Body Weight ChangesVNINCT05283525
Efficacy Of Trimrox On Body Recomposition And Weight Management (TRCAP21)
A study testing Anthropometric Measurement of the Chest, Upper Arm/Bicep, Hips, Thighs and Waist/ Belly in Inches, Oxygen Saturation and Total Blood Chemistry in people with Body Weight Changes, run by Victory Nutrition International, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Weight Changes
- What is being tested?
- Anthropometric Measurement of the Chest, Upper Arm/Bicep, Hips, Thighs and Waist/ Belly in Inches, Oxygen Saturation and Total Blood Chemistry
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2022to 9 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Dr Bruce S. Morrison
Huntingdon Valley, Pennsylvania, 19006
Bruce S Morrison, DO, 215-947-9131, drmorrisonfm@gmail.com
About this study
Official title: Efficacy Of Trimrox On Body Composition, Body Weight, And Anthropometric Parameters In 100 Healthy Male And Female Volunteers
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.
Read the 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.
- Conditions
- Body Weight Changes
- Being tested
- Anthropometric Measurement of the Chest, Upper Arm/Bicep, Hips, Thighs and Waist/ Belly in Inches, Oxygen Saturation, Total Blood Chemistry, Adverse Event Monitoring, Body Weight Monitoring
- 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
- Medical subject headings
- Body Weight Changes, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anthropometric Measurement of the Chest, Upper Arm/Bicep, Hips, Thighs and Waist/ Belly in InchesDietary supplement
Also called Anthropometric Measurements
0 - 90 Days of Treatment
Oxygen SaturationDietary supplement
0 - 90 Days of Treatment
Total Blood ChemistryDietary supplement
0 and 90 Days of Treatment
Adverse Event MonitoringDietary supplement
Adverse Event Monitoring Throughout the Study
Body Weight MonitoringDietary supplement
Also called Adverse Event Monitoring in All Groups
0 - 90 Days of Treatment
Physical well-being including mood, energy, satiety level. sugar cravings, sleep, and overall healthDietary supplement
Also called Physical well-being
0 - 90 Days of Treatment
| Study group | Role | What they receive |
|---|---|---|
| Placebo Group #1 (6.75 gms Once-A-Day) | Placebo comparator | 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 Receives: 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 |
| Placebo Group #2 (6.75 gms Twice-A-Day) | Placebo comparator | 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 Receives: 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 |
| TRCAP21 Group #1 (6.75 gms Once-A-Day) | Active comparator | 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 Receives: 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 |
| TRCAP21 Group #2 (6.75 gms Twice-A-Day) | Active comparator | 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anthropometric Measurement of the Chest (in Inches)
Anthropometric Measurement of the Chest (in Inches)
Measured: 0 Day of Treatment
Anthropometric Measurement of the Chest (in Inches)
Anthropometric Measurement of the Chest (in Inches)
Measured: 30 Day of Treatment
Anthropometric Measurement of the Chest (in Inches)
Anthropometric Measurement of the Chest (in Inches)
Measured: 60 Day of Treatment
Anthropometric Measurement of the Chest (in Inches)
Anthropometric Measurement of the Chest (in Inches)
Measured: 90 Days of Treatment
Anthropometric Measurement of the Upper Arm/Bicep (in Inches)
Anthropometric Measurement of the Upper Arm/Bicep (in Inches)
Measured: 0 Day of Treatment
Anthropometric Measurement of the Upper Arm/Bicep (in Inches)
Anthropometric Measurement of the Upper Arm/Bicep (in Inches)
Measured: 30 Days of Treatment
