Clinical trial NCT03423381: Dietary Fibre and Metabolic Benefits
Official title: Validation of a New Antidiabetic Food Concept Based on Modulation of the Gut Microbiota
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glucose Tolerance
Lead sponsor: Lund University
Sponsor class: OTHER
Collaborators: name: Vinnova
name: Öste Venture AB
First posted: 2018-02-06
Enrollment: 18
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover randomised
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Blood glucose regulation
timeFrame: 0-14 h after intake
Secondary outcomes:
measure: serum insulin
timeFrame: 0-14 h after intake
measure: gut microbiota composition
timeFrame: first stool delivered from14 h after intake
measure: plasma GLP-1 (glucagon-like peptide-1 ), PYY (peptide tyrosine tyrosine), Ghrelin
timeFrame: 0-14 h after intake
measure: plasma: CRP (C reactive protein ), IL (interleukin)-6, IL-18, IL-8, IL-1, IL-10, LBP (lipopolysaccharide-binding protein), (PAI-1plasminogen activator inhibitor)
timeFrame: 0-14 h after intake
measure: plasma GLP-2
timeFrame: 0-14 h after intake
measure: plasma SCFA (short-chain fatty acid)
timeFrame: 0-14 h after intake
measure: blood lipids
timeFrame: 0-14 h after intake
measure: plasma adiponectin
timeFrame: 0-14 h after intake
measure: plasma BDNF (Brain-derived neurotrophic factor)
timeFrame: 0-14 h after intake
measure: plasma neurotensin
timeFrame: 0-14 h after intake
measure: plasma Nesfatin-1
timeFrame: 0-14 h after intake
Other outcomes:
measure: Subjective appetite sensations
timeFrame: 0-14 h after intake
measure: mood (valence and activity)
timeFrame: 0-14 h after intake
measure: Energy intake
timeFrame: 4 h after intake of a test product or the control product
measure: breath hydrogen concentrations
timeFrame: 0-14 h after intake
Locations:
city: Lund
country: Sweden
facility: Food Technology, engineering and Nutrition, LTH, Lund University
Study officials:
affiliation: Food Technology, engineering, and Nutrition, LTH, Lund University
name: Anne Nilsson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.