Validation of a New Antidiabetic Food Concept Based on Modulation of the Gut Microbiota
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Blood glucose regulation
研究概览
简要总结
The aim of the project is to study the connection between bacterial fermentation in the colon of prebiotic substrates and effects on systemic metabolism and appetite i healthy humans
详细描述
The purpose with this project is to study the association between bacterial fermentation in the colon of specific mixtures of cereal dietary fiber and effects on systemic metabolism and appetite regulation. For this purpose, short term studies are performed in healthy adult subjects. Different cereals, cereal blends and from cereal extracted dietary fiber will be studied, as well as effects of different processing of the cereals. Cardiometabolic test markers and colonic fermentation metabolites will be followed up to 14 h after intake of the test substrates, and gut microbiota composition will be determined prior to and after the interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy adults
- •non smokers
- •consuming a non-vegetarian diet that follows the Nordic guidances
排除标准
- •fasting blood glucose >6.1 mmol/L
- •known cardio-metabolic disease (e.g. diabetes, hypertension, metabolic syndrome), gastro-intestinal disorders such as IBS (irritable bowel syndrome) that can interfere with the study results, food allergies. Further no antibiotics or probiotics should have been consumed within 4 weeks prior to and during the study.
研究组 & 干预措施
Cereal product 1
Cereal based müsli no. 1, made from typical Swedish cereals. All experimental products have different types and amounts of dietary fibre (df). The test portion is consumed as a single evening meal prior to determinations of test variables in the morning.
干预措施: Cereal product 1 (Other)
Cereal product 2
Cereal based muesli no. 2 made from typical Swedish cereals. All experimental products have different types and amounts of df. The test portion is consumed as a single evening meal prior to determinations of test variables in the morning.
干预措施: Cereal product 2 (Other)
Cereal product 3
Cereal based muesli no.3 made from typical Swedish cereals. All experimental products have different types and amounts of df.The test portion is consumed as a single evening meal prior to determinations of test variables in the morning.
干预措施: Cereal product 3 (Other)
Cereal product 4
Cereal based muesli no. 4 made from typical Swedish cereals. All experimental products have different types and amounts of df. The test portion is consumed as a single evening meal prior to determinations of test variables in the morning.
干预措施: Cereal product 4 (Other)
Cereal product 5
Cereal based muesli no. 5 made from typical Swedish cereals. All experimental products have different types and amounts of df. The test portion is consumed as a single evening meal prior to determinations of test variables in the morning.
干预措施: Cereal product 5 (Other)
Control product
A cereal based product with low concentrations of df. The control portion is consumed as a single evening meal prior to determinations of test variables in the morning.
干预措施: Control product (Other)
结局指标
主要结局
Blood glucose regulation
时间窗: 0-14 h after intake
Postprandial blood glucose regulation (incremental area under the curve) acute after intake of the test products and at forthcoming meals within 14 h after consumption of test products.
次要结局
- plasma GLP-1 (glucagon-like peptide-1 ), PYY (peptide tyrosine tyrosine), Ghrelin(0-14 h after intake)
- plasma adiponectin(0-14 h after intake)
- plasma SCFA (short-chain fatty acid)(0-14 h after intake)
- blood lipids(0-14 h after intake)
- plasma BDNF (Brain-derived neurotrophic factor)(0-14 h after intake)
- plasma Nesfatin-1(0-14 h after intake)
- serum insulin(0-14 h after intake)
- gut microbiota composition(first stool delivered from14 h after intake)
- plasma: CRP (C reactive protein ), IL (interleukin)-6, IL-18, IL-8, IL-1, IL-10, LBP (lipopolysaccharide-binding protein), (PAI-1plasminogen activator inhibitor)(0-14 h after intake)
- plasma GLP-2(0-14 h after intake)
- plasma neurotensin(0-14 h after intake)
研究者
Anne Nilsson
Associate professor, PhD
Lund University