Assessing a berberine-based supplement for blood sugar control
Official title: A Clinical Trial to Assess the Efficacy and Tolerance of a Berberine-based Nutraceutical Formula to Aid Blood Sugar Regulation and Metabolism
Run by Ultimate International, Inc. · NCT06700915 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Ultimate International, Inc. Industry-sponsored |
| Drugs / interventions | bimagrumab, Prednisone |
| Locations | 1 site (Santa Monica, California) |
| Status | Recruiting |
| Started | October 3, 2024 |
| Main results expected | May 1, 2025 |
| Study ends | May 1, 2025 |
| Registry record updated | December 13, 2024 |
| Trial ID | NCT06700915 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are generally healthy adults with a BMI of 27-35 kg/m2 and HbA1c levels between 5.7%-6.4%.
✕Probably not a fit
Patients diagnosed with Type 2 diabetes who are on prescribed medications for blood sugar management will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While the use of berberine for blood sugar regulation has been explored, this specific nutraceutical approach is relatively novel.
Who can join: the full rules
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 it's running
-
Citruslabs
Santa Monica, California, United States Recruiting
Study contacts
- Study coordinator: Patrick Renner, MSc
- Email: hello@citruslabs.com
- Phone: 4242450284
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Transplanting umbilical cord blood from unrelated donors
This study is testing different ways to prepare patients for umbilical cord blood stem cell transplants to see how safe and effective the procedure is for them.
-
Endogenous energy production in critically ill patients
This study tests when critically ill, mechanically ventilated patients start responding normally to feeding by measuring how their own glucose, fat, and protein production changes over time.
-
Investigating the link between biological rhythms and metabolism
This study is trying to see how our body’s natural rhythms affect metabolism and whether this connection can help us understand metabolic disorders better.
-
Amino acid metabolism testing in fed surgical ICU patients
Researchers will use a labeled amino acid injection to test how fed surgical ICU patients process amino acids compared with healthy volunteers.
-
Effects of HIIT vs Strength Training on Health in Postmenopausal Women with Breast Cancer
This study is testing whether high-intensity interval training or strength training can improve heart health and overall well-being in postmenopausal women who have had breast cancer.
-
Heart, kidney, and metabolic health in Shanghai community residents
This follow-up will track people from the STONE cohort to see if changes in metabolic risk factors over time relate to heart and kidney outcomes.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.