Validation of a New Antidiabetic Food Concept Based on Modulation of the Gut Microbiota
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Lund University
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Blood glucose regulation
Study Overview
Brief Summary
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
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 20 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •healthy adults
- •non smokers
- •consuming a non-vegetarian diet that follows the Nordic guidances
Exclusion Criteria
- •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.
Arms & Interventions
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.
Intervention: 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.
Intervention: 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.
Intervention: 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.
Intervention: 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.
Intervention: 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.
Intervention: Control product (Other)
Outcomes
Primary Outcomes
Blood glucose regulation
Time Frame: 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.
Secondary Outcomes
- plasma GLP-1 (glucagon-like peptide-1 ), PYY (peptide tyrosine tyrosine), Ghrelin(0-14 h after intake)
- plasma adiponectin(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 SCFA (short-chain fatty acid)(0-14 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)
Investigators
Anne Nilsson
Associate professor, PhD
Lund University