RECRUITING

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

Conditions

Metabolism Disorder Nutraceutical Blood Sugar Regulation Berberine

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-10-03

Study Completion:2025-05-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06700915

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Patrick Renner, MSc

CONTACT

4242450284

hello@citruslabs.com

Study Locations (Sites)

Citruslabs

Santa Monica, California, 90404

United States

Collaborators and Investigators

Sponsor: Ultimate International, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-03

Study Completion Date2025-05-01

Study Record Updates

Study Start Date2024-10-03

Study Completion Date2025-05-01

Terms related to this study

Keywords Provided by Researchers

Blood Sugar Regulation
Berberine

Additional Relevant MeSH Terms

Metabolism Disorder
Nutraceutical