NCT06700915招募中不适用
A Clinical Trial to Assess the Efficacy and Tolerance of a Berberine-based Nutraceutical Formula to Aid Blood Sugar Regulation and Metabolism
Ultimate International, Inc.2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年10月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Metabolism
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Metabolism
时间窗: Baseline, Week 12, and Week 24
Evaluation of the effect of Diaberine on metabolism, as measured by changes in lipid panel levels.
Blood Sugar Regulation
时间窗: Baseline, Week 12, and Week 24
Evaluation of the effect of Diaberine on blood sugar regulation as measured by changes in HbA1c
次要结局
- 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)
研究者
研究点 (2)
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