NCT04303468已完成不适用
The Effects of a GABA Supplement Versus a Placebo on Glucose Tolerance and Blood Pressure in Prediabetics
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Postprandial glycaemic response during a 2 hour oral glucose tolerance test (OGTT)
研究概览
简要总结
In this double-blind parallel placebo controlled intervention study the effects of 3 times daily 500 mg gamma-aminobutyric acid (GABA) supplementation on glucose tolerance and cardiovascular health will be assessed in prediabetics.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 50 and 70
- •BMI higher or equal to 27 kg/m2
- •Impaired fasting glucose (fasting glucose ≥ 6.1 and ≤ 6.9 mmol/L) or/and
- •Impaired glucose tolerance (glucose levels ≥ 7.8 and ≤ 11.1 mmol/L, 2-hours after an OGTT or/and glucose levels ≥8.6 mmol/L, 1-hour after an OGTT)
排除标准
- •Has been diagnosed with diabetes
- •Having other conditions, like liver, pancreatic, cardiovascular, gastro-intestinal or endocrine diseases, that could influence the study results
- •Use of medications or supplements that could influence the study results
- •Sensitive to medical skin adhesives
- •More than 5kg weight change in the past 12 weeks
- •Excessive alcohol consumption (>21 glasses/week for men and >14 glasses/week for women on average)
- •Being an employee of Wageningen University, division Human Nutrition and Health
- •Currently a research subject in other research
研究组 & 干预措施
Placebo
Placebo Comparator
The placebo consists of capsules containing powdered cellulose.
干预措施: Placebo (Other)
GABA
Experimental
GABA is a nutrient commonly present in our diet in for example tomatoes and potatoes. It is also commercially sold as dietary supplement. A dose of 500 mg, 3 times daily is used
干预措施: GABA (Dietary Supplement)
结局指标
主要结局
Postprandial glycaemic response during a 2 hour oral glucose tolerance test (OGTT)
时间窗: blood will be drawn at baseline and after 30, 60 and 120 minutes, before and after the 12 weeks intervention
A 2 hour oral glucose tolerance test with 75gr glucose
次要结局
- Acute effects of GABA on blood pressure(for 24 hours during which GABA is taken 3 times, each time before the main meal)
- Acute effects of GABA on postprandial glucose(2 hours, after a single administration of 500 mg GABA)
- Postprandial insulin and glucagon response during a 2 hour OGTT,(blood will be drawn at baseline and after 30, 60 and 120 minutes, before and after the 12 weeks intervention)
- Plasma free fatty acids(before and after the 12 weeks intervention)
- HbA1c(before and after the 12 weeks intervention)
- Glucose variability(5 days during which they eat their habitual diet, before and after the 12 weeks intervention)
- Blood pressure(Dynamic measurement: 24 hours, before and after the 12 weeks intervention)
- Heart rate(before and after the 12 weeks intervention)
- Concentrion of markers of inflammation in blood(before and after the 12 weeks intervention)
- Concentration of triglycerides in blood(before and after the 12 weeks intervention)
- Concentration of LDL and HDL cholesterol in blood(before and after the 12 weeks intervention)
- Concentration of ALAT and ASAT in blood(before and after the 12 weeks intervention)
- Sleep quality(before and after the 12 weeks intervention)
- Feelings of depression(before and after the 12 weeks intervention)
- Feelings of anxiety(before and after the 12 weeks intervention)
- Plasma GABA concentration(before and after the 12 weeks intervention)
- Plasma glutamate concentration(before and after the 12 weeks intervention)
研究者
研究点 (1)
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