Effects of Peanut Consumption on Cardiovascular Disease Risk Factors and Gut Microbiota Among Adults in China: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 238
- 试验地点
- 1
- 主要终点
- Blood glucose
研究概览
简要总结
This is a 2 parallel-arm randomized controlled study with free-living subjects on self-selected diets. The objective of this study is to compare the effects of two servings of peanuts with an isocaloric matched refined carbohydrate snack food on glucose, lipids and lipoproteins and cardiovascular health risk factors, satiety and gut microbiota in 250 Chinese participants at risk for metabolic syndrome (overweight/obese, enlarged waist circumference, elevated LDL-cholesterol, prehypertension, and/or prediabetes).
The investigators hypothesize that the inclusion of 2 serving of peanuts in the diet will decrease blood glucose, LDL-cholesterol, and improve satiety sanctification between meals and gut microbiota compared to the control group and baseline.
详细描述
Emerging evidence has shown that peanut consumption has beneficial effects in modifying lipid profiles, glucose, and other cardiometabolic risk factors. During the last two decades, China has experienced a dramatic increase in T2D prevalence largely due to rapid social and economic growth. Peanuts are commonly consumed as snacks in China. However, there is limited evidence on the specific health benefits of peanuts as part of the Chinese habitual diet.
Clinical Study Protocol
Study diet Subjects will consume their habitual diet with the test snacks provided as roasted peanuts and rice flour snack bars twice a day during a mid- morning snack and mid -afternoon snack. Subjects in the peanut group will consume two serving of peanuts and subjects in the control group will consume isocaloric rice bars on a daily basis under on site supervision. Subjects will be instructed to maintain their habitual diet and physical activity. During the study period, body weight will be monitored routinely to ensure that baseline weight does not fluctuate by more than 1kg. Prior to day 1, day 42 and day 84, a three-day diet record will be administered to subjects to calculate basal energy intake.
Study design The study is a randomized, controlled, parallel-arm trial precedes by a 1-week run-in period with control treatment to assess compliance, acceptability and to determine baseline values.After the run-in period, participants will be randomized to either the control group or treatment group for three months. Each treatment phase will be 3 months in duration. At baseline, day 42 and day 84, clinical assessment (body weight, waist/hip circumference, blood pressure, pulse) will be preformed and blood samples will be collected. Urinary will be collected on baseline, day 42 and day 84. Fecal samples will be collected on baseline and day 84. Three days dietary records and appetite sensation ratings will be collected three times during the study (baseline, day 42 and day 84).
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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Increased waist circumference : ≥ 90 cm for men and ≥ 80 cm for women
- •Plus 1 or more of the remaining criteria:
- •Elevated TG level ≥ 1.7 mmo/L
- •Reduced HDL-Cholesterol < 1.03 mmol/L in men and < 1.29 mmol/L in women)
- •Fasting glucose ≥ 5.6 mmol/L
- •Systolic/diastolic blood pressure ≥ 130/85 mmHg.
排除标准
- •Taking lipid lowering medications
- •With known or unknown peanut allergy (or any peanut containing products)
- •Thyroid disease
- •Diabetes mellitus
- •Kidney disease
- •Liver disease
- •Cardiovascular disease or cancer
- •Pregnant or lactating women
- •Heavy alcohol consumption (>14 drinks/week)
研究组 & 干预措施
Control
Daily consumption of isocaloric matched snack food for 12 weeks Intervention: Other: High Carbohydrate Snack
干预措施: Control (Dietary Supplement)
Peanut
Daily consumption of 2 servings of roasted peanuts for 12 weeks Intervention: Dietary Supplement: Roasted peanuts
干预措施: Peanut (Dietary Supplement)
结局指标
主要结局
Blood glucose
时间窗: Blood glucose will be measured at day 84.
glucose, insulin, HbA1c
次要结局
- Blood lipids level(Blood lipids level will be measured at day 84.)
- Polyphenol metabolites(Polyphenol metabolites will be measured at day 84.)
- Blood Inflammatory status(Inflammatory biomarkers will be measured at day 84.)
- Assessment of appetite and other hunger sensations(Appetite and other hunger sensations will be measured at day 84.)
- Microbiome(Micriobiome will be measured at day 84.)
研究者
Vasanti Malik
PI
Harvard School of Public Health (HSPH)