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

2022年3月3日 更新者: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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (予想される)

100

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

    • Pennsylvania
      • Huntingdon Valley、Pennsylvania、アメリカ、19006
        • 募集
        • Dr Bruce S. Morrison
        • コンタクト:

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

30年~70年 (大人、高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

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.

    __________________________________________________________________

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:支持療法
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:4倍

武器と介入

参加者グループ / アーム
介入・治療
プラセボコンパレーター: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
他の名前:
  • 人体測定
0 - 90 Days of Treatment
0 and 90 Days of Treatment
Adverse Event Monitoring Throughout the Study
0 - 90 Days of Treatment
他の名前:
  • Adverse Event Monitoring in All Groups
0 - 90 Days of Treatment
他の名前:
  • Physical well-being
プラセボコンパレーター: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
他の名前:
  • 人体測定
0 - 90 Days of Treatment
0 and 90 Days of Treatment
Adverse Event Monitoring Throughout the Study
0 - 90 Days of Treatment
他の名前:
  • Adverse Event Monitoring in All Groups
0 - 90 Days of Treatment
他の名前:
  • Physical well-being
アクティブコンパレータ: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
他の名前:
  • 人体測定
0 - 90 Days of Treatment
0 and 90 Days of Treatment
Adverse Event Monitoring Throughout the Study
0 - 90 Days of Treatment
他の名前:
  • Adverse Event Monitoring in All Groups
0 - 90 Days of Treatment
他の名前:
  • Physical well-being
アクティブコンパレータ: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
他の名前:
  • 人体測定
0 - 90 Days of Treatment
0 and 90 Days of Treatment
Adverse Event Monitoring Throughout the Study
0 - 90 Days of Treatment
他の名前:
  • Adverse Event Monitoring in All Groups
0 - 90 Days of Treatment
他の名前:
  • Physical well-being

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Anthropometric Measurement of the Chest (in Inches)
時間枠:0 Day of Treatment
Anthropometric Measurement of the Chest (in Inches)
0 Day of Treatment
Anthropometric Measurement of the Chest (in Inches)
時間枠:30 Day of Treatment
Anthropometric Measurement of the Chest (in Inches)
30 Day of Treatment
Anthropometric Measurement of the Chest (in Inches)
時間枠:60 Day of Treatment
Anthropometric Measurement of the Chest (in Inches)
60 Day of Treatment
Anthropometric Measurement of the Chest (in Inches)
時間枠:90 Days of Treatment
Anthropometric Measurement of the Chest (in Inches)
90 Days of Treatment
Anthropometric Measurement of the Upper Arm/Bicep (in Inches)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠:90 Days of Treatment
Anthropometric Measurement of the Upper Arm/Bicep (in Inches)
90 Days of Treatment
Anthropometric Measurement of the Hip (in Inches)
時間枠:0 Day of Treatment
Anthropometric Measurements of the Hip (in Inches)
0 Day of Treatment
Anthropometric Measurement of the Hip (in Inches)
時間枠:30 Days of Treatment
Anthropometric Measurements of the Hip (in Inches)
30 Days of Treatment
Anthropometric Measurement of the Hip (in Inches)
時間枠:60 Days of Treatment
Anthropometric Measurements of the Hip (in Inches)
60 Days of Treatment
Anthropometric Measurement of the Hip (in Inches)
時間枠:90 Days of Treatment
Anthropometric Measurements of the Hip (in Inches)
90 Days of Treatment
Anthropometric Measurement of the Thighs (in Inches)
時間枠:0 Day of Treatment
Anthropometric Measurement of the Thighs (in Inches)
0 Day of Treatment
Anthropometric Measurement of the Thighs (in Inches)
時間枠:30 Days of Treatment
Anthropometric Measurement of the Thighs (in Inches)
30 Days of Treatment
Anthropometric Measurement of the Thighs (in Inches)
時間枠:60 Days of Treatment
Anthropometric Measurement of the Thighs (in Inches)
60 Days of Treatment
Anthropometric Measurement of the Thighs (in Inches)
時間枠:90 Days of Treatment
Anthropometric Measurement of the Thighs (in Inches)
90 Days of Treatment
Anthropometric Measurement of the Waist/Belly (in Inches)
時間枠:0 Day of Treatment
Anthropometric Measurements of the Waist/Belly (in Inches)
0 Day of Treatment
Anthropometric Measurement of the Waist/Belly (in Inches)
時間枠:30 Days of Treatment
Anthropometric Measurements of the Waist/Belly (in Inches)
30 Days of Treatment
Anthropometric Measurement of the Waist/Belly (in Inches)
時間枠:60 Days of Treatment
Anthropometric Measurements of the Waist/Belly (in Inches)
60 Days of Treatment
Anthropometric Measurement of the Waist/Belly (in Inches)
時間枠:90 Days of Treatment
Anthropometric Measurements of the Waist/Belly (in Inches)
90 Days of Treatment
Body Weight Measurement (in Kilograms)
時間枠:0 Day of Treatment
Body Weight Measurements (in Kilograms)
0 Day of Treatment
Body Weight Measurement (in Kilograms)
時間枠:30 Days of Treatment
Body Weight Measurements (in Kilograms)
30 Days of Treatment
Body Weight Measurement (in Kilograms)
時間枠:60 Days of Treatment
Body Weight Measurements (in Kilograms)
60 Days of Treatment
Body Weight Measurement (in Kilograms)
時間枠:90 Days of Treatment
Body Weight Measurements (in Kilograms)
90 Days of Treatment
Height Measurement (in Centimeters)
時間枠:0 Day of Treatment
Height Measurement (in Centimeters)
0 Day of Treatment
Height Measurement (in Centimeters)
時間枠:30 Days of Treatment
Height Measurement (in Centimeters)
30 Days of Treatment
Height Measurement (in Centimeters)
時間枠:60 Days of Treatment
Height Measurement (in Centimeters)
60 Days of Treatment
Height Measurement (in Centimeters)
時間枠:90 Days of Treatment
Height Measurement (in Centimeters)
90 Days of Treatment
BMI (body mass index) Measurement (in kg/m^2)
時間枠:0 Day of Treatment
BMI (body mass index)(kg/m^2)
0 Day of Treatment
BMI (body mass index) Measurement (in kg/m^2)
時間枠:30 Days of Treatment
BMI (body mass index)(kg/m^2)
30 Days of Treatment
BMI (body mass index) Measurement (in kg/m^2)
時間枠:60 Days of Treatment
BMI (body mass index)(kg/m^2)
60 Days of Treatment
BMI (body mass index) Measurement (in kg/m^2)
時間枠:90 Days of Treatment
BMI (body mass index)(kg/m^2)
90 Days of Treatment

