Recruiting

Berberine

Sponsor:

Ultimate International, Inc.

Code:

NCT06700915

Conditions

Metabolism Disorder

Nutraceutical

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Diaberine

Placebo Capsule

Study Details

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.

Conditions

Metabolism Disorder

Nutraceutical

Study ID

NCT06700915

Start date

Oct 3, 2024

Status verified date

Dec, 2024

Completion date

May 1, 2025

Anticipated

Primary completion date

May 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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).

placebo comparator: Placebo

Participants in this arm will receive a placebo capsule containing rice flour, dicalcium phosphate, l-leucine, and HPMC (capsule).

Interventions

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.

Primary outcome measure

  • Blood Sugar Regulation [ Time Frame: Baseline, Week 12, and Week 24 ]
  • Metabolism [ Time Frame: Baseline, Week 12, and Week 24 ]

Central Contacts and Locations

Central contacts

Patrick Renner, MSc

4242450284hello@citruslabs.com

Locations

Citruslabs

Recruiting

Santa Monica, California, United States, 90404

Contacts

Patrick Renner, MSc

424-245-0284hello@citruslabs.com

More Information

Sponsor

Ultimate International, Inc.

Last update posted

Dec 13, 2024

Last verified

Dec, 2024

Keywords

  • Blood Sugar Regulation
  • Berberine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Ultimate International, Inc. on 2024-12-13.