Anthropometric Measurement of the Upper Arm/Bicep (in Inches)
Anthropometric Measurement of the Upper Arm/Bicep (in Inches)
Measured: 60 Days of Treatment
Anthropometric Measurement of the Upper Arm/Bicep (in Inches)
Anthropometric Measurement of the Upper Arm/Bicep (in Inches)
Measured: 90 Days of Treatment
Anthropometric Measurement of the Hip (in Inches)
Anthropometric Measurements of the Hip (in Inches)
Measured: 0 Day of Treatment
Anthropometric Measurement of the Hip (in Inches)
Anthropometric Measurements of the Hip (in Inches)
Measured: 30 Days of Treatment
Anthropometric Measurement of the Hip (in Inches)
Anthropometric Measurements of the Hip (in Inches)
Measured: 60 Days of Treatment
Anthropometric Measurement of the Hip (in Inches)
Anthropometric Measurements of the Hip (in Inches)
Measured: 90 Days of Treatment
Anthropometric Measurement of the Thighs (in Inches)
Anthropometric Measurement of the Thighs (in Inches)
Measured: 0 Day of Treatment
Anthropometric Measurement of the Thighs (in Inches)
Anthropometric Measurement of the Thighs (in Inches)
Measured: 30 Days of Treatment
Anthropometric Measurement of the Thighs (in Inches)
Anthropometric Measurement of the Thighs (in Inches)
Measured: 60 Days of Treatment
Anthropometric Measurement of the Thighs (in Inches)
Anthropometric Measurement of the Thighs (in Inches)
Measured: 90 Days of Treatment
Anthropometric Measurement of the Waist/Belly (in Inches)
Anthropometric Measurements of the Waist/Belly (in Inches)
Measured: 0 Day of Treatment
Anthropometric Measurement of the Waist/Belly (in Inches)
Anthropometric Measurements of the Waist/Belly (in Inches)
Measured: 30 Days of Treatment
Anthropometric Measurement of the Waist/Belly (in Inches)
Anthropometric Measurements of the Waist/Belly (in Inches)
Measured: 60 Days of Treatment
Anthropometric Measurement of the Waist/Belly (in Inches)
Anthropometric Measurements of the Waist/Belly (in Inches)
Measured: 90 Days of Treatment
Body Weight Measurement (in Kilograms)
Body Weight Measurements (in Kilograms)
Measured: 0 Day of Treatment
Body Weight Measurement (in Kilograms)
Body Weight Measurements (in Kilograms)
Measured: 30 Days of Treatment
Body Weight Measurement (in Kilograms)
Body Weight Measurements (in Kilograms)
Measured: 60 Days of Treatment
Body Weight Measurement (in Kilograms)
Body Weight Measurements (in Kilograms)
Measured: 90 Days of Treatment
Height Measurement (in Centimeters)
Height Measurement (in Centimeters)
Measured: 0 Day of Treatment
Height Measurement (in Centimeters)
Height Measurement (in Centimeters)
Measured: 30 Days of Treatment
Height Measurement (in Centimeters)
Height Measurement (in Centimeters)
Measured: 60 Days of Treatment
Height Measurement (in Centimeters)
Height Measurement (in Centimeters)
Measured: 90 Days of Treatment
BMI (body mass index) Measurement (in kg/m^2)
BMI (body mass index)(kg/m^2)
Measured: 0 Day of Treatment
BMI (body mass index) Measurement (in kg/m^2)
BMI (body mass index)(kg/m^2)
Measured: 30 Days of Treatment
BMI (body mass index) Measurement (in kg/m^2)
BMI (body mass index)(kg/m^2)
Measured: 60 Days of Treatment
BMI (body mass index) Measurement (in kg/m^2)
BMI (body mass index)(kg/m^2)
Measured: 90 Days of Treatment
Secondary outcomes (12)
Systolic and Diastolic Blood Pressure Measurements (in mmHg)
Systolic and Diastolic Blood Pressure Measurements (mmHg)
Measured: 0 Day of Treatment
Systolic and Diastolic Blood Pressure Measurements (in mmHg)
Systolic and Diastolic Blood Pressure Measurements (mmHg)
Measured: 30 Days of Treatment
Systolic and Diastolic Blood Pressure Measurements (in mmHg)
Systolic and Diastolic Blood Pressure Measurements (mmHg)
Measured: 60 Days of Treatment
Systolic and Diastolic Blood Pressure Measurements (in mmHg)
Systolic and Diastolic Blood Pressure Measurements (mmHg)
