The Effects of Personalized Dietary Guidance to Increase the Intake of Fibre-rich Foods on Cardiometabolic Risk Profile in Individuals with Type 2 Diabetes. (in Dutch: Voed Je Beter Met Diabetes Type 2)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- Cardiometabolic risk profile (DIAL risk score)
研究概览
简要总结
This is a randomized controlled trial to examine whether personalized guidance to increase the consumption of fiber rich food items according to the Dutch dietary guidelines, compared to usual care, improves health of individuals with type 2 diabetes.
详细描述
Previous interventions with fibre supplements show promising results among individuals with type 2 diabetes, but wether these effects are similar when higher fiber intake is achieved through diet and not through supplements remains unclear.
The primary objective of this study is to investigate the effects of personalized dietary guidance to increase the intake of fibre-rich foods, as recommended in the Dutch dietary guidelines, on cardiometabolic risk profile in individuals who have type 2 diabetes, compared to usual care after six months.
The study is a parallel randomized trial over a period of twelve months, including an intervention period of six months and a follow up period of six months. The study population consists of adults with non-insulin-dependent type 2 diabetes, diagnosed by a medical doctor at least 6 months prior to study enrolment.
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 (Outcomes Assessor)
盲法说明
The nature of the intervention does not allow for blinding of the participants or researchers. After data collection, the database will be coded by an independent researcher to ensure that data analysis is conducted in a blinded way.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of type 2 diabetes made by a medical doctor at least 6 months prior to study enrolment
- •Willing and able to follow dietary intervention
- •Willing to participate in both intervention and control group
- •Living at a reasonable distance from the research center at Wageningen University & Research (WUR) (i.e.maximum of ± 1 hour away)
排除标准
- •Currently treated with insulin therapy
- •Recently (< 6 months) or currently being under supervision of a dietician
- •Pregnant or breast-feeding
- •History of bariatric surgery, including gastric banding
- •Current participation in a study with an investigational drug or dietary intervention
- •Excessive alcohol consumption (more than 14 units for males/7 units for females per week) or drug use
- •Clinical disorders that could interfere with the intervention (e.g. gastro-intestinal disorders, auto-immune diseases, psychiatric disorders, uncontrolled heart diseases, serious neurological disorders, renal failure or cancer)
- •Not able to speak and understand the Dutch language
- •No general practitioner
- •Working at the department of Human Nutrition and Health at Wageningen University & Research
结局指标
主要结局
Cardiometabolic risk profile (DIAL risk score)
时间窗: Change from baseline at 6 months
The change in cardiovascular risk based on observed changes in HbA1c, LDL-cholesterol and systolic blood pressure. DIAL risk score ranges from 0 to 100%, with higher scores indicating a higher risk.
次要结局
- Fasting insulin(baseline, 6 months, 12 month)
- Leg muscle strength(baseline, 6 months, 12 months)
- Cardiometabolic risk profile (DIAL risk score)(Change from baseline at 12 months)
- Liver function(baseline, 6 months, 12 months)
- Health index score(baseline, 3 months, 6 months, 12 months)
- Hand grip strength(baseline, 6 months, 12 months)
- Balance score(baseline, 6 months, 12 months)
- Skeletal muscle fat infiltration(baseline, 6 months, 12 months)
- Productivity(baseline, 3 months, 6 months, 12 months)
- Dietary intake(baseline, 3 months, 6 months, 12 months)
- Flexibility(baseline, 6 months, 12 months)
- Body weight (in kilograms)(baseline, 6 months, 12 months)
- Blood pressure(baseline, 6 months, 12 months)
- Estimated Glomerular Filtration Rate (eGFR)(baseline, 6 months, 12 months)
- Urinary albumin levels(baseline, 6 months, 12 months)
- Inflammatory markers(baseline, 6 months, 12 months)
- Self efficacy score(baseline, 3 months, 6 months, 12 months)
- Body mass index (kg/m^2)(baseline, 6 months, 12 months)
- Blood lipids(baseline, 6 months, 12 months)
- Micronutrient status(baseline, 6 months, 12 months)
- Food literacy(baseline, 3 months, 6 months, 12 months)
- HbA1c(baseline, 6 months, 12 month)
- Fasting glucose(baseline, 6 months, 12 month)
- Sleep quality score(baseline, 3 months, 6 months, 12 months)
- Cardiovascular condition(baseline, 6 months, 12 months)
- Waist circumference(baseline, 6 months, 12 months)
- C-peptide(baseline, 6 months, 12 month)
- Quality of life score(baseline, 3 months, 6 months, 12 months)
- Positive health score(baseline, 3 months, 6 months, 12 months)
- Medical consumption(baseline, 3 months, 6 months, 12 months)
研究者
Marianne Geleijnse
prof.dr. JM (Marianne) Geleijnse
Wageningen University