Dietary Fibre and Metabolic Benefits

Not Applicable

Completed

• Conditions: Glucose Tolerance
• Interventions: Other: Cereal product 1; Other: Cereal product 2; Other: Cereal product 4; Other: Control product; Other: Cereal product 3; Other: Cereal product 5

• Registration Number: NCT03423381
• Lead Sponsor: Lund University

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 Timeline

• Study First Submitted: 2017-12-29
• Study First Submitted QC: 2018-01-30
• Study First Posted: 2018-02-06
• Study Start: 2018-05-30
• Primary Completion: 2019-02-28
• Study Completion: 2019-02-28
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-21
• Last Update Posted: 2019-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• healthy adults
• BMI<30
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cereal product 1	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.
Cereal product 2	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.
Cereal product 4	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.
Control product	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.
Cereal product 3	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.
Cereal product 5	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.

Primary Outcome Measures

Name	Time	Method
Blood glucose regulation	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 Outcome Measures

Name	Time	Method
plasma GLP-1 (glucagon-like peptide-1 ), PYY (peptide tyrosine tyrosine), Ghrelin	0-14 h after intake	Gastro-intestinale hormones involved in appetite and metabolic regulation
plasma adiponectin	0-14 h after intake	hormone involved in metabolic regulation
blood lipids	0-14 h after intake	cholesterol and free fatty acids in plasma
plasma BDNF (Brain-derived neurotrophic factor)	0-14 h after intake	signal protein important for brain functions, but also involved in metabolic regulation
plasma Nesfatin-1	0-14 h after intake	a neuro peptide that participates in the regulation of hunger and fat storage.
serum insulin	0-14 h after intake	Postprandial serum insulin concentrations (incremental area under the curve) acute after intake of the test products and at forthcoming meals within 14 h after consumption of test products.
gut microbiota composition	first stool delivered from14 h after intake	effects on gut microbiota composition after intake of prebiotics
plasma SCFA (short-chain fatty acid)	0-14 h after intake	colonic fermentation metabolites
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	Inflammatory markers in blood
plasma GLP-2	0-14 h after intake	gut hormone involved in gut mucosa integrity
plasma neurotensin	0-14 h after intake	a neuro peptide peptides involved in appetite and metabolic regulation

Trial Locations

Locations (1)

Food Technology, engineering and Nutrition, LTH, Lund University; 🇸🇪 Lund, Sweden