Measured: 90 Days of Treatment
Pulse Rate Measurement (in beats per minute; bpm)
Pulse Rate (beats per minute; bpm)
Measured: 0 Day of Treatment
Pulse Rate Measurement (in beats per minute; bpm)
Pulse Rate (beats per minute; bpm)
Measured: 30 Days of Treatment
Pulse Rate Measurement (in beats per minute; bpm)
Pulse Rate (beats per minute; bpm)
Measured: 60 Days of Treatment
Pulse Rate Measurement (in beats per minute; bpm)
Pulse Rate (beats per minute; bpm)
Measured: 90 Days of Treatment
Saturation of Oxygen in Red Blood Cells (Pulse Ox Measurements; SpO2%)
Pulse Ox Measurement (SpO2%)
Measured: 0 Day of Treatment
Saturation of Oxygen in Red Blood Cells (Pulse Ox Measurements; SpO2%)
Pulse Ox Measurement (SpO2%)
Measured: 30 Days of Treatment
Saturation of Oxygen in Red Blood Cells (Pulse Ox Measurements; SpO2%)
Pulse Ox Measurement (SpO2%)
Measured: 60 Days of Treatment
Saturation of Oxygen in Red Blood Cells (Pulse Ox Measurements; SpO2%)
Pulse Ox Measurement (SpO2%)
Measured: 90 Days of Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start23 Jan 2022
- Primary completion28 Feb 2023 (estimated)
- Study completion9 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Weight ChangesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Longitudinal Study To Determine The Efficacy of Trimrox Efficacy On Body Recomposition And Weight Management In Human Volunteers
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Victory Nutrition International, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05283525
- Sponsor's protocol ID
- VNI-TRIMROX-2022
- Acronym
- VNI
- Status last verified
- Feb 2022
- First submitted
- 10 Jan 2022
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: YES
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Of Trimrox On Body Composition, Body Weight, And Anthropometric Parameters In 100 Healthy Male And Female Volunteers
- ClinicalTrials.gov ID
- NCT05283525
- Acronym / sponsor ID
- VNI / VNI-TRIMROX-2022
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Victory Nutrition International, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Jan 2022 (actual)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 9 Jan 2024 (estimated)
- First posted
- 17 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- A Longitudinal Study To Determine The Efficacy of Trimrox Efficacy On Body Recomposition And Weight Management In Human Volunteers
| Arm | Type | Receives |
|---|---|---|
| Placebo Group #1 (6.75 gms Once-A-Day) | Placebo comparator | 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 healthPlacebo 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 comparator | 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 healthPlacebo 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 comparator | 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 healthTRCAP21 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 comparator | 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 healthTRCAP21 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 |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anthropometric Measurement of the Chest, Upper Arm/Bicep, Hips, Thighs and Waist/ Belly in InchesAlso: Anthropometric Measurements0 - 90 Days of Treatment | Dietary supplement | Placebo Group #1 (6.75 gms Once-A-Day), Placebo Group #2 (6.75 gms Twice-A-Day), TRCAP21 Group #1 (6.75 gms Once-A-Day), TRCAP21 Group #2 (6.75 gms Twice-A-Day) |
| Oxygen Saturation0 - 90 Days of Treatment | Dietary supplement | Placebo Group #1 (6.75 gms Once-A-Day), Placebo Group #2 (6.75 gms Twice-A-Day), TRCAP21 Group #1 (6.75 gms Once-A-Day), TRCAP21 Group #2 (6.75 gms Twice-A-Day) |
