Efficacy Of Trimrox On Body Recomposition And Weight Management (TRCAP21)
NCT05283525 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2022-03-17
Summary
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.
Conditions
- Body Weight Changes
Interventions
- DIETARY_SUPPLEMENT
-
Anthropometric Measurement of the Chest, Upper Arm/Bicep, Hips, Thighs and Waist/ Belly in Inches
0 - 90 Days of Treatment
- DIETARY_SUPPLEMENT
-
Oxygen Saturation
0 - 90 Days of Treatment
- DIETARY_SUPPLEMENT
-
Total Blood Chemistry
0 and 90 Days of Treatment
- DIETARY_SUPPLEMENT
-
Adverse Event Monitoring
Adverse Event Monitoring Throughout the Study
- DIETARY_SUPPLEMENT
-
Body Weight Monitoring
0 - 90 Days of Treatment
- DIETARY_SUPPLEMENT
-
Physical well-being including mood, energy, satiety level. sugar cravings, sleep, and overall health
0 - 90 Days of Treatment
Sponsors & Collaborators
-
Victory Nutrition International, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 30 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-01-23
- Primary Completion
- 2023-02-28
- Completion
- 2024-01-09
Countries
- United States
Study Locations
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