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_SUPPLEMENT
    Participants will take one capsule three times daily, 15 minutes prior to meals, over a 24-week period.
  • Placebo Capsule — DIETARY_SUPPLEMENT
    Participants 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: Diaberine
    Participants 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: Placebo
    Participants 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

Locations (1)

FacilityCityStateZIPSite coordinators
CitruslabsSanta MonicaCalifornia90404
Patrick Renner, MSc
424-245-0284

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