Dietary Fibre and Metabolic Benefits

Validation of a New Antidiabetic Food Concept Based on Modulation of the Gut Microbiota

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

Study Overview

• Status: Completed
• Conditions: Glucose Tolerance
• Intervention / Treatment: Other: Cereal product 1; Other: Cereal product 2; Other: Cereal product 3; Other: Cereal product 4; Other: Cereal product 5; Other: Control product

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Lund, Sweden, 22100
    • Food Technology, engineering and Nutrition, LTH, Lund University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Cereal product 1; Cereal products based on rye, barley, wheat, oat, and corn
Experimental: 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.	Other: Cereal product 2; Cereal products based on rye, barley, wheat, oat, and corn
Experimental: 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.	Other: Cereal product 3; Cereal products based on rye, barley, wheat, oat, and corn
Experimental: 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.	Other: Cereal product 4; Cereal products based on rye, barley, wheat, oat, and corn
Experimental: 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.	Other: Cereal product 5; Cereal products based on rye, barley, wheat, oat, and corn
Placebo Comparator: 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.	Other: Control product; A cereal based product with low concentrations of df

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood glucose regulation	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.	0-14 h after intake

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective appetite sensations	determined with VAS (visual analogue scale) scales (0-100 mm)	0-14 h after intake
mood (valence and activity)	determined with VAS scales (0-100 mm)	0-14 h after intake
Energy intake	ad libitum intake at a second meal after intake of test products	4 h after intake of a test product or the control product
breath hydrogen concentrations	indicator of gut fermentation	0-14 h after intake

Collaborators and Investigators

• Sponsor: Lund University
• Collaborators: Vinnova; Öste Venture AB
• Investigators: Principal Investigator: Anne Nilsson, PhD, Food Technology, engineering, and Nutrition, LTH, Lund University

Publications and helpful links

General Publications

• Sandberg JC, Bjorck IM, Nilsson AC. Rye-Based Evening Meals Favorably Affected Glucose Regulation and Appetite Variables at the Following Breakfast; A Randomized Controlled Study in Healthy Subjects. PLoS One. 2016 Mar 18;11(3):e0151985. doi: 10.1371/journal.pone.0151985. eCollection 2016.
• Nilsson AC, Ostman EM, Knudsen KE, Holst JJ, Bjorck IM. A cereal-based evening meal rich in indigestible carbohydrates increases plasma butyrate the next morning. J Nutr. 2010 Nov;140(11):1932-6. doi: 10.3945/jn.110.123604. Epub 2010 Sep 1.
• Nilsson AC, Johansson-Boll EV, Bjorck IM. Increased gut hormones and insulin sensitivity index following a 3-d intervention with a barley kernel-based product: a randomised cross-over study in healthy middle-aged subjects. Br J Nutr. 2015 Sep 28;114(6):899-907. doi: 10.1017/S0007114515002524. Epub 2015 Aug 11.
• Kovatcheva-Datchary P, Nilsson A, Akrami R, Lee YS, De Vadder F, Arora T, Hallen A, Martens E, Bjorck I, Backhed F. Dietary Fiber-Induced Improvement in Glucose Metabolism Is Associated with Increased Abundance of Prevotella. Cell Metab. 2015 Dec 1;22(6):971-82. doi: 10.1016/j.cmet.2015.10.001. Epub 2015 Nov 6.
• Sandberg JC, Bjorck IME, Nilsson AC. Effects of whole grain rye, with and without resistant starch type 2 supplementation, on glucose tolerance, gut hormones, inflammation and appetite regulation in an 11-14.5 hour perspective; a randomized controlled study in healthy subjects. Nutr J. 2017 Apr 21;16(1):25. doi: 10.1186/s12937-017-0246-5.
• Nilsson AC, Ostman EM, Holst JJ, Bjorck IM. Including indigestible carbohydrates in the evening meal of healthy subjects improves glucose tolerance, lowers inflammatory markers, and increases satiety after a subsequent standardized breakfast. J Nutr. 2008 Apr;138(4):732-9. doi: 10.1093/jn/138.4.732.

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2018
• Primary Completion (Actual): February 28, 2019
• Study Completion (Actual): February 28, 2019

Study Registration Dates

• First Submitted: December 29, 2017
• First Submitted That Met QC Criteria: January 30, 2018
• First Posted (Actual): February 6, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2019
• Last Update Submitted That Met QC Criteria: March 21, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 2017-03575

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No