A Clinical Trial to Assess the Efficacy and Tolerance of... | NCT06700915

Status Module

Name	Class
Citruslabs	INDUSTRY

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Diaberine	Experimental	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).	Dietary Supplement: Diaberine
Placebo	Placebo Comparator	Participants in this arm will receive a placebo capsule containing rice flour, dicalcium phosphate, l-leucine, and HPMC (capsule).	Dietary Supplement: Placebo Capsule

Name	Type	Description	Arm Group Labels	Other Names
Diaberine	Dietary Supplement	Participants will take one capsule three times daily, 15 minutes prior to meals, over a 24-week period.	Diaberine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood Sugar Regulation	Evaluation of the effect of Diaberine on blood sugar regulation as measured by changes in HbA1c	Baseline, Week 12, and Week 24
Metabolism	Evaluation of the effect of Diaberine on metabolism, as measured by changes in lipid panel levels.	Baseline, Week 12, and Week 24

Secondary Outcomes

Measure	Description	Time Frame
Quality of Life change	Assessment of participant-reported quality of life via a questionnaire.	Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24; Weight: Baseline and Week 24
Weight Change

Eligibility Module

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.