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Tests treatment safety and results for Metabolism Disorder
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
What this study is testing
- What it's testing
- 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.
- Time commitment: about 24 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join 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...
You likely can't join if
- Diagnosed with Type 2 diabetes mellitus (T2DM) and have been prescribed metformin, insulin, Sulfonylureas, Meglitinides, SGLT2 inhibitors and/or...
- Current use or past history of use within the last 2 months (8 weeks) of the following prescription medications: Beta-blockers Sectral (Acebutolol)...
- 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
See the full eligibility 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Santa Monica, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Santa Monica, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.