A Clinical Trial to Assess the Efficacy and Tolerance of a Berberine-based Nutraceutical Formula to Aid Blood Sugar Regulation and Metabolism
NCT ID: NCT06700915
Last Updated: 2024-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2024-10-03
2025-05-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Diaberine
Participants in this arm will receive the Diaberine supplement, which contains Vitamin B12, berberine, magnesium citrate, water-extracted cinnamon bark (Cinnamomum cassia) at a 10:1 ratio, chromium (picolinate), rice flour, dicalcium phosphate, l-leucine, and HPMC (capsule).
Diaberine
Participants will take one capsule three times daily, 15 minutes prior to meals, over a 24-week period.
Placebo
Participants in this arm will receive a placebo capsule containing rice flour, dicalcium phosphate, l-leucine, and HPMC (capsule).
Placebo Capsule
Participants will take one capsule three times daily, 15 minutes prior to meals, over a 24-week period.
Interventions
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Diaberine
Participants will take one capsule three times daily, 15 minutes prior to meals, over a 24-week period.
Placebo Capsule
Participants will take one capsule three times daily, 15 minutes prior to meals, over a 24-week period.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Citruslabs
INDUSTRY
Ultimate International, Inc.
INDUSTRY
Responsible Party
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Locations
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Citruslabs
Santa Monica, California, United States
Countries
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Central Contacts
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Facility Contacts
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Patrick Renner, MSc
Role: primary
Other Identifiers
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20442
Identifier Type: -
Identifier Source: org_study_id