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Recruiting NCT06700915

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

No phase Interventional Metabolism Disorder Nutraceutical

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Diaberine, Placebo Capsule.
Who it may be relevant to
Registry conditions: Metabolism Disorder, Nutraceutical. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Dietary supplement Diaberine
    Participants will take one capsule three times daily, 15 minutes prior to meals, over a 24-week period.
  • Dietary supplement Placebo Capsule
    Participants will take one capsule three times daily, 15 minutes prior to meals, over a 24-week period.

Primary outcome measures

  • Blood Sugar Regulation [Time frame: Baseline, Week 12, and Week 24]
  • Metabolism [Time frame: Baseline, Week 12, and Week 24]
Secondary outcome measures (2)
  • Quality of Life change [Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24; Weight: Baseline and Week 24]
  • Weight Change [Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24; Weight: Baseline and Week 24]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Citruslabs — Santa Monica

Identifiers

NCT: NCT06700915 · 20442

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