Effects of Barley Based Food Products on Metabolism and Gut Microflora

Not Applicable

Completed

• Conditions: Healthy Subjects
• Interventions: Other: Barley kernel bread; Other: white wheat bread

• Registration Number: NCT02427555
• Lead Sponsor: Lund University

Brief Summary

The main objective is to investigate gut microflora composition in relation to cardiometabolic risk markers, and to investigate the effects of 3 days intervention with a barley kernel based product on these variables.

Detailed Description

100 subjects were invited to deliver faecal samples. From this cohort 40 subjects were chosen based on their gut microflora composition to participate in the Barley intervention.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-17
• Study First Submitted QC: 2015-04-22
• Study First Posted: 2015-04-28
• Status Verified: 2016-05
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Last Update Submitted: 2016-05-16
• Last Update Posted: 2016-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• healthy men and women between 50-79 years and
• BMI between 19-28.

Exclusion Criteria

• fasting blood glucose concentrations > 6,1 mmol/L,
• known metabolic disorders or gastrointestinal diseases or other disorders that can interfere with the results of the study.
• furthermore, the subjects should be non-smokers and
• consume a normal (non-vegetarian) diet as is recommended by the Nordic dietary guidelines.
• antibiotics or probiotics should not have been taken during four weeks prior to faeces donation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Barley kernel bread	Barley kernel bread	-
Whit wheat flour bread	white wheat bread	-

Primary Outcome Measures

Name	Time	Method
Changes in colonic microbiota composition after intervention with barley	Changes in colonic microbiota composition after 3 days intervention with a barley based bread in comparison to 3 days intervention with a white wheat based bread	Gut microbiota composition are characterised after interventions with barley based bread and white wheat bread, respectively
Changes in glucose regulation	Changes in fasting and postprandial blood glucose concentrations after 3 days intervention with a barley based bread in comparison to 3 days intervention with a white wheat based bread	blood glucose concentrations are measured fasting and postprandially a standardised breakfast after interventions with barley based bread and white wheat bread, respectively
nucleotide polymorphisms (SNP in TCF7L2)	at baseline	investigate nucleotide polymorphisms that associate with cardiometabolic traits, in particular the SNP in TCF7L2

Trial Locations

Locations (1)

Food for Health Science Centre, Medicon Village, Lund University; 🇸🇪 Lund, Sweden