| Total Blood Chemistry0 and 90 Days of Treatment | Dietary supplement | Placebo Group #1 (6.75 gms Once-A-Day), Placebo Group #2 (6.75 gms Twice-A-Day), TRCAP21 Group #1 (6.75 gms Once-A-Day), TRCAP21 Group #2 (6.75 gms Twice-A-Day) |
| Adverse Event MonitoringAdverse Event Monitoring Throughout the Study | Dietary supplement | Placebo Group #1 (6.75 gms Once-A-Day), Placebo Group #2 (6.75 gms Twice-A-Day), TRCAP21 Group #1 (6.75 gms Once-A-Day), TRCAP21 Group #2 (6.75 gms Twice-A-Day) |
| Body Weight MonitoringAlso: Adverse Event Monitoring in All Groups0 - 90 Days of Treatment | Dietary supplement | Placebo Group #1 (6.75 gms Once-A-Day), Placebo Group #2 (6.75 gms Twice-A-Day), TRCAP21 Group #1 (6.75 gms Once-A-Day), TRCAP21 Group #2 (6.75 gms Twice-A-Day) |
| Physical well-being including mood, energy, satiety level. sugar cravings, sleep, and overall healthAlso: Physical well-being0 - 90 Days of Treatment | Dietary supplement | Placebo Group #1 (6.75 gms Once-A-Day), Placebo Group #2 (6.75 gms Twice-A-Day), TRCAP21 Group #1 (6.75 gms Once-A-Day), TRCAP21 Group #2 (6.75 gms Twice-A-Day) |
Primary outcome
Anthropometric Measurement of the Chest (in Inches)
Time frame: 0 Day of Treatment
Anthropometric Measurement of the Chest (in Inches)
Anthropometric Measurement of the Chest (in Inches)
Time frame: 30 Day of Treatment
Anthropometric Measurement of the Chest (in Inches)
Anthropometric Measurement of the Chest (in Inches)
Time frame: 60 Day of Treatment
Anthropometric Measurement of the Chest (in Inches)
Anthropometric Measurement of the Chest (in Inches)
Time frame: 90 Days of Treatment
Anthropometric Measurement of the Chest (in Inches)
Anthropometric Measurement of the Upper Arm/Bicep (in Inches)
Time frame: 0 Day of Treatment
Anthropometric Measurement of the Upper Arm/Bicep (in Inches)
Anthropometric Measurement of the Upper Arm/Bicep (in Inches)
Time frame: 30 Days of Treatment
Anthropometric Measurement of the Upper Arm/Bicep (in Inches)
Anthropometric Measurement of the Upper Arm/Bicep (in Inches)
Time frame: 60 Days of Treatment
Anthropometric Measurement of the Upper Arm/Bicep (in Inches)
Anthropometric Measurement of the Upper Arm/Bicep (in Inches)
Time frame: 90 Days of Treatment
Anthropometric Measurement of the Upper Arm/Bicep (in Inches)
Anthropometric Measurement of the Hip (in Inches)
Time frame: 0 Day of Treatment
Anthropometric Measurements of the Hip (in Inches)
Anthropometric Measurement of the Hip (in Inches)
Time frame: 30 Days of Treatment
Anthropometric Measurements of the Hip (in Inches)
Anthropometric Measurement of the Hip (in Inches)
Time frame: 60 Days of Treatment
Anthropometric Measurements of the Hip (in Inches)
Anthropometric Measurement of the Hip (in Inches)
Time frame: 90 Days of Treatment
Anthropometric Measurements of the Hip (in Inches)
Anthropometric Measurement of the Thighs (in Inches)
Time frame: 0 Day of Treatment
Anthropometric Measurement of the Thighs (in Inches)
Anthropometric Measurement of the Thighs (in Inches)
Time frame: 30 Days of Treatment
Anthropometric Measurement of the Thighs (in Inches)
Anthropometric Measurement of the Thighs (in Inches)
Time frame: 60 Days of Treatment
Anthropometric Measurement of the Thighs (in Inches)
Anthropometric Measurement of the Thighs (in Inches)
Time frame: 90 Days of Treatment
Anthropometric Measurement of the Thighs (in Inches)
Anthropometric Measurement of the Waist/Belly (in Inches)
Time frame: 0 Day of Treatment
Anthropometric Measurements of the Waist/Belly (in Inches)
Anthropometric Measurement of the Waist/Belly (in Inches)
Time frame: 30 Days of Treatment
Anthropometric Measurements of the Waist/Belly (in Inches)
Anthropometric Measurement of the Waist/Belly (in Inches)
Time frame: 60 Days of Treatment
Anthropometric Measurements of the Waist/Belly (in Inches)
Anthropometric Measurement of the Waist/Belly (in Inches)
