The Effect of Long-term Momordica Charantia Supplementation on Blood Glucose Levels
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- change in fasting plasma glucose concentrations
研究概览
简要总结
The study is a parallel, double blind, controlled trial in which study participants will receive a 12-week intervention with 3.6 g/d dried bitter-gourd supplements or a reference intervention with 3.6 g/d dried cucumber supplements. Research subjects will come to the research facility for a test day on four occasions, with an interval of 4 weeks. The main study parameter is fasting levels of plasma glucose.
详细描述
Bitter gourd (BG) (Momordica charantia) is a highly nutritive vegetable from the cucumber family. The objective is to assess the impact of 12-weeks of BG supplementation on blood glucose levels in subjects with impaired fasting glucose levels. In a previous trial (Bitter-Zoet NL70259.081.19) the short-term effects of BG (4 weeks) were studied, but no effect was observed. In the current trial a different BG cultivar is chosen, the intervention period is prolonged, the dosage per day is higher and study subjects with slightly higher fasting blood glucose levels will be included. The study is a parallel, double blind, controlled trial in which study participants will receive a 12-week intervention with 3.6 g/d dried bitter-gourd supplements or a reference intervention with 3.6 g/d dried cucumber supplements. Research subjects will come to the research facility for a test day on four occasions, with an interval of 4 weeks. The main study parameter is fasting levels of plasma glucose. Secondary outcome measures are glucose tolerance, HbA1c, insulin and HOMA-IR and HOMA-B levels.
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, Care Provider, Investigator)
盲法说明
Supplements will be labeled A and B by a scientist who is not involved in this trial.
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 40-75yrs
- •BMI >25 kg/m2
- •Having a fasting glucose >6.1 mmol/L
排除标准
- •Use of medication/supplements that may influence the study results, such as metformin, gliclazide, glimepiride, tolbutamide, insulin, sitagliptin (DPP4 inhibitor), liraglutide (GLP-1 agonist), acarbose, repaglinide, pioglitazone, corticosteroids (systemically) , SGLT-2 inhibitors, (judged by our research physician)
- •Having a fasting glucose >11.0 mmol/L
- •History of gastro-intestinal surgery or having (serious) gastro-intestinal complaints
- •History of liver dysfunction (cirrhosis, hepatitis) or liver surgery
- •Reported slimming, medically prescribed or other extreme diets
- •Reported weight loss or weight gain of > 5 kg in the month prior to pre-study screening
- •Not willing to give up blood donation during the study
- •Current smokers
- •Alcohol intake ≥14 glasses (women) or >21 glasses (men) of alcoholic beverages per week, on average
- •pregnant or lactating (self-reported)
- •Abuse of illicit drugs (soft- and hard drugs)
- •Food allergies for products that we use in the study
- •Participation in another clinical trial at the same time
- •Being an employee of the Food, Health & Consumer Research group of Wageningen Food & Biobased Research or dept. human nutrition and health of Wageningen University.
结局指标
主要结局
change in fasting plasma glucose concentrations
时间窗: Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4)
marker for glucose metabolism
次要结局
- change in HOMA-B levels(Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4))
- change in HbA1c(Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4))
- change in 2hour plasma glucose concentrations after a 75-gram OGTT(Baseline (before supplementation (T0)) and after 12 weeks (T4))
- change in insulin(Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4))
- change in HOMA-IR levels(Baseline (before supplementation (T0)), after 4 weeks (T2), 8 weeks (T3) and 12 weeks (T4))
研究者
Diederik Esser
Project leader clinical trials
Wageningen University and Research