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

3 de março de 2022 atualizado por: 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.

Visão geral do estudo

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Antecipado)

100

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

    • Pennsylvania
      • Huntingdon Valley, Pennsylvania, Estados Unidos, 19006
        • Recrutamento
        • Dr Bruce S. Morrison
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

30 anos a 70 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

    __________________________________________________________________

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Cuidados de suporte
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador de Placebo: 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
Outros nomes:
  • Medidas antropométricas
0 - 90 Days of Treatment
0 and 90 Days of Treatment
Adverse Event Monitoring Throughout the Study
0 - 90 Days of Treatment
Outros nomes:
  • Adverse Event Monitoring in All Groups
0 - 90 Days of Treatment
Outros nomes:
  • Physical well-being
Comparador de Placebo: 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
Outros nomes:
  • Medidas antropométricas
0 - 90 Days of Treatment
0 and 90 Days of Treatment
Adverse Event Monitoring Throughout the Study
0 - 90 Days of Treatment
Outros nomes:
  • Adverse Event Monitoring in All Groups
0 - 90 Days of Treatment
Outros nomes:
  • Physical well-being
Comparador Ativo: 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
Outros nomes:
  • Medidas antropométricas
0 - 90 Days of Treatment
0 and 90 Days of Treatment
Adverse Event Monitoring Throughout the Study
0 - 90 Days of Treatment
Outros nomes:
  • Adverse Event Monitoring in All Groups
0 - 90 Days of Treatment
Outros nomes:
  • Physical well-being
Comparador Ativo: 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
Outros nomes:
  • Medidas antropométricas
0 - 90 Days of Treatment
0 and 90 Days of Treatment
Adverse Event Monitoring Throughout the Study
0 - 90 Days of Treatment
Outros nomes:
  • Adverse Event Monitoring in All Groups
0 - 90 Days of Treatment
Outros nomes:
  • Physical well-being

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Anthropometric Measurement of the Chest (in Inches)
Prazo: 0 Day of Treatment
Anthropometric Measurement of the Chest (in Inches)
0 Day of Treatment
Anthropometric Measurement of the Chest (in Inches)
Prazo: 30 Day of Treatment
Anthropometric Measurement of the Chest (in Inches)
30 Day of Treatment
Anthropometric Measurement of the Chest (in Inches)
Prazo: 60 Day of Treatment
Anthropometric Measurement of the Chest (in Inches)
60 Day of Treatment
Anthropometric Measurement of the Chest (in Inches)
Prazo: 90 Days of Treatment
Anthropometric Measurement of the Chest (in Inches)
90 Days of Treatment
Anthropometric Measurement of the Upper Arm/Bicep (in Inches)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 90 Days of Treatment
Anthropometric Measurement of the Upper Arm/Bicep (in Inches)
90 Days of Treatment
Anthropometric Measurement of the Hip (in Inches)
Prazo: 0 Day of Treatment
Anthropometric Measurements of the Hip (in Inches)
0 Day of Treatment
Anthropometric Measurement of the Hip (in Inches)
Prazo: 30 Days of Treatment
Anthropometric Measurements of the Hip (in Inches)
30 Days of Treatment
Anthropometric Measurement of the Hip (in Inches)
Prazo: 60 Days of Treatment
Anthropometric Measurements of the Hip (in Inches)
60 Days of Treatment
Anthropometric Measurement of the Hip (in Inches)
Prazo: 90 Days of Treatment
Anthropometric Measurements of the Hip (in Inches)
90 Days of Treatment
Anthropometric Measurement of the Thighs (in Inches)
Prazo: 0 Day of Treatment
Anthropometric Measurement of the Thighs (in Inches)
0 Day of Treatment
Anthropometric Measurement of the Thighs (in Inches)
Prazo: 30 Days of Treatment
Anthropometric Measurement of the Thighs (in Inches)
30 Days of Treatment
Anthropometric Measurement of the Thighs (in Inches)
Prazo: 60 Days of Treatment
Anthropometric Measurement of the Thighs (in Inches)
60 Days of Treatment
Anthropometric Measurement of the Thighs (in Inches)
Prazo: 90 Days of Treatment
Anthropometric Measurement of the Thighs (in Inches)
90 Days of Treatment
Anthropometric Measurement of the Waist/Belly (in Inches)
Prazo: 0 Day of Treatment
Anthropometric Measurements of the Waist/Belly (in Inches)
0 Day of Treatment
Anthropometric Measurement of the Waist/Belly (in Inches)
Prazo: 30 Days of Treatment
Anthropometric Measurements of the Waist/Belly (in Inches)
30 Days of Treatment
Anthropometric Measurement of the Waist/Belly (in Inches)
Prazo: 60 Days of Treatment
Anthropometric Measurements of the Waist/Belly (in Inches)
60 Days of Treatment
Anthropometric Measurement of the Waist/Belly (in Inches)
Prazo: 90 Days of Treatment
Anthropometric Measurements of the Waist/Belly (in Inches)
90 Days of Treatment
Body Weight Measurement (in Kilograms)
Prazo: 0 Day of Treatment
Body Weight Measurements (in Kilograms)
0 Day of Treatment
Body Weight Measurement (in Kilograms)
Prazo: 30 Days of Treatment
Body Weight Measurements (in Kilograms)
30 Days of Treatment
Body Weight Measurement (in Kilograms)
Prazo: 60 Days of Treatment
Body Weight Measurements (in Kilograms)
60 Days of Treatment
Body Weight Measurement (in Kilograms)
Prazo: 90 Days of Treatment
Body Weight Measurements (in Kilograms)
90 Days of Treatment
Height Measurement (in Centimeters)
Prazo: 0 Day of Treatment
Height Measurement (in Centimeters)
0 Day of Treatment
Height Measurement (in Centimeters)
Prazo: 30 Days of Treatment
Height Measurement (in Centimeters)
30 Days of Treatment
Height Measurement (in Centimeters)
Prazo: 60 Days of Treatment
Height Measurement (in Centimeters)
60 Days of Treatment
Height Measurement (in Centimeters)
Prazo: 90 Days of Treatment
Height Measurement (in Centimeters)
90 Days of Treatment
BMI (body mass index) Measurement (in kg/m^2)
Prazo: 0 Day of Treatment
BMI (body mass index)(kg/m^2)
0 Day of Treatment
BMI (body mass index) Measurement (in kg/m^2)
Prazo: 30 Days of Treatment
BMI (body mass index)(kg/m^2)
30 Days of Treatment
BMI (body mass index) Measurement (in kg/m^2)
Prazo: 60 Days of Treatment
BMI (body mass index)(kg/m^2)
60 Days of Treatment
BMI (body mass index) Measurement (in kg/m^2)
Prazo: 90 Days of Treatment
BMI (body mass index)(kg/m^2)
90 Days of Treatment

