Clinical trial NCT05283525: Efficacy Of Trimrox On Body Recomposition And Weight Management (TRCAP21)
Official title: Efficacy Of Trimrox On Body Composition, Body Weight, And Anthropometric Parameters In 100 Healthy Male And Female Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Body Weight Changes
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
Lead sponsor: Victory Nutrition International, Inc.
Sponsor class: INDUSTRY
First posted: 2022-03-17
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Longitudinal Study To Determine The Efficacy of Trimrox Efficacy On Body Recomposition And Weight Management In Human Volunteers
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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.

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Primary outcomes:
measure: Anthropometric Measurement of the Chest (in Inches)
timeFrame: 0 Day of Treatment
measure: Anthropometric Measurement of the Chest (in Inches)
timeFrame: 30 Day of Treatment
measure: Anthropometric Measurement of the Chest (in Inches)
timeFrame: 60 Day of Treatment
measure: Anthropometric Measurement of the Chest (in Inches)
timeFrame: 90 Days of Treatment
measure: Anthropometric Measurement of the Upper Arm/Bicep (in Inches)
timeFrame: 0 Day of Treatment
measure: Anthropometric Measurement of the Upper Arm/Bicep (in Inches)
timeFrame: 30 Days of Treatment
measure: Anthropometric Measurement of the Upper Arm/Bicep (in Inches)
timeFrame: 60 Days of Treatment
measure: Anthropometric Measurement of the Upper Arm/Bicep (in Inches)
timeFrame: 90 Days of Treatment
measure: Anthropometric Measurement of the Hip (in Inches)
timeFrame: 0 Day of Treatment
measure: Anthropometric Measurement of the Hip (in Inches)
timeFrame: 30 Days of Treatment
measure: Anthropometric Measurement of the Hip (in Inches)
timeFrame: 60 Days of Treatment
measure: Anthropometric Measurement of the Hip (in Inches)
timeFrame: 90 Days of Treatment
measure: Anthropometric Measurement of the Thighs (in Inches)
timeFrame: 0 Day of Treatment
measure: Anthropometric Measurement of the Thighs (in Inches)
timeFrame: 30 Days of Treatment
measure: Anthropometric Measurement of the Thighs (in Inches)
timeFrame: 60 Days of Treatment
measure: Anthropometric Measurement of the Thighs (in Inches)
timeFrame: 90 Days of Treatment
measure: Anthropometric Measurement of the Waist/Belly (in Inches)
timeFrame: 0 Day of Treatment
measure: Anthropometric Measurement of the Waist/Belly (in Inches)
timeFrame: 30 Days of Treatment
measure: Anthropometric Measurement of the Waist/Belly (in Inches)
timeFrame: 60 Days of Treatment
measure: Anthropometric Measurement of the Waist/Belly (in Inches)
timeFrame: 90 Days of Treatment
measure: Body Weight Measurement (in Kilograms)
timeFrame: 0 Day of Treatment
measure: Body Weight Measurement (in Kilograms)
timeFrame: 30 Days of Treatment
measure: Body Weight Measurement (in Kilograms)
timeFrame: 60 Days of Treatment
measure: Body Weight Measurement (in Kilograms)
timeFrame: 90 Days of Treatment
measure: Height Measurement (in Centimeters)
timeFrame: 0 Day of Treatment
measure: Height Measurement (in Centimeters)
timeFrame: 30 Days of Treatment
measure: Height Measurement (in Centimeters)
timeFrame: 60 Days of Treatment
measure: Height Measurement (in Centimeters)
timeFrame: 90 Days of Treatment
measure: BMI (body mass index) Measurement (in kg/m^2)
timeFrame: 0 Day of Treatment
measure: BMI (body mass index) Measurement (in kg/m^2)
timeFrame: 30 Days of Treatment
measure: BMI (body mass index) Measurement (in kg/m^2)
timeFrame: 60 Days of Treatment
measure: BMI (body mass index) Measurement (in kg/m^2)
timeFrame: 90 Days of Treatment
Secondary outcomes:
measure: Systolic and Diastolic Blood Pressure Measurements (in mmHg)
timeFrame: 0 Day of Treatment
measure: Systolic and Diastolic Blood Pressure Measurements (in mmHg)
timeFrame: 30 Days of Treatment
measure: Systolic and Diastolic Blood Pressure Measurements (in mmHg)
timeFrame: 60 Days of Treatment
measure: Systolic and Diastolic Blood Pressure Measurements (in mmHg)
timeFrame: 90 Days of Treatment
measure: Pulse Rate Measurement (in beats per minute; bpm)
timeFrame: 0 Day of Treatment
measure: Pulse Rate Measurement (in beats per minute; bpm)
timeFrame: 30 Days of Treatment
measure: Pulse Rate Measurement (in beats per minute; bpm)
timeFrame: 60 Days of Treatment
measure: Pulse Rate Measurement (in beats per minute; bpm)
timeFrame: 90 Days of Treatment
measure: Saturation of Oxygen in Red Blood Cells (Pulse Ox Measurements; SpO2%)
timeFrame: 0 Day of Treatment
measure: Saturation of Oxygen in Red Blood Cells (Pulse Ox Measurements; SpO2%)
timeFrame: 30 Days of Treatment
measure: Saturation of Oxygen in Red Blood Cells (Pulse Ox Measurements; SpO2%)
timeFrame: 60 Days of Treatment
measure: Saturation of Oxygen in Red Blood Cells (Pulse Ox Measurements; SpO2%)
timeFrame: 90 Days of Treatment
Other outcomes:
Locations:
city: Huntingdon Valley
country: United States
facility: Dr Bruce S. Morrison
state: Pennsylvania
Study officials:
References: