Assessing a berberine-based supplement for blood sugar control
A Clinical Trial to Assess the Efficacy and Tolerance of a Berberine-based Nutraceutical Formula to Aid Blood Sugar Regulation and Metabolism
This study is testing if a new supplement made from berberine can help people control their blood sugar levels better than a placebo.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Ultimate International, Inc. Industry-sponsored |
| Drugs / interventions | bimagrumab, Prednisone |
| Locations | 1 site (Santa Monica, California) |
| Trial ID | NCT06700915 on ClinicalTrials.gov |
What this trial studies
This randomized, triple-blind, placebo-controlled study evaluates the efficacy of Diaberine, a nutraceutical formula based on berberine, in regulating blood sugar and metabolism. The trial will involve 80 participants over a 24-week period, where half will receive the active supplement and the other half a placebo. Participants must maintain their current diet and lifestyle while refraining from other blood sugar-related medications or supplements during the study. The goal is to determine if Diaberine can effectively aid in blood sugar regulation.
Who should consider this trial
Good fit: Ideal candidates are generally healthy adults with a BMI of 27-35 kg/m2 and HbA1c levels between 5.7%-6.4%.
Not a fit: Patients diagnosed with Type 2 diabetes who are on prescribed medications for blood sugar management will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a natural alternative for individuals struggling with blood sugar regulation.
How similar studies have performed: While the use of berberine for blood sugar regulation has been explored, this specific nutraceutical approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female. * BMI: 27-35 kg/m2 * HbA1c of 5.7%-6.4% (determined by prescreening blood test) * Be generally healthy * Willing to refrain from taking any products, prescription medications, or supplements that target blood sugar regulation or metabolism during the test period. * Willing to maintain their current diet, sleep schedule, and activity level for the duration of the study. Exclusion Criteria: * 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. * Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders. * Is currently undergoing or planning to undergo any significant medical procedures in the next six months * Has had any major illness in the last three months. * A history of severe allergic reactions, including but not limited to any of the product's ingredients. * Heavy drinkers or drug users. A heavy drinker is considered to be a woman who drinks 8 or more alcoholic drinks per week or a man who drinks 15 or more alcoholic drinks per week. * Impaired hepatic function. * Individuals taking prescription or over-the-counter medication, or herbal remedies that affect blood sugar regulation or metabolism. * Currently being treated for an infection with an antibiotic and/or antiviral prescription medication.
Where this trial is running
Santa Monica, California
- Citruslabs — Santa Monica, California, United States (Recruiting)
Study contacts
- Study coordinator: Patrick Renner, MSc
- Email: hello@citruslabs.com
- Phone: 4242450284
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.