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

3 maart 2022 bijgewerkt door: 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.

Studie Overzicht

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Verwacht)

100

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

    • Pennsylvania
      • Huntingdon Valley, Pennsylvania, Verenigde Staten, 19006
        • Werving
        • Dr Bruce S. Morrison
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

30 jaar tot 70 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

    __________________________________________________________________

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Placebo-vergelijker: 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
Andere namen:
  • Antropometrische metingen
0 - 90 Days of Treatment
0 and 90 Days of Treatment
Adverse Event Monitoring Throughout the Study
0 - 90 Days of Treatment
Andere namen:
  • Adverse Event Monitoring in All Groups
0 - 90 Days of Treatment
Andere namen:
  • Physical well-being
Placebo-vergelijker: 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
Andere namen:
  • Antropometrische metingen
0 - 90 Days of Treatment
0 and 90 Days of Treatment
Adverse Event Monitoring Throughout the Study
0 - 90 Days of Treatment
Andere namen:
  • Adverse Event Monitoring in All Groups
0 - 90 Days of Treatment
Andere namen:
  • Physical well-being
Actieve vergelijker: 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
Andere namen:
  • Antropometrische metingen
0 - 90 Days of Treatment
0 and 90 Days of Treatment
Adverse Event Monitoring Throughout the Study
0 - 90 Days of Treatment
Andere namen:
  • Adverse Event Monitoring in All Groups
0 - 90 Days of Treatment
Andere namen:
  • Physical well-being
Actieve vergelijker: 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
Andere namen:
  • Antropometrische metingen
0 - 90 Days of Treatment
0 and 90 Days of Treatment
Adverse Event Monitoring Throughout the Study
0 - 90 Days of Treatment
Andere namen:
  • Adverse Event Monitoring in All Groups
0 - 90 Days of Treatment
Andere namen:
  • Physical well-being

Wat meet het onderzoek?

Primaire uitkomstmaten

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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Systolic and Diastolic Blood Pressure Measurements (in mmHg)
Tijdsspanne: 0 Day of Treatment
Systolic and Diastolic Blood Pressure Measurements (mmHg)
0 Day of Treatment
Systolic and Diastolic Blood Pressure Measurements (in mmHg)
Tijdsspanne: 30 Days of Treatment
Systolic and Diastolic Blood Pressure Measurements (mmHg)
30 Days of Treatment
Systolic and Diastolic Blood Pressure Measurements (in mmHg)
Tijdsspanne: 60 Days of Treatment
Systolic and Diastolic Blood Pressure Measurements (mmHg)
60 Days of Treatment
Systolic and Diastolic Blood Pressure Measurements (in mmHg)
Tijdsspanne: 90 Days of Treatment
Systolic and Diastolic Blood Pressure Measurements (mmHg)
90 Days of Treatment
Pulse Rate Measurement (in beats per minute; bpm)
Tijdsspanne: 0 Day of Treatment
Pulse Rate (beats per minute; bpm)
0 Day of Treatment
Pulse Rate Measurement (in beats per minute; bpm)
Tijdsspanne: 30 Days of Treatment
Pulse Rate (beats per minute; bpm)
30 Days of Treatment
Pulse Rate Measurement (in beats per minute; bpm)
Tijdsspanne: 60 Days of Treatment
Pulse Rate (beats per minute; bpm)
60 Days of Treatment
Pulse Rate Measurement (in beats per minute; bpm)
Tijdsspanne: 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%)
Tijdsspanne: 0 Day of Treatment
Pulse Ox Measurement (SpO2%)
0 Day of Treatment
Saturation of Oxygen in Red Blood Cells (Pulse Ox Measurements; SpO2%)
Tijdsspanne: 30 Days of Treatment
Pulse Ox Measurement (SpO2%)
30 Days of Treatment
Saturation of Oxygen in Red Blood Cells (Pulse Ox Measurements; SpO2%)
Tijdsspanne: 60 Days of Treatment
Pulse Ox Measurement (SpO2%)
60 Days of Treatment
Saturation of Oxygen in Red Blood Cells (Pulse Ox Measurements; SpO2%)
Tijdsspanne: 90 Days of Treatment
Pulse Ox Measurement (SpO2%)
90 Days of Treatment

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

23 januari 2022

Primaire voltooiing (Verwacht)

28 februari 2023

Studie voltooiing (Verwacht)

9 januari 2024

Studieregistratiedata

Eerst ingediend

10 januari 2022

Eerst ingediend dat voldeed aan de QC-criteria

3 maart 2022

Eerst geplaatst (Werkelijk)

17 maart 2022

Updates van studierecords

Laatste update geplaatst (Werkelijk)

17 maart 2022

Laatste update ingediend die voldeed aan QC-criteria

3 maart 2022

Laatst geverifieerd

1 februari 2022

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

YES

IPD-tijdsbestek voor delen

Jan 23, 2022 to Jan 22, 2023

IPD-toegangscriteria voor delen

www.vni.life

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • MVO

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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