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

2022년 3월 3일 업데이트: Victory Nutrition International, Inc.

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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (예상)

100

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

    • Pennsylvania
      • Huntingdon Valley, Pennsylvania, 미국, 19006
        • 모병
        • Dr Bruce S. Morrison
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

30년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

설명

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.

    __________________________________________________________________

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
위약 비교기: 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
다른 이름들:
  • 인체 측정
0 - 90 Days of Treatment
0 and 90 Days of Treatment
Adverse Event Monitoring Throughout the Study
0 - 90 Days of Treatment
다른 이름들:
  • Adverse Event Monitoring in All Groups
0 - 90 Days of Treatment
다른 이름들:
  • Physical well-being
위약 비교기: 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
다른 이름들:
  • 인체 측정
0 - 90 Days of Treatment
0 and 90 Days of Treatment
Adverse Event Monitoring Throughout the Study
0 - 90 Days of Treatment
다른 이름들:
  • Adverse Event Monitoring in All Groups
0 - 90 Days of Treatment
다른 이름들:
  • Physical well-being
활성 비교기: 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
다른 이름들:
  • 인체 측정
0 - 90 Days of Treatment
0 and 90 Days of Treatment
Adverse Event Monitoring Throughout the Study
0 - 90 Days of Treatment
다른 이름들:
  • Adverse Event Monitoring in All Groups
0 - 90 Days of Treatment
다른 이름들:
  • Physical well-being
활성 비교기: 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
다른 이름들:
  • 인체 측정
0 - 90 Days of Treatment
0 and 90 Days of Treatment
Adverse Event Monitoring Throughout the Study
0 - 90 Days of Treatment
다른 이름들:
  • Adverse Event Monitoring in All Groups
0 - 90 Days of Treatment
다른 이름들:
  • Physical well-being

연구는 무엇을 측정합니까?

주요 결과 측정

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

2차 결과 측정

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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2022년 1월 23일

기본 완료 (예상)

2023년 2월 28일

연구 완료 (예상)

2024년 1월 9일

연구 등록 날짜

최초 제출

2022년 1월 10일

QC 기준을 충족하는 최초 제출

2022년 3월 3일

처음 게시됨 (실제)

2022년 3월 17일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2022년 3월 17일

QC 기준을 충족하는 마지막 업데이트 제출

2022년 3월 3일

마지막으로 확인됨

2022년 2월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

YES

IPD 공유 기간

Jan 23, 2022 to Jan 22, 2023

IPD 공유 액세스 기준

www.vni.life

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ICF
  • ANALYTIC_CODE
  • CSR

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다