Dietary Fibre and Metabolic Benefits

Glucose Tolerance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03423381
• Other study ID #: 2017-03575
• Status: Completed
• Phase: N/A
• Start date: May 30, 2018
• Est. completion date: February 28, 2019

Study information

• Verified date: March 2019
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: February 28, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glucose Tolerance

Intervention

Other:
• Cereal product 1
Cereal products based on rye, barley, wheat, oat, and corn
• Cereal product 2
Cereal products based on rye, barley, wheat, oat, and corn
• Cereal product 3
Cereal products based on rye, barley, wheat, oat, and corn
• Cereal product 4
Cereal products based on rye, barley, wheat, oat, and corn
• Cereal product 5
Cereal products based on rye, barley, wheat, oat, and corn
• Control product
A cereal based product with low concentrations of df

Locations

Country	Name	City	State
Sweden	Food Technology, engineering and Nutrition, LTH, Lund University	Lund

Sponsors (3)

Lead Sponsor	Collaborator
Lund University	Öste Venture AB, Vinnova

Country where clinical trial is conducted

Sweden, 

References & Publications (6)

Kovatcheva-Datchary P, Nilsson A, Akrami R, Lee YS, De Vadder F, Arora T, Hallen A, Martens E, Björck I, Bäckhed 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. — View Citation

Nilsson AC, Johansson-Boll EV, Björck 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. — View Citation

Nilsson AC, Ostman EM, Holst JJ, Björck 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. — View Citation

Nilsson AC, Östman EM, Knudsen KE, Holst JJ, Björck 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. — View Citation

Sandberg JC, Björck 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. — View Citation

Sandberg JC, Björck 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Subjective appetite sensations	determined with VAS (visual analogue scale) scales (0-100 mm)	0-14 h after intake
Other	mood (valence and activity)	determined with VAS scales (0-100 mm)	0-14 h after intake
Other	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
Other	breath hydrogen concentrations	indicator of gut fermentation	0-14 h after intake
Primary	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	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
Secondary	gut microbiota composition	effects on gut microbiota composition after intake of prebiotics	first stool delivered from14 h after intake
Secondary	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
Secondary	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
Secondary	plasma GLP-2	gut hormone involved in gut mucosa integrity	0-14 h after intake
Secondary	plasma SCFA (short-chain fatty acid)	colonic fermentation metabolites	0-14 h after intake
Secondary	blood lipids	cholesterol and free fatty acids in plasma	0-14 h after intake
Secondary	plasma adiponectin	hormone involved in metabolic regulation	0-14 h after intake
Secondary	plasma BDNF (Brain-derived neurotrophic factor)	signal protein important for brain functions, but also involved in metabolic regulation	0-14 h after intake
Secondary	plasma neurotensin	a neuro peptide peptides involved in appetite and metabolic regulation	0-14 h after intake
Secondary	plasma Nesfatin-1	a neuro peptide that participates in the regulation of hunger and fat storage.	0-14 h after intake