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

3. března 2022 aktualizováno: 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.

Přehled studie

Detailní popis

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.

Typ studie

Intervenční

Zápis (Očekávaný)

100

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

    • Pennsylvania
      • Huntingdon Valley, Pennsylvania, Spojené státy, 19006
        • Nábor
        • Dr Bruce S. Morrison
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

30 let až 70 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Všechno

Popis

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.

    __________________________________________________________________

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Podpůrná péče
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Čtyřnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Komparátor placeba: 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
Ostatní jména:
  • Antropometrická měření
0 - 90 Days of Treatment
0 and 90 Days of Treatment
Adverse Event Monitoring Throughout the Study
0 - 90 Days of Treatment
Ostatní jména:
  • Adverse Event Monitoring in All Groups
0 - 90 Days of Treatment
Ostatní jména:
  • Physical well-being
Komparátor placeba: 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
Ostatní jména:
  • Antropometrická měření
0 - 90 Days of Treatment
0 and 90 Days of Treatment
Adverse Event Monitoring Throughout the Study
0 - 90 Days of Treatment
Ostatní jména:
  • Adverse Event Monitoring in All Groups
0 - 90 Days of Treatment
Ostatní jména:
  • Physical well-being
Aktivní komparátor: 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
Ostatní jména:
  • Antropometrická měření
0 - 90 Days of Treatment
0 and 90 Days of Treatment
Adverse Event Monitoring Throughout the Study
0 - 90 Days of Treatment
Ostatní jména:
  • Adverse Event Monitoring in All Groups
0 - 90 Days of Treatment
Ostatní jména:
  • Physical well-being
Aktivní komparátor: 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
Ostatní jména:
  • Antropometrická měření
0 - 90 Days of Treatment
0 and 90 Days of Treatment
Adverse Event Monitoring Throughout the Study
0 - 90 Days of Treatment
Ostatní jména:
  • Adverse Event Monitoring in All Groups
0 - 90 Days of Treatment
Ostatní jména:
  • Physical well-being

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Anthropometric Measurement of the Chest (in Inches)
Časové okno: 0 Day of Treatment
Anthropometric Measurement of the Chest (in Inches)
0 Day of Treatment
Anthropometric Measurement of the Chest (in Inches)
Časové okno: 30 Day of Treatment
Anthropometric Measurement of the Chest (in Inches)
30 Day of Treatment
Anthropometric Measurement of the Chest (in Inches)
Časové okno: 60 Day of Treatment
Anthropometric Measurement of the Chest (in Inches)
60 Day of Treatment
Anthropometric Measurement of the Chest (in Inches)
Časové okno: 90 Days of Treatment
Anthropometric Measurement of the Chest (in Inches)
90 Days of Treatment
Anthropometric Measurement of the Upper Arm/Bicep (in Inches)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 90 Days of Treatment
Anthropometric Measurement of the Upper Arm/Bicep (in Inches)
90 Days of Treatment
Anthropometric Measurement of the Hip (in Inches)
Časové okno: 0 Day of Treatment
Anthropometric Measurements of the Hip (in Inches)
0 Day of Treatment
Anthropometric Measurement of the Hip (in Inches)
Časové okno: 30 Days of Treatment
Anthropometric Measurements of the Hip (in Inches)
30 Days of Treatment
Anthropometric Measurement of the Hip (in Inches)
Časové okno: 60 Days of Treatment
Anthropometric Measurements of the Hip (in Inches)
60 Days of Treatment
Anthropometric Measurement of the Hip (in Inches)
Časové okno: 90 Days of Treatment
Anthropometric Measurements of the Hip (in Inches)
90 Days of Treatment
Anthropometric Measurement of the Thighs (in Inches)
Časové okno: 0 Day of Treatment
Anthropometric Measurement of the Thighs (in Inches)
0 Day of Treatment
Anthropometric Measurement of the Thighs (in Inches)
Časové okno: 30 Days of Treatment
Anthropometric Measurement of the Thighs (in Inches)
30 Days of Treatment
Anthropometric Measurement of the Thighs (in Inches)
Časové okno: 60 Days of Treatment
Anthropometric Measurement of the Thighs (in Inches)
60 Days of Treatment
Anthropometric Measurement of the Thighs (in Inches)
Časové okno: 90 Days of Treatment
Anthropometric Measurement of the Thighs (in Inches)
90 Days of Treatment
Anthropometric Measurement of the Waist/Belly (in Inches)
Časové okno: 0 Day of Treatment
Anthropometric Measurements of the Waist/Belly (in Inches)
0 Day of Treatment
Anthropometric Measurement of the Waist/Belly (in Inches)
Časové okno: 30 Days of Treatment
Anthropometric Measurements of the Waist/Belly (in Inches)
30 Days of Treatment
Anthropometric Measurement of the Waist/Belly (in Inches)
Časové okno: 60 Days of Treatment
Anthropometric Measurements of the Waist/Belly (in Inches)
60 Days of Treatment
Anthropometric Measurement of the Waist/Belly (in Inches)
Časové okno: 90 Days of Treatment
Anthropometric Measurements of the Waist/Belly (in Inches)
90 Days of Treatment
Body Weight Measurement (in Kilograms)
Časové okno: 0 Day of Treatment
Body Weight Measurements (in Kilograms)
0 Day of Treatment
Body Weight Measurement (in Kilograms)
Časové okno: 30 Days of Treatment
Body Weight Measurements (in Kilograms)
30 Days of Treatment
Body Weight Measurement (in Kilograms)
Časové okno: 60 Days of Treatment
Body Weight Measurements (in Kilograms)
60 Days of Treatment
Body Weight Measurement (in Kilograms)
Časové okno: 90 Days of Treatment
Body Weight Measurements (in Kilograms)
90 Days of Treatment
Height Measurement (in Centimeters)
Časové okno: 0 Day of Treatment
Height Measurement (in Centimeters)
0 Day of Treatment
Height Measurement (in Centimeters)
Časové okno: 30 Days of Treatment
Height Measurement (in Centimeters)
30 Days of Treatment
Height Measurement (in Centimeters)
Časové okno: 60 Days of Treatment
Height Measurement (in Centimeters)
60 Days of Treatment
Height Measurement (in Centimeters)
Časové okno: 90 Days of Treatment
Height Measurement (in Centimeters)
90 Days of Treatment
BMI (body mass index) Measurement (in kg/m^2)
Časové okno: 0 Day of Treatment
BMI (body mass index)(kg/m^2)
0 Day of Treatment
BMI (body mass index) Measurement (in kg/m^2)
Časové okno: 30 Days of Treatment
BMI (body mass index)(kg/m^2)
30 Days of Treatment
BMI (body mass index) Measurement (in kg/m^2)
Časové okno: 60 Days of Treatment
BMI (body mass index)(kg/m^2)
60 Days of Treatment
BMI (body mass index) Measurement (in kg/m^2)
Časové okno: 90 Days of Treatment
BMI (body mass index)(kg/m^2)
90 Days of Treatment

