Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT06700915

A Clinical Trial to Assess the Efficacy and Tolerance of a Berberine-based Nutraceutical Formula to Aid Blood Sugar Regulation and Metabolism

Led by Ultimate International, Inc. · Updated on 2024-12-13

80

Participants Needed

1

Research Sites

30 weeks

Total Duration

On this page

Sponsors

U

Ultimate International, Inc.

Lead Sponsor

C

Citruslabs

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

A Clinical Trial to Assess the Efficacy and Tolerance of a Berberine-based Nutraceutical Formula to Aid Blood Sugar Regulation and Metabolism

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female
  • Body mass index (BMI) between 27 and 35 kg/m2
  • HbA1c level between 5.7% and 6.4% as determined by a prescreening blood test
  • Generally healthy
  • Willing to avoid taking products, prescription medications, or supplements that target blood sugar regulation or metabolism during the study
  • Willing to maintain current diet, sleep schedule, and activity level throughout the study
Not Eligible

You will not qualify if you...

  • Diagnosed with Type 2 diabetes and prescribed specific diabetes medications such as metformin, insulin, or GLP-1 medications
  • Use of certain prescription medications (beta-blockers, thiazide diuretics, corticosteroids, immunosuppressants) within the last 2 months
  • Pregnant, breastfeeding, or trying to conceive
  • Unwilling or unable to follow the study protocol
  • Pre-existing chronic conditions preventing adherence, including cancer and psychiatric disorders
  • Planning or undergoing significant medical procedures in the next six months
  • Major illness within the last three months
  • History of severe allergic reactions to any product ingredients
  • Heavy alcohol use (8+ drinks/week for women, 15+ drinks/week for men) or drug use
  • Impaired liver function
  • Using any medications or herbal remedies that affect blood sugar or metabolism
  • Currently being treated with antibiotics or antiviral medications

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Citruslabs

Santa Monica, California, United States, 90404

Actively Recruiting

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Research Team

P

Patrick Renner, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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