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.
Participants will take one capsule three times daily, 15 minutes prior to meals, over a 24-week period.
Eligibility
Sex: ALLMin age: 18 YearsMax age: 70 Years
Medical Language ↔ Plain English
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.
Locations (1)
Citruslabs
Santa Monica, California, United States
RECRUITING
Outcomes
Primary Outcomes
Blood Sugar Regulation
Evaluation of the effect of Diaberine on blood sugar regulation as measured by changes in HbA1c
Time frame: Baseline, Week 12, and Week 24
Metabolism
Evaluation of the effect of Diaberine on metabolism, as measured by changes in lipid panel levels.
Time frame: Baseline, Week 12, and Week 24
Secondary Outcomes
Quality of Life change
Assessment of participant-reported quality of life via a questionnaire.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24; Weight: Baseline and Week 24
Weight Change
Evaluation of changes in participant weight.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24; Weight: Baseline and Week 24
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NCT06700915 - A Clinical Trial to Assess the Efficacy and Tolerance of a Berberine-based Nutraceutical Formula to Aid Blood Sugar Regulation and Metabolism | Crick | Crick