Time frame: 90 Days of Treatment
Anthropometric Measurements of the Waist/Belly (in Inches)
Body Weight Measurement (in Kilograms)
Time frame: 0 Day of Treatment
Body Weight Measurements (in Kilograms)
Body Weight Measurement (in Kilograms)
Time frame: 30 Days of Treatment
Body Weight Measurements (in Kilograms)
Body Weight Measurement (in Kilograms)
Time frame: 60 Days of Treatment
Body Weight Measurements (in Kilograms)
Body Weight Measurement (in Kilograms)
Time frame: 90 Days of Treatment
Body Weight Measurements (in Kilograms)
Height Measurement (in Centimeters)
Time frame: 0 Day of Treatment
Height Measurement (in Centimeters)
Height Measurement (in Centimeters)
Time frame: 30 Days of Treatment
Height Measurement (in Centimeters)
Height Measurement (in Centimeters)
Time frame: 60 Days of Treatment
Height Measurement (in Centimeters)
Height Measurement (in Centimeters)
Time frame: 90 Days of Treatment
Height Measurement (in Centimeters)
BMI (body mass index) Measurement (in kg/m^2)
Time frame: 0 Day of Treatment
BMI (body mass index)(kg/m^2)
BMI (body mass index) Measurement (in kg/m^2)
Time frame: 30 Days of Treatment
BMI (body mass index)(kg/m^2)
BMI (body mass index) Measurement (in kg/m^2)
Time frame: 60 Days of Treatment
BMI (body mass index)(kg/m^2)
BMI (body mass index) Measurement (in kg/m^2)
Time frame: 90 Days of Treatment
BMI (body mass index)(kg/m^2)
12 secondary outcomes
Systolic and Diastolic Blood Pressure Measurements (in mmHg)
Time frame: 0 Day of Treatment
Systolic and Diastolic Blood Pressure Measurements (in mmHg)
Time frame: 30 Days of Treatment
Systolic and Diastolic Blood Pressure Measurements (in mmHg)
Time frame: 60 Days of Treatment
Systolic and Diastolic Blood Pressure Measurements (in mmHg)
Time frame: 90 Days of Treatment
Pulse Rate Measurement (in beats per minute; bpm)
Time frame: 0 Day of Treatment
Pulse Rate Measurement (in beats per minute; bpm)
Time frame: 30 Days of Treatment
Pulse Rate Measurement (in beats per minute; bpm)
Time frame: 60 Days of Treatment
Pulse Rate Measurement (in beats per minute; bpm)
Time frame: 90 Days of Treatment
Saturation of Oxygen in Red Blood Cells (Pulse Ox Measurements; SpO2%)
Time frame: 0 Day of Treatment
Saturation of Oxygen in Red Blood Cells (Pulse Ox Measurements; SpO2%)
Time frame: 30 Days of Treatment
Saturation of Oxygen in Red Blood Cells (Pulse Ox Measurements; SpO2%)
Time frame: 60 Days of Treatment
Saturation of Oxygen in Red Blood Cells (Pulse Ox Measurements; SpO2%)
Time frame: 90 Days of Treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
- Individual participant dataSharing planned: Yes. YES
Related trials for Body Weight Changes
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Physical Inactivity, Overweight and Obesity
Recruiting
An Online Intuitive Eating Program for Pregnant Women With Obesity to Support Well-Being
Excessive Gestational Weight Gain, Pregnancy
RecruitingPhase 1/2
Phase 1/2 Study of DS010 in Advanced Cancer Patients With Cachexia
Cancer, Cachexia
RecruitingObservational study
Two-Year Weight Loss With GLP-1 Medications Compared With Sleeve Gastrectomy in Adults With Obesity
Obesity & Overweight
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anthropometric Measurement of the Chest, Upper Arm/Bicep, Hips, Thighs and Waist/ Belly in Inches, Oxygen Saturation and Total Blood Chemistry in people with Body Weight Changes, run by Victory Nutrition International, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact DR DEBASIS BAGCHI, PhD (19259486951, debasisbagchi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anthropometric Measurement of the Chest (in Inches) (time frame: 0 Day of Treatment). The study lists 32 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2022.