Efficacy Of Trimrox On Body Recomposition And Weight Management (TRCAP21) (VNI)
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.
研究概览
地位
条件
干预/治疗
- 膳食补充剂:Anthropometric Measurement of the Chest, Upper Arm/Bicep, Hips, Thighs and Waist/ Belly in Inches
- 膳食补充剂:Oxygen Saturation
- 膳食补充剂:Total Blood Chemistry
- 膳食补充剂:Adverse Event Monitoring
- 膳食补充剂:Body Weight Monitoring
- 膳食补充剂:Physical well-being including mood, energy, satiety level. sugar cravings, sleep, and overall health
详细说明
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.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:DR DEBASIS BAGCHI, PhD
- 电话号码:19259486951
- 邮箱:debasisbagchi@gmail.com
学习地点
-
-
Pennsylvania
-
Huntingdon Valley、Pennsylvania、美国、19006
- 招聘中
- Dr Bruce S. Morrison
-
接触:
- Bruce S Morrison, DO
- 电话号码:215-947-9131
- 邮箱:drmorrisonfm@gmail.com
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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.
__________________________________________________________________
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
安慰剂比较: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
|
0 - 90 Days of Treatment
其他名称:
0 - 90 Days of Treatment
0 and 90 Days of Treatment
Adverse Event Monitoring Throughout the Study
0 - 90 Days of Treatment
其他名称:
0 - 90 Days of Treatment
其他名称:
|
安慰剂比较: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
|
0 - 90 Days of Treatment
其他名称:
0 - 90 Days of Treatment
0 and 90 Days of Treatment
Adverse Event Monitoring Throughout the Study
0 - 90 Days of Treatment
其他名称:
0 - 90 Days of Treatment
其他名称:
|
有源比较器: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
|
0 - 90 Days of Treatment
其他名称:
0 - 90 Days of Treatment
0 and 90 Days of Treatment
Adverse Event Monitoring Throughout the Study
0 - 90 Days of Treatment
其他名称:
0 - 90 Days of Treatment
其他名称:
|
有源比较器: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
|
0 - 90 Days of Treatment
其他名称:
0 - 90 Days of Treatment
0 and 90 Days of Treatment
Adverse Event Monitoring Throughout the Study
0 - 90 Days of Treatment
其他名称:
0 - 90 Days of Treatment
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Anthropometric Measurement of the Chest (in Inches)
大体时间:0 Day of Treatment
|
Anthropometric Measurement of the Chest (in Inches)
|
0 Day of Treatment
|
Anthropometric Measurement of the Chest (in Inches)
大体时间:30 Day of Treatment
|
Anthropometric Measurement of the Chest (in Inches)
|
30 Day of Treatment
|
Anthropometric Measurement of the Chest (in Inches)
大体时间:60 Day of Treatment
|
Anthropometric Measurement of the Chest (in Inches)
|
60 Day of Treatment
|
Anthropometric Measurement of the Chest (in Inches)
大体时间:90 Days of Treatment
|
Anthropometric Measurement of the Chest (in Inches)
|
90 Days of Treatment
|
Anthropometric Measurement of the Upper Arm/Bicep (in Inches)
大体时间:0 Day of Treatment
|
Anthropometric Measurement of the Upper Arm/Bicep (in Inches)
|
0 Day of Treatment
|
Anthropometric Measurement of the Upper Arm/Bicep (in Inches)
大体时间:30 Days of Treatment
|
Anthropometric Measurement of the Upper Arm/Bicep (in Inches)
|
30 Days of Treatment
|
Anthropometric Measurement of the Upper Arm/Bicep (in Inches)
大体时间:60 Days of Treatment
|
Anthropometric Measurement of the Upper Arm/Bicep (in Inches)
|
60 Days of Treatment
|
Anthropometric Measurement of the Upper Arm/Bicep (in Inches)
大体时间:90 Days of Treatment
|
Anthropometric Measurement of the Upper Arm/Bicep (in Inches)
|
90 Days of Treatment
|
Anthropometric Measurement of the Hip (in Inches)
大体时间:0 Day of Treatment
|
Anthropometric Measurements of the Hip (in Inches)
|
0 Day of Treatment
|
Anthropometric Measurement of the Hip (in Inches)
大体时间:30 Days of Treatment
|
Anthropometric Measurements of the Hip (in Inches)
|
30 Days of Treatment
|
Anthropometric Measurement of the Hip (in Inches)
大体时间:60 Days of Treatment
|
Anthropometric Measurements of the Hip (in Inches)
|
60 Days of Treatment
|
Anthropometric Measurement of the Hip (in Inches)
大体时间:90 Days of Treatment
|
Anthropometric Measurements of the Hip (in Inches)
|
90 Days of Treatment
|
Anthropometric Measurement of the Thighs (in Inches)
大体时间:0 Day of Treatment
|
Anthropometric Measurement of the Thighs (in Inches)
|
0 Day of Treatment
|
Anthropometric Measurement of the Thighs (in Inches)
大体时间:30 Days of Treatment
|
Anthropometric Measurement of the Thighs (in Inches)
|
30 Days of Treatment
|
Anthropometric Measurement of the Thighs (in Inches)
大体时间:60 Days of Treatment
|
Anthropometric Measurement of the Thighs (in Inches)
|
60 Days of Treatment
|
