The Impact of Daily Intake of Short-chain Fatty Acids on Cardiometabolic Risk Factors in Individuals at Risk for Metabolic Syndrome

Официальное название

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

Обзор

During this study, the effect of short-chain fatty acids on blood lipaedemia, glycemia, anthropometrics, blood pressure and energy expenditure will be investigated.

Подробное описание

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).

Вмешательства

• Пищевая добавка with short-chain fatty acids enriched drink
  Oat-based drink enriched with 15 g/L short-chain fatty acids
• Пищевая добавка unenriched oat drink
  Oat-based drink

Первичные конечные точки

• Fasting triglycerides [Срок оценки: During study visit 1(baseline) and visit 4 (end of intervention, week 12)]

Вторичные конечные точки (12)

• Fasting glycemia [Срок оценки: During study visit 1 (baseline) and 4 (12 weeks)]
• Fasting energy expenditure [Срок оценки: During study visit 1 (baseline) and 4 (12 weeks)]
• Anthropometrics: body weight [Срок оценки: Baseline, week 4, week 8 and week 12]
• Blood pressure [Срок оценки: Baseline, week 4, week 8 and week 12]
• Insulin resistance: HOMA-IR [Срок оценки: During study visit 1 (baseline) and 4 (12 weeks)]
• HbA1c [Срок оценки: During study visit 1 (baseline) and 4 (12 weeks)]
• Short-chain fatty acids in stool [Срок оценки: Within 2 days prior to study visit 1 (baseline) and 4 (12 weeks)]
• Incretin hormone GLP1 [Срок оценки: During study visit 1 (baseline) and 4 (12 weeks) (up to 6 hours)]
• Cytokines [Срок оценки: During study visit 1 (baseline) and 4 (12 weeks)]
• 24 hour diet recall [Срок оценки: Before the intervention and during week 4, 8 and 12 of the intervention]
• Postprandial glycemia [Срок оценки: During study visit 1 (baseline) and 4 (12 weeks) (up to 6 hours)]
• Postprandial lipaedemia: triglycerides [Срок оценки: During study visit 1 (baseline) and 4 (12 weeks) (up to 6 hours)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Фундаментальное исследование

Центры проведения

Бельгия · 1 центр

• KU Leuven/ UZ Leuven — Leuven

Идентификаторы

NCT: NCT06951386 · S69712

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