Fibre suppLements fOR Pre-diAbetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 4
- 主要终点
- HbA1c levels
研究概览
简要总结
This trial will investigate whether a powdered fibre mix helps maintain healthy blood glucose levels in participants with pre-diabetes, where high blood sugar is a risk of diabetes.
详细描述
Pre-diabetes is characterised by high blood glucose levels, high plasma cholesterol, low-density lipoprotein (LDL) and high-density lipoprotein (HDL). Dietary fibre consumption has been hypothesised to improve these metabolic parameters through the viscous properties, and the production of short-chain fatty acids (SCFA) in the intestine.
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
- Single (Participant)
盲法说明
Participants will be randomised to Placebo or the Myota Metabolic Regulator, with a 1:1 randomisation ratio stratified by gender and BMI.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able and willing to provide informed consent
- •Have a Body Mass Index (BMI) of at least 25 kg/m2
- •Men or post menopausal* women aged 18-70
- •Identified as pre-diabetic (HbA1c 6.0% (42 mmol/mol) to 6.4% (47 mmol/ mol)) within the previous 12 months
- •Baseline HbA1c result within the range 5.8% (40 mmol/mol) - 6.5% (48 mmol/mol)
- •Willing to complete in clinic blood tests and a participant trial survey
- •Have access to a smartphone or a computer
排除标准
- •Receiving medication to treat Type 1 or Type 2 diabetes in the previous 6 months
- •Have a Body Mass Index (BMI) <25 kg/m2 and >45 kg/m2
- •Loss of more than 5% body weight in last 3 months
- •Current participation in weight loss program or planned in the next 16 weeks
- •Steroid use (except for over the counter NSAID's, topical steroids and inhalers)
- •Severe hepatic diseases (including chronic persistent hepatitis, liver cirrhosis or the co-occurrence of positive hepatitis B virus surface antigen and abnormal hepatic transaminase (serum concentrations of alanine transaminase or aspartate transaminase >2.5× the upper normal limit))
- •Continuous antibiotic use for >3 days within 4 weeks prior to enrolment
- •Continuous use of weight-loss drug for within 3 months of study entry
结局指标
主要结局
HbA1c levels
时间窗: 16 weeks
To compare the effect of Myota's Metabolic Regulator versus placebo on Hemoglobin A1c (HbA1c) levels
次要结局
- Insulin(16 and 24 weeks)
- Inflammatory markers(16 and 24 weeks)
- Blood pressure(16 and 24 weeks)
- Lipid profile(16 and 24 weeks)
- HbA1c levels(24 weeks)
- Overall safety of the Myota Metabolic Regulator(Weeks 1-4)
- Insulin sensitivity(16 weeks)
- To investigate intervention adherence(24 weeks)
- To investigate usability(16 and 24 weeks)
研究者
Dr John Luke Twelves
Medical Director (CRO)
Myota GmbH