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

Not Applicable

Recruiting

• Conditions: Metabolism Disorder; Nutraceutical

• Registration Number: NCT06700915
• Lead Sponsor: Ultimate International, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-10-03
• Study First Submitted: 2024-11-07
• Study First Submitted QC: 2024-11-19
• Study First Posted: 2024-11-22
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-13
• Primary Completion: 2025-05-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Blood Sugar Regulation	Baseline, Week 12, and Week 24	Evaluation of the effect of Diaberine on blood sugar regulation as measured by changes in HbA1c
Metabolism	Baseline, Week 12, and Week 24	Evaluation of the effect of Diaberine on metabolism, as measured by changes in lipid panel levels.

Secondary Outcome Measures

Name	Time	Method
Quality of Life change	Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24; Weight: Baseline and Week 24	Assessment of participant-reported quality of life via a questionnaire.
Weight Change	Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24; Weight: Baseline and Week 24	Evaluation of changes in participant weight.

Trial Locations

Locations (1)

Citruslabs; 🇺🇸 Santa Monica, California, United States