Actively Recruiting
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
N/A
Total Duration
On this page
Sponsors
U
Ultimate International, Inc.
Lead Sponsor
C
Citruslabs
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of Diaberine, a berberine-based nutraceutical, on blood sugar regulation and metabolism in adults with metabolism disorder. This randomized, triple-blind, placebo-controlled trial will study 80 participants aged 18 to 70 over 24 weeks to assess how well this dietary supplement may aid in these health areas. Participants will be randomly assigned to one of two groups. One group will take Diaberine capsules containing Vitamin B12, berberine, magnesium citrate, cinnamon bark extract, chromium, and other ingredients three times daily, 15 minutes before meals. The other group will take placebo capsules with similar appearance but without the active ingredients. Both treatments will continue for 24 weeks with regular monitoring. During the study, participants will have their blood sugar regulation and metabolism measured at baseline, week 12, and week 24. Additionally, quality of life and weight changes will be tracked at multiple points throughout the 24 weeks. Participants will be monitored through questionnaires, blood tests, and weight assessments to evaluate the supplement's effects and tolerance over time.
CONDITIONS
Brief 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
Eligibility Criteria
You may qualify if you...
- Male or female.
- Body mass index (BMI) between 27 and 35 kg/m2.
- HbA1c levels between 5.7% and 6.4% as determined by prescreening blood test.
- Be generally healthy.
- Willing to avoid taking any 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 during the study.
You will not qualify if you...
- Diagnosed with Type 2 diabetes and prescribed medications such as metformin, insulin, or similar drugs.
- Use or history within 8 weeks of certain prescription medications including beta-blockers, thiazide diuretics, corticosteroids, or immunosuppressants.
- Women who are pregnant, breastfeeding, or trying to conceive.
- Unwilling or unable to follow the study protocol.
- Pre-existing chronic conditions including cancer or psychiatric disorders that prevent adherence.
- Planning significant medical procedures within 6 months.
- Major illness in the last 3 months.
- History of severe allergic reactions to product ingredients.
- Heavy alcohol or drug use.
- Impaired liver function.
- Taking medications or herbal remedies affecting blood sugar or metabolism.
- Currently treated for infection with antibiotics or antiviral medications.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants take one capsule three times daily, 15 minutes prior to meals, for 24 weeks to assess the efficacy and tolerance of the berberine-based nutraceutical formula.
Visits at Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Trial Site Locations
Total: 1 location
1
Citruslabs
Santa Monica, California, United States, 90404
Actively Recruiting
Research Team
P
Patrick Renner, MSc
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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