A Clinical Trial to Assess the Efficacy and Tolerance of a Berberine-based Nutraceutical Formula to Aid Blood Sugar Regulation and Metabolism

NCT06700915 | Recruiting

• 1 other identifier: 20442
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

Blood Sugar Regulation; Berberine

Outcome Measures

Primary Outcomes (2)

• 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 (2)

• Quality of Life change

  Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24; Weight: Baseline and Week 24

• Weight Change

  Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24; Weight: Baseline and Week 24

Study Arms (2)

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

Interventions

Diaberine DIETARY_SUPPLEMENT

Participants will take one capsule three times daily, 15 minutes prior to meals, over a 24-week period.

Diaberine

Placebo Capsule DIETARY_SUPPLEMENT

Participants will take one capsule three times daily, 15 minutes prior to meals, over a 24-week period.

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ultimate International, Inc.: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

RECRUITING

MeSH Terms

Conditions

Metabolic Diseases

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Central Study Contacts

Patrick Renner, MSc

CONTACT

4242450284; hello@citruslabs.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: November 22, 2024
• Study Start: October 3, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)