Randomized Controlled Trial of Almond Supplementation vs. Isocaloric Diet on Cognitive Functions in Middle-aged (40-60 Years) Asian Indians With Prediabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- neuropsychological function
研究概览
简要总结
Initial Recruitment and Sensitization: In this free-living randomized control parallel arm study of 24 weeks of almond intervention, we shall recruit apparently healthy middle aged (age range 40-60 years)prediabetic Asian Indians having fasting blood glucose ≥100mg/dl and <126 mg/dl and /or 2-h plasma glucose ≥140mg/dl and <200mg/dl (after ingestion of 75-gram anhydrous oral glucose).
详细描述
Objectives and Measurements:
a. Primary Objective: To evaluate the effect of almond supplementation on cognitive functions Co-primary Objective: To evaluate changes in neuroimaging (blood flow, and the expression of functional brain networks during cognitive demands) using functional MRI.
Flow of Study Procedures
- This will be a randomized controlled parallel arm study on free living Asian Indians, selected based on inclusion criteria.
- Sample size: 60 (n, 30 in each arm)
- After recruitment subjects would enter the run-in period for 2 weeks when they would be given standard diet and lifestyle modification counseling formulated according to guidelines for Asian Indians.
- Subjects would be screened again just for inclusion/exclusion criteria at the end of the run-in period and would be randomized either to the experimental group or control group
- Composition of diets:
i. Intervention group: Individualized diets incorporating almonds, 20% energy. Macronutrient composition: Carbohydrates,49%en., fats,32%en., and proteins, 19%en.
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
- None
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Asian Indians having fasting blood glucose ≥100mg/dl and <126 mg/dl and /or 2-h plasma glucose ≥140mg/dl and <200mg/dl (after ingestion of 75-gram anhydrous oral glucose)
- •age 40-60 years
排除标准
- •Subjects Having Inability to Undergo Neuropsychological Testing
- •Previously Diagnosed Neurodegenerative Disease Prior Stroke
- •Significant Head Trauma, or Brain Surgery
- •Relevant Psychiatric Illness
- •Major Depression
- •Morbid Obesity
- •Uncontrolled Hypertension
- •Prior Chemotherapy
- •Allergy to Almonds
- •Habitual Consumption of Tree nuts (>2 Servings/Wk.); or Customary Use Of Fish Oil, Flaxseed Oil, and/ Or Soy Lecithin
- •Chronic Smoking
- •Alcohol abuse (> 2 Drinks, 60 Ml Of Whisky Per Day)
- •Severe Dyslipidemia (Total Cholesterol > 300 Mg/Dl, Serum Triglycerides > 500mg/Dl)
研究组 & 干预措施
Control
usual diet and lifestyle
almond
dietary intervention with almonds ()20% of energy)
干预措施: Almond (Dietary Supplement)
结局指标
主要结局
neuropsychological function
时间窗: 2 year
cognitive functions using computerized neuropsychological assessment systems (CANTAB
次要结局
未报告次要终点