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

Sponsor

Victory Nutrition International, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05283525

Collaborator

(none)

100

Enrollment

Location

Arms

23.5

Anticipated Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

Anticipated 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 VolunteersA 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 :

Jan 23, 2022

Anticipated Primary Completion Date :

Feb 28, 2023

Anticipated Study Completion Date :

Jan 9, 2024

Arms and Interventions

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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: Physical well-being

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Systolic and Diastolic Blood Pressure Measurements (in mmHg) [0 Day of Treatment]
Systolic and Diastolic Blood Pressure Measurements (mmHg)
Systolic and Diastolic Blood Pressure Measurements (in mmHg) [30 Days of Treatment]
Systolic and Diastolic Blood Pressure Measurements (mmHg)
Systolic and Diastolic Blood Pressure Measurements (in mmHg) [60 Days of Treatment]
Systolic and Diastolic Blood Pressure Measurements (mmHg)
Systolic and Diastolic Blood Pressure Measurements (in mmHg) [90 Days of Treatment]
Systolic and Diastolic Blood Pressure Measurements (mmHg)
Pulse Rate Measurement (in beats per minute; bpm) [0 Day of Treatment]
Pulse Rate (beats per minute; bpm)
Pulse Rate Measurement (in beats per minute; bpm) [30 Days of Treatment]
Pulse Rate (beats per minute; bpm)
Pulse Rate Measurement (in beats per minute; bpm) [60 Days of Treatment]
Pulse Rate (beats per minute; bpm)
Pulse Rate Measurement (in beats per minute; bpm) [90 Days of Treatment]
Pulse Rate (beats per minute; bpm)
Saturation of Oxygen in Red Blood Cells (Pulse Ox Measurements; SpO2%) [0 Day of Treatment]
Pulse Ox Measurement (SpO2%)
Saturation of Oxygen in Red Blood Cells (Pulse Ox Measurements; SpO2%) [30 Days of Treatment]
Pulse Ox Measurement (SpO2%)
Saturation of Oxygen in Red Blood Cells (Pulse Ox Measurements; SpO2%) [60 Days of Treatment]
Pulse Ox Measurement (SpO2%)
Saturation of Oxygen in Red Blood Cells (Pulse Ox Measurements; SpO2%) [90 Days of Treatment]
Pulse Ox Measurement (SpO2%)

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.