A Clinical Trial to Assess the Efficacy and Tolerance of a Berberine-based Nutraceutical Formula to Aid Blood Sugar Regulation and Metabolism
Part of paid clinical trials in Santa Monica, California.
- Sponsor
- Ultimate International, Inc.
- Study ID
- NCT06700915
- Status
- Recruiting
Conditions
- Metabolism Disorder
- Nutraceutical
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- Diaberine — DIETARY_SUPPLEMENTParticipants will take one capsule three times daily, 15 minutes prior to meals, over a 24-week period.
- Placebo Capsule — DIETARY_SUPPLEMENTParticipants will take one capsule three times daily, 15 minutes prior to meals, over a 24-week period.
Study Details
This randomized, triple-blind, placebo-controlled study will evaluate the efficacy of Diaberine, a berberine-based nutraceutical, in aiding blood sugar regulation and metabolism in 80 participants over 24 weeks.
Key Dates
- Start date
- Oct 3, 2024
- Status verified
- Dec 2024
- Primary completion
- May 1, 2025
- Completion
- May 1, 2025
Study Design
- Enrollment
- 80 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: DiaberineParticipants in this arm will receive the Diaberine supplement, which contains Vitamin B12, berberine, magnesium citrate, water-extracted cinnamon bark (Cinnamomum cassia) at a 10:1 ratio, chromium (picolinate), rice flour, dicalcium phosphate, l-leucine, and HPMC (capsule).
- Placebo Comparator: PlaceboParticipants in this arm will receive a placebo capsule containing rice flour, dicalcium phosphate, l-leucine, and HPMC (capsule).
Primary Outcome Measure
Blood Sugar Regulation [ Time Frame: Baseline, Week 12, and Week 24 ]
Central Contacts
- Patrick Renner, MSc4242450284
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Citruslabs | Santa Monica | California | 90404 |
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