Anthropometric Measurement of the Thighs (in Inches)
大体时间:90 Days of Treatment
|
Anthropometric Measurement of the Thighs (in Inches)
|
90 Days of Treatment
|
Anthropometric Measurement of the Waist/Belly (in Inches)
大体时间:0 Day of Treatment
|
Anthropometric Measurements of the Waist/Belly (in Inches)
|
0 Day of Treatment
|
Anthropometric Measurement of the Waist/Belly (in Inches)
大体时间:30 Days of Treatment
|
Anthropometric Measurements of the Waist/Belly (in Inches)
|
30 Days of Treatment
|
Anthropometric Measurement of the Waist/Belly (in Inches)
大体时间:60 Days of Treatment
|
Anthropometric Measurements of the Waist/Belly (in Inches)
|
60 Days of Treatment
|
Anthropometric Measurement of the Waist/Belly (in Inches)
大体时间:90 Days of Treatment
|
Anthropometric Measurements of the Waist/Belly (in Inches)
|
90 Days of Treatment
|
Body Weight Measurement (in Kilograms)
大体时间:0 Day of Treatment
|
Body Weight Measurements (in Kilograms)
|
0 Day of Treatment
|
Body Weight Measurement (in Kilograms)
大体时间:30 Days of Treatment
|
Body Weight Measurements (in Kilograms)
|
30 Days of Treatment
|
Body Weight Measurement (in Kilograms)
大体时间:60 Days of Treatment
|
Body Weight Measurements (in Kilograms)
|
60 Days of Treatment
|
Body Weight Measurement (in Kilograms)
大体时间:90 Days of Treatment
|
Body Weight Measurements (in Kilograms)
|
90 Days of Treatment
|
Height Measurement (in Centimeters)
大体时间:0 Day of Treatment
|
Height Measurement (in Centimeters)
|
0 Day of Treatment
|
Height Measurement (in Centimeters)
大体时间:30 Days of Treatment
|
Height Measurement (in Centimeters)
|
30 Days of Treatment
|
Height Measurement (in Centimeters)
大体时间:60 Days of Treatment
|
Height Measurement (in Centimeters)
|
60 Days of Treatment
|
Height Measurement (in Centimeters)
大体时间:90 Days of Treatment
|
Height Measurement (in Centimeters)
|
90 Days of Treatment
|
BMI (body mass index) Measurement (in kg/m^2)
大体时间:0 Day of Treatment
|
BMI (body mass index)(kg/m^2)
|
0 Day of Treatment
|
BMI (body mass index) Measurement (in kg/m^2)
大体时间:30 Days of Treatment
|
BMI (body mass index)(kg/m^2)
|
30 Days of Treatment
|
BMI (body mass index) Measurement (in kg/m^2)
大体时间:60 Days of Treatment
|
BMI (body mass index)(kg/m^2)
|
60 Days of Treatment
|
BMI (body mass index) Measurement (in kg/m^2)
大体时间:90 Days of Treatment
|
BMI (body mass index)(kg/m^2)
|
90 Days of Treatment
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Systolic and Diastolic Blood Pressure Measurements (in mmHg)
大体时间:0 Day of Treatment
|
Systolic and Diastolic Blood Pressure Measurements (mmHg)
|
0 Day of Treatment
|
Systolic and Diastolic Blood Pressure Measurements (in mmHg)
大体时间:30 Days of Treatment
|
Systolic and Diastolic Blood Pressure Measurements (mmHg)
|
30 Days of Treatment
|
Systolic and Diastolic Blood Pressure Measurements (in mmHg)
大体时间:60 Days of Treatment
|
Systolic and Diastolic Blood Pressure Measurements (mmHg)
|
60 Days of Treatment
|
Systolic and Diastolic Blood Pressure Measurements (in mmHg)
大体时间:90 Days of Treatment
|
Systolic and Diastolic Blood Pressure Measurements (mmHg)
|
90 Days of Treatment
|
Pulse Rate Measurement (in beats per minute; bpm)
大体时间:0 Day of Treatment
|
Pulse Rate (beats per minute; bpm)
|
0 Day of Treatment
|
Pulse Rate Measurement (in beats per minute; bpm)
大体时间:30 Days of Treatment
|
Pulse Rate (beats per minute; bpm)
|
30 Days of Treatment
|
Pulse Rate Measurement (in beats per minute; bpm)
大体时间:60 Days of Treatment
|
Pulse Rate (beats per minute; bpm)
|
60 Days of Treatment
|
Pulse Rate Measurement (in beats per minute; bpm)
大体时间:90 Days of Treatment
|
Pulse Rate (beats per minute; bpm)
|
90 Days of Treatment
|
Saturation of Oxygen in Red Blood Cells (Pulse Ox Measurements; SpO2%)
大体时间:0 Day of Treatment
|
Pulse Ox Measurement (SpO2%)
|
0 Day of Treatment
|
Saturation of Oxygen in Red Blood Cells (Pulse Ox Measurements; SpO2%)
大体时间:30 Days of Treatment
|
Pulse Ox Measurement (SpO2%)
|
30 Days of Treatment
|
Saturation of Oxygen in Red Blood Cells (Pulse Ox Measurements; SpO2%)
大体时间:60 Days of Treatment
|
Pulse Ox Measurement (SpO2%)
|
60 Days of Treatment
|
Saturation of Oxygen in Red Blood Cells (Pulse Ox Measurements; SpO2%)
大体时间:90 Days of Treatment
|
Pulse Ox Measurement (SpO2%)
|
90 Days of Treatment
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- VNI-TRIMROX-2022
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
IPD 共享时间框架
IPD 共享访问标准
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
- 分析代码
- 企业社会责任
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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