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Systolic and Diastolic Blood Pressure Measurements (in mmHg)
Časové okno: 0 Day of Treatment
Systolic and Diastolic Blood Pressure Measurements (mmHg)
0 Day of Treatment
Systolic and Diastolic Blood Pressure Measurements (in mmHg)
Časové okno: 30 Days of Treatment
Systolic and Diastolic Blood Pressure Measurements (mmHg)
30 Days of Treatment
Systolic and Diastolic Blood Pressure Measurements (in mmHg)
Časové okno: 60 Days of Treatment
Systolic and Diastolic Blood Pressure Measurements (mmHg)
60 Days of Treatment
Systolic and Diastolic Blood Pressure Measurements (in mmHg)
Časové okno: 90 Days of Treatment
Systolic and Diastolic Blood Pressure Measurements (mmHg)
90 Days of Treatment
Pulse Rate Measurement (in beats per minute; bpm)
Časové okno: 0 Day of Treatment
Pulse Rate (beats per minute; bpm)
0 Day of Treatment
Pulse Rate Measurement (in beats per minute; bpm)
Časové okno: 30 Days of Treatment
Pulse Rate (beats per minute; bpm)
30 Days of Treatment
Pulse Rate Measurement (in beats per minute; bpm)
Časové okno: 60 Days of Treatment
Pulse Rate (beats per minute; bpm)
60 Days of Treatment
Pulse Rate Measurement (in beats per minute; bpm)
Časové okno: 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%)
Časové okno: 0 Day of Treatment
Pulse Ox Measurement (SpO2%)
0 Day of Treatment
Saturation of Oxygen in Red Blood Cells (Pulse Ox Measurements; SpO2%)
Časové okno: 30 Days of Treatment
Pulse Ox Measurement (SpO2%)
30 Days of Treatment
Saturation of Oxygen in Red Blood Cells (Pulse Ox Measurements; SpO2%)
Časové okno: 60 Days of Treatment
Pulse Ox Measurement (SpO2%)
60 Days of Treatment
Saturation of Oxygen in Red Blood Cells (Pulse Ox Measurements; SpO2%)
Časové okno: 90 Days of Treatment
Pulse Ox Measurement (SpO2%)
90 Days of Treatment

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

23. ledna 2022

Primární dokončení (Očekávaný)

28. února 2023

Dokončení studie (Očekávaný)

9. ledna 2024

Termíny zápisu do studia

První předloženo

10. ledna 2022

První předloženo, které splnilo kritéria kontroly kvality

3. března 2022

První zveřejněno (Aktuální)

17. března 2022

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

17. března 2022

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

3. března 2022

Naposledy ověřeno

1. února 2022

Více informací

Termíny související s touto studií

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

YES

Časový rámec sdílení IPD

Jan 23, 2022 to Jan 22, 2023

Kritéria přístupu pro sdílení IPD

www.vni.life

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • MÍZA
  • ICF
  • ANALYTIC_CODE
  • CSR

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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