NCT06417840招募中不适用
To Evaluate the Impact of Consumption of a Bioactive Compound Extracted From Fermented Yeast on Fasting Blood Glucose Levels in Asian Indians With Pre-diabetes: A Randomized, Double Blinded, Placebo-controlled Parallel Arm Trial
Brightseed1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2024年6月22日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Fasting Blood Glucose
研究概览
简要总结
This is randomized placebo controlled, double-blinded, parallel arm study on free living Asian Indians. Eligible subjects will undergo one-week run-in period and subjects will be asked to maintain their usual diet and exercise regime. At the end of the run-in period, subjects fulfilling the inclusion/exclusion criteria at this stage will be randomized either to the intervention arm or control arm using computerized random number tables.
The measured parameters will include, 24-h diet recall, food frequency questionnaire, anthropometry including circumferences, height and weight, and blood parameters including blood glucose (fasting), serum insulin (fasting), HbA1c and lipid profile.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fasting Blood Glucose between 100-125 mg/dL;
- •and BMI range 25-30 kg/m2;
- •and waist circumference ≥80cm for women and ≥90cm for men;
排除标准
- •Weight loss or gain ≥4.5 kg within 90 days of visit
- •Use of weight loss medications within 90 days of visit
- •History of gastrointestinal surgery (e.g., bariatric surgery) or cosmetic procedures (e.g., liposuction) for weight/fat reducing purposes.
- •Use of dietary supplements or related products that, in the judgment of the Investigator, are likely to markedly affect weight loss or appetite within 30 days of visit
- •History of extreme dietary habits (e.g., Atkins diet, etc.), as judged by the Investigator.
- •History of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional.
- •Current medical diagnosis of type 1 or type 2 diabetes mellitus.
- •HbA1c ≥48 mmol/mol (6.5%) as measured at visit
- •History of a chronic gastrointestinal disorder, such as peptic ulcer disease or malabsorption syndrome (mild lactose intolerance or gastroesophageal reflux diseases are acceptable).
- •Signs or symptoms of an active infection of clinical relevance within 5 days of visit
- •The visit may be rescheduled such that all signs and symptoms have resolved (at the discretion of the Clinical Investigator) at least 5 days prior to visit
- •Is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period. The method of contraception must be recorded in the source document.
- •Any condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, or which might confound the interpretation of the study results or put the person at undue risk.
- •Excessive alcohol consumption (> 2 Drinks, 60 ml of Whisky Per Day).
研究组 & 干预措施
Placebo Control
Placebo Comparator
干预措施: Placebo Control (Dietary Supplement)
N-trans-caffeoyltyramine (NCT) and N-trans-feruloyltyramine (NFT)
Experimental
干预措施: N-trans-caffeoyltyramine (NCT) and N-trans-feruloyltyramine (NFT) (Dietary Supplement)
结局指标
主要结局
Fasting Blood Glucose
时间窗: 0, and 28 days
Blood Glucose Concentration mg/dL
次要结局
- Fasting Blood Insulin(0, and 28 days)
- Height(0, and 28 days)
- Continuous Glucose Monitoring(0, and 28 days)
- HbA1c(0, and 28 days)
- Waist Circumference(0, and 28 days)
- Total Cholesterol(0, and 28 days)
- Low-density lipoprotein (LDL) cholesterol(0, and 28 days)
- High-density lipoprotein (HDL) cholesterol(0, and 28 days)
- Triglycerides(0, and 28 days)
- Weight(0, and 28 days)
- Body Mass Index (BMI)(0, and 28 days)
研究者
研究点 (1)
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