Recruiting

Berberine-based Nutraceutical for Blood Sugar and Metabolism

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What is being tested

Diaberine

+ Placebo Capsule

Dietary Supplement
Who is being recruted

Metabolic Diseases

+ Nutritional and Metabolic Diseases

From 18 to 70 Years
+18 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: October 2024
See protocol details

Summary

Principal SponsorUltimate International, Inc.
Study ContactPatrick Renner, MSc
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 3, 2024

Actual date on which the first participant was enrolled.

This study is designed to test how well a supplement called Diaberine, which contains berberine, helps control blood sugar levels and improve metabolism. It involves 80 individuals who will participate over a period of 24 weeks. The study aims to provide insights into how effective and tolerable this supplement is for managing blood sugar, which could benefit those dealing with related health issues. This research is important as it explores potential new ways to support people with blood sugar regulation challenges. Participants in the study will be randomly assigned to either receive the Diaberine supplement or a placebo, which is a harmless pill that does not contain the active ingredient. The study is triple-blind, meaning that neither the participants, the researchers, nor the data analysts will know who is receiving the actual supplement and who is receiving the placebo. This approach helps ensure unbiased results. Throughout the 24 weeks, various measures will be taken to assess how well the supplement is working and whether it is well-tolerated by the participants.

Official TitleA Clinical Trial to Assess the Efficacy and Tolerance of a Berberine-based Nutraceutical Formula to Aid Blood Sugar Regulation and Metabolism
Principal SponsorUltimate International, Inc.
Study ContactPatrick Renner, MSc
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

80 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Metabolic DiseasesNutritional and Metabolic Diseases

Criteria

6 inclusion criteria required to participate
Male or female.

BMI: 27-35 kg/m2

HbA1c of 5.7%-6.4% (determined by prescreening blood test)

Be generally healthy

Show More Criteria

12 exclusion criteria prevent from participating
Diagnosed with Type 2 diabetes mellitus (T2DM) and have been prescribed metformin, insulin, Sulfonylureas, Meglitinides, SGLT2 inhibitors and/or GLP-1 medications including the following prescription medications: Wegovy (semaglutide), Ozempic (semaglutide), Rybelsus (semaglutide), Saxenda (liraglutide), Victoza (liraglutide), Zepbound (bimagrumab), Byetta (exenatide), Bydureon (exenatide ER), Trulicity (dulaglutide), Adlyxin (lixisenatide)

Current use or past history of use within the last 2 months (8 weeks) of the following prescription medications: Beta-blockers Sectral (Acebutolol), Tenormin (Atenolol), Kerlone, Betoptic (Betaxolol), Zebeta (Bisoprolol), Coreg, Coreg CR (Carvedilol), Trandate, Normodyne (Labetalol), Lopressor, Toprol XL (Metoprolol), Corgard (Nadolol), Bystolic (Nebivolol), Levatol (Penbutolol), Visken (Pindolol), Inderal, Inderal LA, InnoPran XL (Propranolol). Thiazide diuretics Diuril (Chlorothiazide), Microzide (Hydrochlorothiazide), Thalitone, Hygroton (Chlorthalidone), Lozol (Indapamide), Zaroxolyn (Metolazone), Naturetin (Bendroflumethiazide), Enduron (Methyclothiazide). Corticosteroids Deltasone (Prednisone), Orapred, Prelone (Prednisolone), Medrol (Methylprednisolone), Qvar (Beclomethasone), Celestone (Betamethasone), Decadron (Dexamethasone), Cortef (Hydrocortisone), Kenalog (Triamcinolone). Immunosuppressants Tacrolimus (Prograf), Cyclosporine (Neoral), Sirolimus (Rapamune)

Women who are pregnant, breastfeeding, or trying to conceive.

Anyone unwilling or unable to follow the study protocol.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
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).

Group II

Placebo
Participants in this arm will receive a placebo capsule containing rice flour, dicalcium phosphate, l-leucine, and HPMC (capsule).

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Citruslabs

Santa Monica, United StatesOpen Citruslabs in Google Maps
Recruiting
One Study Center
Berberine-based Nutraceutical for Blood Sugar and Metabolism | PatLynk