Metabolism DisorderNCT06700915
A Clinical Trial to Assess the Efficacy and Tolerance of a Berberine-based Nutraceutical Formula to Aid Blood Sugar Regulation and Metabolism
A study testing Diaberine in people with Metabolism Disorder and Nutraceutical, run by Ultimate International, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Metabolism Disorder, Nutraceutical
- What is being tested?
- Diaberine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2024to 1 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Citruslabs
Santa Monica, California, 90404
Patrick Renner, MSc, 424-245-0284, hello@citruslabs.com
About this study
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
- Being tested
- Diaberine, Placebo Capsule
- Keywords
- Blood Sugar Regulation, Berberine
- Medical subject headings
- Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiaberineDietary supplement
Participants will take one capsule three times daily, 15 minutes prior to meals, over a 24-week period.
Placebo CapsuleDietary supplement
Participants will take one capsule three times daily, 15 minutes prior to meals, over a 24-week period.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Dietary Supplement: Placebo Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Sugar Regulation
Evaluation of the effect of Diaberine on blood sugar regulation as measured by changes in HbA1c
Measured: Baseline, Week 12, and Week 24
Metabolism
Evaluation of the effect of Diaberine on metabolism, as measured by changes in lipid panel levels.
Measured: Baseline, Week 12, and Week 24
Secondary outcomes (2)
Quality of Life change
Assessment of participant-reported quality of life via a questionnaire.
Measured: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24; Weight: Baseline and Week 24
Weight Change
Evaluation of changes in participant weight.
Measured: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24; Weight: Baseline and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start3 Oct 2024
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolism DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ultimate International, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06700915
- Sponsor's protocol ID
- 20442
- Status last verified
- Dec 2024
- First submitted
- 7 Nov 2024
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Assess the Efficacy and Tolerance of a Berberine-based Nutraceutical Formula to Aid Blood Sugar Regulation and Metabolism
- ClinicalTrials.gov ID
- NCT06700915
- Acronym / sponsor ID
- 20442
- Conditions
- Metabolism Disorder, Nutraceutical
- Keywords
- Blood Sugar Regulation, Berberine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ultimate International, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 3 Oct 2024 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 22 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diaberine | Experimental | Dietary Supplement: DiaberineParticipants 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 | Placebo comparator | Dietary Supplement: Placebo CapsuleParticipants in this arm will receive a placebo capsule containing rice flour, dicalcium phosphate, l-leucine, and HPMC (capsule). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DiaberineParticipants will take one capsule three times daily, 15 minutes prior to meals, over a 24-week period. | Dietary supplement | Diaberine |
| Placebo CapsuleParticipants will take one capsule three times daily, 15 minutes prior to meals, over a 24-week period. | Dietary supplement | Placebo |
Primary outcome
Blood Sugar Regulation
Time frame: Baseline, Week 12, and Week 24
Evaluation of the effect of Diaberine on blood sugar regulation as measured by changes in HbA1c
Metabolism
Time frame: Baseline, Week 12, and Week 24
Evaluation of the effect of Diaberine on metabolism, as measured by changes in lipid panel levels.
2 secondary outcomes
Quality of Life change
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24; Weight: Baseline and Week 24
Weight Change
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24; Weight: Baseline and Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Metabolism Disorder
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diaberine in people with Metabolism Disorder and Nutraceutical, run by Ultimate International, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrick Renner, MSc (4242450284, hello@citruslabs.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Sugar Regulation (time frame: Baseline, Week 12, and Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.