二次結果の測定

結果測定
メジャーの説明
時間枠
Systolic and Diastolic Blood Pressure Measurements (in mmHg)
時間枠:0 Day of Treatment
Systolic and Diastolic Blood Pressure Measurements (mmHg)
0 Day of Treatment
Systolic and Diastolic Blood Pressure Measurements (in mmHg)
時間枠:30 Days of Treatment
Systolic and Diastolic Blood Pressure Measurements (mmHg)
30 Days of Treatment
Systolic and Diastolic Blood Pressure Measurements (in mmHg)
時間枠:60 Days of Treatment
Systolic and Diastolic Blood Pressure Measurements (mmHg)
60 Days of Treatment
Systolic and Diastolic Blood Pressure Measurements (in mmHg)
時間枠:90 Days of Treatment
Systolic and Diastolic Blood Pressure Measurements (mmHg)
90 Days of Treatment
Pulse Rate Measurement (in beats per minute; bpm)
時間枠:0 Day of Treatment
Pulse Rate (beats per minute; bpm)
0 Day of Treatment
Pulse Rate Measurement (in beats per minute; bpm)
時間枠:30 Days of Treatment
Pulse Rate (beats per minute; bpm)
30 Days of Treatment
Pulse Rate Measurement (in beats per minute; bpm)
時間枠:60 Days of Treatment
Pulse Rate (beats per minute; bpm)
60 Days of Treatment
Pulse Rate Measurement (in beats per minute; bpm)
時間枠: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%)
時間枠:0 Day of Treatment
Pulse Ox Measurement (SpO2%)
0 Day of Treatment
Saturation of Oxygen in Red Blood Cells (Pulse Ox Measurements; SpO2%)
時間枠:30 Days of Treatment
Pulse Ox Measurement (SpO2%)
30 Days of Treatment
Saturation of Oxygen in Red Blood Cells (Pulse Ox Measurements; SpO2%)
時間枠:60 Days of Treatment
Pulse Ox Measurement (SpO2%)
60 Days of Treatment
Saturation of Oxygen in Red Blood Cells (Pulse Ox Measurements; SpO2%)
時間枠:90 Days of Treatment
Pulse Ox Measurement (SpO2%)
90 Days of Treatment

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2022年1月23日

一次修了 (予想される)

2023年2月28日

研究の完了 (予想される)

2024年1月9日

試験登録日

最初に提出

2022年1月10日

QC基準を満たした最初の提出物

2022年3月3日

最初の投稿 (実際)

2022年3月17日

学習記録の更新

投稿された最後の更新 (実際)

2022年3月17日

QC基準を満たした最後の更新が送信されました

2022年3月3日

最終確認日

2022年2月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

YES

IPD 共有時間枠

Jan 23, 2022 to Jan 22, 2023

IPD 共有アクセス基準

www.vni.life

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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