Arm/Bicep, Hips, Thighs and Waist/ Belly in Inches
0 - 90 Days of Treatment
Other Name: Anthropometric Measurements

Dietary Supplement: Oxygen Saturation
0 - 90 Days of Treatment

Dietary Supplement: Total Blood Chemistry
0 and 90 Days of Treatment

Dietary Supplement: Adverse Event Monitoring
Adverse Event Monitoring Throughout the Study

Dietary Supplement: Body Weight Monitoring
0 - 90 Days of Treatment
Other Name: Adverse Event Monitoring in All Groups

Dietary Supplement: Physical well-being including mood, energy, satiety level. sugar cravings, sleep, and overall health
0 - 90 Days of Treatment
Other Name: Physical well-being
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
 Dietary Supplement: Anthropometric Measurement of the Chest, Upper Arm/Bicep, Hips, Thighs and Waist/ Belly in Inches
0 - 90 Days of Treatment
Other Name: Anthropometric Measurements

Dietary Supplement: Oxygen Saturation
0 - 90 Days of Treatment

Dietary Supplement: Total Blood Chemistry
0 and 90 Days of Treatment

Dietary Supplement: Adverse Event Monitoring
Adverse Event Monitoring Throughout the Study

Dietary Supplement: Body Weight Monitoring
0 - 90 Days of Treatment
Other Name: Adverse Event Monitoring in All Groups

Dietary Supplement: Physical well-being including mood, energy, satiety level. sugar cravings, sleep, and overall health
0 - 90 Days of Treatment
Other Name: Physical well-being
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
 Dietary Supplement: Anthropometric Measurement of the Chest, Upper Arm/Bicep, Hips, Thighs and Waist/ Belly in Inches
0 - 90 Days of Treatment
Other Name: Anthropometric Measurements

Dietary Supplement: Oxygen Saturation
0 - 90 Days of Treatment

Dietary Supplement: Total Blood Chemistry
0 and 90 Days of Treatment

Dietary Supplement: Adverse Event Monitoring
Adverse Event Monitoring Throughout the Study

Dietary Supplement: Body Weight Monitoring
0 - 90 Days of Treatment
Other Name: Adverse Event Monitoring in All Groups

Dietary Supplement: Physical well-being including mood, energy, satiety level. sugar cravings, sleep, and overall health
0 - 90 Days of Treatment
Other Name: Physical well-being
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
 Dietary Supplement: Anthropometric Measurement of the Chest, Upper Arm/Bicep, Hips, Thighs and Waist/ Belly in Inches
0 - 90 Days of Treatment
Other Name: Anthropometric Measurements

Dietary Supplement: Oxygen Saturation
0 - 90 Days of Treatment

Dietary Supplement: Total Blood Chemistry
0 and 90 Days of Treatment

Dietary Supplement: Adverse Event Monitoring
Adverse Event Monitoring Throughout the Study

Dietary Supplement: Body Weight Monitoring
0 - 90 Days of Treatment
Other Name: Adverse Event Monitoring in All Groups

Dietary Supplement: Physical well-being including mood, energy, satiety level. sugar cravings, sleep, and overall health
0 - 90 Days of Treatment
Other Name: Physical well-being


Outcome Measures
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Primary Outcome Measures :
  1. Anthropometric Measurement of the Chest (in Inches) [ Time Frame: 0 Day of Treatment ]
    Anthropometric Measurement of the Chest (in Inches)

  2. Anthropometric Measurement of the Chest (in Inches) [ Time Frame: 30 Day of Treatment ]
    Anthropometric Measurement of the Chest (in Inches)

  3. Anthropometric Measurement of the Chest (in Inches) [ Time Frame: 60 Day of Treatment ]
    Anthropometric Measurement of the Chest (in Inches)

  4. Anthropometric Measurement of the Chest (in Inches) [ Time Frame: 90 Days of Treatment ]
    Anthropometric Measurement of the Chest (in Inches)

  5. Anthropometric Measurement of the Upper Arm/Bicep (in Inches) [ Time Frame: 0 Day of Treatment ]
    Anthropometric Measurement of the Upper Arm/Bicep (in Inches)

