NCT06951386招募中不适用
The Impact of 12 Weeks Intervention With Plant-based Oat Drink Rich in Short-chain Fatty Acids on Postprandial Lipidemia in Individuals at Risk for Metabolic Syndrome
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- KU Leuven
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Fasting triglycerides
研究概览
简要总结
During this study, the effect of short-chain fatty acids on blood lipaedemia, glycemia, anthropometrics, blood pressure and energy expenditure will be investigated.
详细描述
The goal of this study is to investigate the impact of consuming every day a drink enriched with short-chain fatty acids for 12 weeks on the cardiometabolic health in individuals at risk of metabolic syndrome. This means the investigators are looking for people with overweight and disrupted cholesterol, high blood pressure or elevated blood glucose. The individuals will consume for 12 weeks a drink either enriched with SCFA or a control drink (randomly allocated). Before and after this period (study visit 1 and 4), a study visit will take place in which metabolic parameters will be measured such as blood pressure, body weight, waist- and hip circumference, body composition, energy expenditure, glucose, insulin and blood lipids. After 4 and 8 weeks, anthropometrics, blood pressure and body composition will be measured during a short study visit (study visit 2 and 3).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male and female participants
- •central obesity ( BMI ≥ 25 kg/m² or waist circumference ≥ 80 cm for women/ ≥ 94 cm for men)
- •One additional risk factor for metabolic syndrome:
- •Insulin resistance (HOMA-IR ≥ 1.7 or fasting glucose ≥ 100 mg/dl)
- •Triglyceride concentration ≥ 150 mg/dl
- •HDL-cholesterol < 40 mg/dl for women/ < 50 mg/dl for men
- •Systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 85 mmHg
- •knowledge of English
排除标准
- •gastrointestinal disorders such as IBD, IBS, celiac disease, chronic constipation, chronic diarrhoea
- •history of abdominal surgery, except for appendectomy
- •Use of antihypertensive, cholesterol lowering, glucose-regulating drugs and corticosteroids
- •Use of antibiotics 3 months prior to the start or during the study
- •Use of probiotics and prebiotics 2 weeks prior to the start of the study/ during the study
- •Being on weight loss, gluten-free, lactose-free or vegan diet
- •Pregnancy, lactation or wish to become pregnant
- •Previous or current substance/ alcohol dependence or abuse
- •Hyper- or hypothyroidism
- •Allergy or intolerance to oat milk
研究组 & 干预措施
Drink enriched with short-chain fatty acids
Active Comparator
Treatment with enriched drink
干预措施: with short-chain fatty acids enriched drink (Dietary Supplement)
Control drink
Placebo Comparator
Treatment with control drink
干预措施: unenriched oat drink (Dietary Supplement)
结局指标
主要结局
Fasting triglycerides
时间窗: During study visit 1(baseline) and visit 4 (end of intervention, week 12)
Triglyceride concentrations will be measured in fasting state
次要结局
- Blood pressure(Baseline, week 4, week 8 and week 12)
- 24 hour diet recall(Before the intervention and during week 4, 8 and 12 of the intervention)
- Fasting insulinemic response(During study visit 1 (baseline) and 4 (12 weeks))
- Anthropometrics: waist and hip circumference(Baseline, week 4, week 8 and week 12)
- Gut hormone: PYY(During study visit 1 (baseline) and 4 (12 weeks) (up to 6 hours))
- Cytokines(During study visit 1 (baseline) and 4 (12 weeks))
- Postprandial glycemia(During study visit 1 (baseline) and 4 (12 weeks) (up to 6 hours))
- Waist to hip ratio(During all 4 study visits (0, 4,8 and 12 weeks) (fasted state))
- Insulin resistance: HOMA-IR(During study visit 1 (baseline) and 4 (12 weeks))
- Incretin hormone GLP1(During study visit 1 (baseline) and 4 (12 weeks) (up to 6 hours))
- Fasting glycemia(During study visit 1 (baseline) and 4 (12 weeks))
- Fasting energy expenditure(During study visit 1 (baseline) and 4 (12 weeks))
- Anthropometrics: body weight(Baseline, week 4, week 8 and week 12)
- HbA1c(During study visit 1 (baseline) and 4 (12 weeks))
- Short-chain fatty acids in stool(Within 2 days prior to study visit 1 (baseline) and 4 (12 weeks))
- Postprandial lipaedemia: triglycerides(During study visit 1 (baseline) and 4 (12 weeks) (up to 6 hours))
- Short-chain fatty acids in blood(During study visit 1 (baseline) and 4 (12 weeks) (up to 6 hours))
- Appetite measurements(During study visit 1 (baseline) and 4 (12 weeks) (up to 6 hours))
- Physical activity measurement(At the end of study visit 1 (baseline) and 4 (12 weeks))
- Postprandial energy expenditure(During study visit 1 (baseline) and 4 (12 weeks) (up to 3 hours))
- Fasting blood lipids(During study visit 1 (baseline) and 4 (12 weeks))
- Metabolomics(During study visit 1 (baseline) and 4 (12 weeks))
- LBP(During study visit 1 (baseline) and 4 (12 weeks))
- HOMA-B(During study visit 1 (baseline) and 4 (12 weeks))
- Insulinogenic index(During study visit 1 (baseline) and 4 (12 weeks))
- Postprandial insulin(During study visit 1 (baseline) and 4 (12 weeks) (up to 6 hours))
- Postprandial lipaedemia: total, LDL and HDL cholesterol(During study 1 (baseline) and study 4 (12 weeks) (up to 6 hours))
- Postprandial lipaedemia: free fatty acids(During study 1 (baseline) and study 4 (12 weeks) (up to 6 hours))
- % fat mass(During all 4 study visits (0, 4,8 and 12 weeks) (fasted state))
- kg fat mass(During all 4 study visits (0, 4,8 and 12 weeks) (fasted state))
- fat free mass (kg)(During all 4 study visits (0, 4,8 and 12 weeks) (fasted state))
- Dry lean weight (kg)(During all 4 study visits (0, 4,8 and 12 weeks) (fasted state))
- Water percentage(During all 4 study visits (0, 4,8 and 12 weeks) (fasted state))
- Total body water (L)(During all 4 study visits (0, 4,8 and 12 weeks) (fasted state))
- Average energy requirements(During all 4 study visits (0, 4,8 and 12 weeks) (fasted state))
- Basal metabolic rate(During all 4 study visits (0, 4,8 and 12 weeks) (fasted state))
- basal metabolic rate (BMR)/ body weight(During all 4 study visits (0, 4,8 and 12 weeks) (fasted state))
- BMI(During all 4 study visits (0, 4,8 and 12 weeks) (fasted state))
- Resistance during bioelectrical impedance(During all 4 study visits (0, 4,8 and 12 weeks) (fasted state))
- Free fatty acids in fasting state(During study visit 1 (baseline) and 4 (after 12 weeks))
研究者
研究点 (1)
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