Efficacy Of Trimrox On Body Recomposition And Weight Management (TRCAP21)
- Conditions
- Body Weight Changes
- Interventions
- Dietary Supplement: Anthropometric Measurement of the Chest, Upper Arm/Bicep, Hips, Thighs and Waist/ Belly in InchesDietary Supplement: Oxygen SaturationDietary Supplement: Total Blood ChemistryDietary Supplement: Adverse Event MonitoringDietary Supplement: Body Weight MonitoringDietary Supplement: Physical well-being including mood, energy, satiety level. sugar cravings, sleep, and overall health
- Registration Number
- NCT05283525
- Lead Sponsor
- Victory Nutrition International, Inc.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Group #1 (6.75 gms Once-A-Day) Total Blood Chemistry 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 Group #1 (6.75 gms Once-A-Day) Adverse Event Monitoring 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 Group #1 (6.75 gms Once-A-Day) Physical well-being including mood, energy, satiety level. sugar cravings, sleep, and overall health 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 Group #1 (6.75 gms Once-A-Day) Anthropometric Measurement of the Chest, Upper Arm/Bicep, Hips, Thighs and Waist/ Belly in Inches 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 Group #1 (6.75 gms Once-A-Day) Body Weight Monitoring 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 Group #2 (6.75 gms Twice-A-Day) Body Weight Monitoring 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 TRCAP21 Group #1 (6.75 gms Once-A-Day) Total Blood Chemistry 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 TRCAP21 Group #2 (6.75 gms Twice-A-Day) Oxygen Saturation 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 Placebo Group #1 (6.75 gms Once-A-Day) Oxygen Saturation 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 TRCAP21 Group #1 (6.75 gms Once-A-Day) Oxygen Saturation 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 TRCAP21 Group #2 (6.75 gms Twice-A-Day) Total Blood Chemistry 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 Placebo Group #2 (6.75 gms Twice-A-Day) Anthropometric Measurement of the Chest, Upper Arm/Bicep, Hips, Thighs and Waist/ Belly in Inches 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 Placebo Group #2 (6.75 gms Twice-A-Day) Oxygen Saturation 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 Placebo Group #2 (6.75 gms Twice-A-Day) Adverse Event Monitoring 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 TRCAP21 Group #1 (6.75 gms Once-A-Day) Adverse Event Monitoring 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 TRCAP21 Group #2 (6.75 gms Twice-A-Day) Anthropometric Measurement of the Chest, Upper Arm/Bicep, Hips, Thighs and Waist/ Belly in Inches 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 TRCAP21 Group #2 (6.75 gms Twice-A-Day) Body Weight Monitoring 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 Placebo Group #2 (6.75 gms Twice-A-Day) Total Blood Chemistry 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 TRCAP21 Group #1 (6.75 gms Once-A-Day) Body Weight Monitoring 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 TRCAP21 Group #2 (6.75 gms Twice-A-Day) Adverse Event Monitoring 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 TRCAP21 Group #2 (6.75 gms Twice-A-Day) Physical well-being including mood, energy, satiety level. sugar cravings, sleep, and overall health 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 Placebo Group #2 (6.75 gms Twice-A-Day) Physical well-being including mood, energy, satiety level. sugar cravings, sleep, and overall health 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 TRCAP21 Group #1 (6.75 gms Once-A-Day) Anthropometric Measurement of the Chest, Upper Arm/Bicep, Hips, Thighs and Waist/ Belly in Inches 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 TRCAP21 Group #1 (6.75 gms Once-A-Day) Physical well-being including mood, energy, satiety level. sugar cravings, sleep, and overall health 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
- Primary Outcome Measures
Name Time Method Anthropometric Measurement of the Hip (in Inches) 90 Days of Treatment Anthropometric Measurements of the Hip (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 Thighs (in Inches) 90 Days of Treatment Anthropometric Measurement of the Thighs (in Inches)
Height Measurement (in Centimeters) 90 Days of Treatment Height Measurement (in Centimeters)
Anthropometric Measurement of the Chest (in Inches) 90 Days of Treatment Anthropometric Measurement of the Chest (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) 90 Days of Treatment Body Weight Measurements (in Kilograms)
BMI (body mass index) Measurement (in kg/m^2) 90 Days of Treatment BMI (body mass index)(kg/m\^2)
- Secondary Outcome Measures
Name Time Method 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%) 90 Days of Treatment Pulse Ox Measurement (SpO2%)
Systolic and Diastolic Blood Pressure Measurements (in mmHg) 90 Days of Treatment Systolic and Diastolic Blood Pressure Measurements (mmHg)
Trial Locations
- Locations (1)
Dr Bruce S. Morrison
🇺🇸Huntingdon Valley, Pennsylvania, United States