  6. Anthropometric Measurement of the Upper Arm/Bicep (in Inches) [ Time Frame: 30 Days of Treatment ]
    Anthropometric Measurement of the Upper Arm/Bicep (in Inches)

  7. Anthropometric Measurement of the Upper Arm/Bicep (in Inches) [ Time Frame: 60 Days of Treatment ]
    Anthropometric Measurement of the Upper Arm/Bicep (in Inches)

  8. Anthropometric Measurement of the Upper Arm/Bicep (in Inches) [ Time Frame: 90 Days of Treatment ]
    Anthropometric Measurement of the Upper Arm/Bicep (in Inches)

  9. Anthropometric Measurement of the Hip (in Inches) [ Time Frame: 0 Day of Treatment ]
    Anthropometric Measurements of the Hip (in Inches)

  10. Anthropometric Measurement of the Hip (in Inches) [ Time Frame: 30 Days of Treatment ]
    Anthropometric Measurements of the Hip (in Inches)

  11. Anthropometric Measurement of the Hip (in Inches) [ Time Frame: 60 Days of Treatment ]
    Anthropometric Measurements of the Hip (in Inches)

  12. Anthropometric Measurement of the Hip (in Inches) [ Time Frame: 90 Days of Treatment ]
    Anthropometric Measurements of the Hip (in Inches)

  13. Anthropometric Measurement of the Thighs (in Inches) [ Time Frame: 0 Day of Treatment ]
    Anthropometric Measurement of the Thighs (in Inches)

  14. Anthropometric Measurement of the Thighs (in Inches) [ Time Frame: 30 Days of Treatment ]
    Anthropometric Measurement of the Thighs (in Inches)

  15. Anthropometric Measurement of the Thighs (in Inches) [ Time Frame: 60 Days of Treatment ]
    Anthropometric Measurement of the Thighs (in Inches)

  16. Anthropometric Measurement of the Thighs (in Inches) [ Time Frame: 90 Days of Treatment ]
    Anthropometric Measurement of the Thighs (in Inches)

  17. Anthropometric Measurement of the Waist/Belly (in Inches) [ Time Frame: 0 Day of Treatment ]
    Anthropometric Measurements of the Waist/Belly (in Inches)

  18. Anthropometric Measurement of the Waist/Belly (in Inches) [ Time Frame: 30 Days of Treatment ]
    Anthropometric Measurements of the Waist/Belly (in Inches)

  19. Anthropometric Measurement of the Waist/Belly (in Inches) [ Time Frame: 60 Days of Treatment ]
    Anthropometric Measurements of the Waist/Belly (in Inches)

  20. Anthropometric Measurement of the Waist/Belly (in Inches) [ Time Frame: 90 Days of Treatment ]
    Anthropometric Measurements of the Waist/Belly (in Inches)

  21. Body Weight Measurement (in Kilograms) [ Time Frame: 0 Day of Treatment ]
    Body Weight Measurements (in Kilograms)

  22. Body Weight Measurement (in Kilograms) [ Time Frame: 30 Days of Treatment ]
    Body Weight Measurements (in Kilograms)

  23. Body Weight Measurement (in Kilograms) [ Time Frame: 60 Days of Treatment ]
    Body Weight Measurements (in Kilograms)

  24. Body Weight Measurement (in Kilograms) [ Time Frame: 90 Days of Treatment ]
    Body Weight Measurements (in Kilograms)

  25. Height Measurement (in Centimeters) [ Time Frame: 0 Day of Treatment ]
    Height Measurement (in Centimeters)

  26. Height Measurement (in Centimeters) [ Time Frame: 30 Days of Treatment ]
    Height Measurement (in Centimeters)

  27. Height Measurement (in Centimeters) [ Time Frame: 60 Days of Treatment ]
    Height Measurement (in Centimeters)

  28. Height Measurement (in Centimeters) [ Time Frame: 90 Days of Treatment ]
    Height Measurement (in Centimeters)

  29. BMI (body mass index) Measurement (in kg/m^2) [ Time Frame: 0 Day of Treatment ]
    BMI (body mass index)(kg/m^2)

  30. BMI (body mass index) Measurement (in kg/m^2) [ Time Frame: 30 Days of Treatment ]
    BMI (body mass index)(kg/m^2)

  31. BMI (body mass index) Measurement (in kg/m^2) [ Time Frame: 60 Days of Treatment ]
    BMI (body mass index)(kg/m^2)

  32. BMI (body mass index) Measurement (in kg/m^2) [ Time Frame: 90 Days of Treatment ]
    BMI (body mass index)(kg/m^2)


Secondary Outcome Measures :
  1. Systolic and Diastolic Blood Pressure Measurements (in mmHg) [ Time Frame: 0 Day of Treatment ]
    Systolic and Diastolic Blood Pressure Measurements (mmHg)

  2. Systolic and Diastolic Blood Pressure Measurements (in mmHg) [ Time Frame: 30 Days of Treatment ]
    Systolic and Diastolic Blood Pressure Measurements (mmHg)

  3. Systolic and Diastolic Blood Pressure Measurements (in mmHg) [ Time Frame: 60 Days of Treatment ]
    Systolic and Diastolic Blood Pressure Measurements (mmHg)

  4. Systolic and Diastolic Blood Pressure Measurements (in mmHg) [ Time Frame: 90 Days of Treatment ]
    Systolic and Diastolic Blood Pressure Measurements (mmHg)

  5. Pulse Rate Measurement (in beats per minute; bpm) [ Time Frame: 0 Day of Treatment ]
    Pulse Rate (beats per minute; bpm)

  6. Pulse Rate Measurement (in beats per minute; bpm) [ Time Frame: 30 Days of Treatment ]
    Pulse Rate (beats per minute; bpm)

  7. Pulse Rate Measurement (in beats per minute; bpm) [ Time Frame: 60 Days of Treatment ]
    Pulse Rate (beats per minute; bpm)

  8. Pulse Rate Measurement (in beats per minute; bpm) [ Time Frame: 90 Days of Treatment ]
    Pulse Rate (beats per minute; bpm)

  9. Saturation of Oxygen in Red Blood Cells (Pulse Ox Measurements; SpO2%) [ Time Frame: 0 Day of Treatment ]
    Pulse Ox Measurement (SpO2%)

  10. Saturation of Oxygen in Red Blood Cells (Pulse Ox Measurements; SpO2%) [ Time Frame: 30 Days of Treatment ]
    Pulse Ox Measurement (SpO2%)

  11. Saturation of Oxygen in Red Blood Cells (Pulse Ox Measurements; SpO2%) [ Time Frame: 60 Days of Treatment ]
    Pulse Ox Measurement (SpO2%)

  12. Saturation of Oxygen in Red Blood Cells (Pulse Ox Measurements; SpO2%) [ Time Frame: 90 Days of Treatment ]
    Pulse Ox Measurement (SpO2%)


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

    __________________________________________________________________

Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05283525


Contacts
Layout table for location contacts
Contact: DR DEBASIS BAGCHI, PhD 19259486951 debasisbagchi@gmail.com

Locations
Layout table for location information
United States, Pennsylvania
Dr Bruce S. Morrison Recruiting
Huntingdon Valley, Pennsylvania, United States, 19006
Contact: Bruce S Morrison, DO    215-947-9131    drmorrisonfm@gmail.com   
Sponsors and Collaborators
Victory Nutrition International, Inc.
More Information
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Layout table for additonal information
Responsible Party: Victory Nutrition International, Inc.
ClinicalTrials.gov Identifier: NCT05283525    
Other Study ID Numbers: VNI-TRIMROX-2022
First Posted: March 17, 2022    Key Record Dates
Last Update Posted: March 17, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: YES
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Jan 23, 2022 to Jan 22, 2023
Access Criteria: www.vni.life
URL: http://www.vni.life

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Victory Nutrition International, Inc.:
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Body Weight
Body Weight Changes