Metabolism Disorder, Nutraceutical
Conditions
Keywords
Blood Sugar Regulation, Berberine
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.
Interventions
DIETARY_SUPPLEMENTDiaberine
Participants will take one capsule three times daily, 15 minutes prior to meals, over a 24-week period.
DIETARY_SUPPLEMENTPlacebo Capsule
Participants will take one capsule three times daily, 15 minutes prior to meals, over a 24-week period.
Sponsors
Citruslabs
Ultimate International, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Sugar Regulation | Baseline, Week 12, and Week 24 | Evaluation of the effect of Diaberine on blood sugar regulation as measured by changes in HbA1c |
| Metabolism | Baseline, Week 12, and Week 24 | Evaluation of the effect of Diaberine on metabolism, as measured by changes in lipid panel levels. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life change | Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24; Weight: Baseline and Week 24 | Assessment of participant-reported quality of life via a questionnaire. |
| Weight Change | Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24; Weight: Baseline and Week 24 | Evaluation of changes in participant weight. |
Countries
United States
Contacts
Primary ContactPatrick Renner, MSc
Outcome results
None listed