Clinical trial NCT06700915: A Clinical Trial to Assess the Efficacy and Tolerance of a Berberine-based Nutraceutical Formula to Aid Blood Sugar Regulation and Metabolism
Official title: A Clinical Trial to Assess the Efficacy and Tolerance of a Berberine-based Nutraceutical Formula to Aid Blood Sugar Regulation and Metabolism
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metabolism Disorder
Nutraceutical
Keywords: Blood Sugar Regulation
Berberine
Lead sponsor: Ultimate International, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2024-11-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Blood Sugar Regulation
timeFrame: Baseline, Week 12, and Week 24
measure: Metabolism
timeFrame: Baseline, Week 12, and Week 24
Secondary outcomes:
measure: Quality of Life change
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24; Weight: Baseline and Week 24
measure: Weight Change
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24; Weight: Baseline and Week 24
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
References: