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Study of Diaberine for Blood Sugar Regulation and Metabolism

This study is testing a dietary supplement called Diaberine, which contains berberine, to see if it can help regulate blood sugar and improve metabolism. We are looking for 80 adults, aged 18 to 70, who have a body mass index (BMI) between 27 and 35 and an HbA1c (a measure of average blood sugar) between 5.7% and 6.4%. Participants will take either Diaberine or a placebo (an inactive capsule) three times a day before meals for 24 weeks. The main goals are to see how Diaberine affects blood sugar regulation and metabolism over this time. The current recruitment status is unclear.

Study design
This is a randomized, triple-blind, placebo-controlled study involving 80 participants. This means participants will be randomly assigned to receive Diaberine or a placebo, and neither you, your doctors, nor the researchers will know which you are receiving.
What's involved
You would take one capsule three times daily, 15 minutes before meals, for 24 weeks. Your blood sugar regulation and metabolism will be measured at the start, at 12 weeks, and at 24 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your blood sugar and metabolism will be measured at the end of the 24-week treatment period.

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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

Recruiting
NAAges 18–70InterventionalTreatment
Ultimate International, Inc.
~80 participants
Updated 2024-12-13 on ClinicalTrials.gov
What's tested:DiaberinePlacebo Capsule

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Blood Sugar Regulation
Measured over Baseline, Week 12, and Week 24
+1 more outcome measured

Conditions

Metabolism Disorder
Nutraceutical

Explore related trials

Prediabetes

Where it's being run

1 sites across 1 states
California1

Who to contact

Patrick Renner, MSc
[email protected]
4242450284
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Blood Sugar RegulationBaseline, Week 12, and Week 24

    Evaluation of the effect of Diaberine on blood sugar regulation as measured by changes in HbA1c

  • MetabolismBaseline, Week 12, and Week 24

    Evaluation of the effect of Diaberine on metabolism, as measured by changes in lipid panel levels.