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Systolic and Diastolic Blood Pressure Measurements (in mmHg)
Prazo: 0 Day of Treatment
Systolic and Diastolic Blood Pressure Measurements (mmHg)
0 Day of Treatment
Systolic and Diastolic Blood Pressure Measurements (in mmHg)
Prazo: 30 Days of Treatment
Systolic and Diastolic Blood Pressure Measurements (mmHg)
30 Days of Treatment
Systolic and Diastolic Blood Pressure Measurements (in mmHg)
Prazo: 60 Days of Treatment
Systolic and Diastolic Blood Pressure Measurements (mmHg)
60 Days of Treatment
Systolic and Diastolic Blood Pressure Measurements (in mmHg)
Prazo: 90 Days of Treatment
Systolic and Diastolic Blood Pressure Measurements (mmHg)
90 Days of Treatment
Pulse Rate Measurement (in beats per minute; bpm)
Prazo: 0 Day of Treatment
Pulse Rate (beats per minute; bpm)
0 Day of Treatment
Pulse Rate Measurement (in beats per minute; bpm)
Prazo: 30 Days of Treatment
Pulse Rate (beats per minute; bpm)
30 Days of Treatment
Pulse Rate Measurement (in beats per minute; bpm)
Prazo: 60 Days of Treatment
Pulse Rate (beats per minute; bpm)
60 Days of Treatment
Pulse Rate Measurement (in beats per minute; bpm)
Prazo: 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%)
Prazo: 0 Day of Treatment
Pulse Ox Measurement (SpO2%)
0 Day of Treatment
Saturation of Oxygen in Red Blood Cells (Pulse Ox Measurements; SpO2%)
Prazo: 30 Days of Treatment
Pulse Ox Measurement (SpO2%)
30 Days of Treatment
Saturation of Oxygen in Red Blood Cells (Pulse Ox Measurements; SpO2%)
Prazo: 60 Days of Treatment
Pulse Ox Measurement (SpO2%)
60 Days of Treatment
Saturation of Oxygen in Red Blood Cells (Pulse Ox Measurements; SpO2%)
Prazo: 90 Days of Treatment
Pulse Ox Measurement (SpO2%)
90 Days of Treatment

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

23 de janeiro de 2022

Conclusão Primária (Antecipado)

28 de fevereiro de 2023

Conclusão do estudo (Antecipado)

9 de janeiro de 2024

Datas de inscrição no estudo

Enviado pela primeira vez

10 de janeiro de 2022

Enviado pela primeira vez que atendeu aos critérios de CQ

3 de março de 2022

Primeira postagem (Real)

17 de março de 2022

Atualizações de registro de estudo

Última Atualização Postada (Real)

17 de março de 2022

Última atualização enviada que atendeu aos critérios de controle de qualidade

3 de março de 2022

Última verificação

1 de fevereiro de 2022

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

YES

Prazo de Compartilhamento de IPD

Jan 23, 2022 to Jan 22, 2023

Critérios de acesso de compartilhamento IPD

www.vni.life

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA
  • CIF
  • ANALYTIC_CODE
  • CSR

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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