Efficacy Of Trimrox On Body Recomposition And Weight Management (TRCAP21)
Status unconfirmed · Not applicable · Has a placebo group
Conditions studied: Body Weight Changes
In brief
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.
Key facts
- Study ID
- NCT05283525
- Run by
- Victory Nutrition International, Inc.
- People needed
- 100
- Starts
- 2022-01-23
- Expected to finish
- 2024-01-09
- Last updated by the study team
- 2022-03-17
Who can join
Age: 30 and older, up to 70. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Agrees to sign written and audio-visual informed consent.
- Fully understand the risks and benefits of the study
- Male and Female Subjects (age: 30-70 Y)
- Subjects are deemed to be acceptable for this study by their physician
You may not qualify if…
- Subjects who are unwilling or uncooperative subjects
- Subjects were excluded who had impaired hepatic functions i,e., SGOT/SGPT >2.5 X
- Subjects suffering from type 1 diabetes
- Subjects suffering from type 2 diabetes or anyone else that has a blood glucose levels >180 mg/dl or HbA1c > 8.
- Subjects who were suffering from coronary artery disease or high blood pressure >180/100
- 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
- Subjects who have cancer and are suffering from a malignancy.
- Hypersensitivity to the investigational supplement
- Subjects who had used any known weight management supplement for the last 2 months.
- History of blood coagulation and bleeding (coagulopathies)
- Incidence of high alcohol intake (more than 2 standard drinks/day).
- Psychiatric disorder/disability provide signed informed consent.
- Existing medical condition of the participant, which may be detrimental to the study and subject's overall well-being.
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Where it is running
- Dr Bruce S. Morrison — Huntingdon Valley, Pennsylvania, United States (enrolling)
Full record on ClinicalTrials.gov
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