Effects of Barley Based Food Products on Metabolism and Gut Microflora

Healthy Subjects Clinical Trial

Official title:

Effects of Barley Based Food Products on Metabolism and Gut Microflora

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02427555
• Other study ID #: AFC-Y8-2015
• Status: Completed
• Phase: N/A
• First received: April 17, 2015
• Last updated: May 16, 2016
• Start date: April 2015
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Central Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 70 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Other:
• Barley kernel bread
3 days intervention with barley kernel bread
• white wheat bread
3 days intervention with white wheat bread

Locations

Country	Name	City	State
Sweden	Food for Health Science Centre, Medicon Village, Lund University	Lund

Sponsors (2)

Lead Sponsor	Collaborator
Lund University	Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in glucose regulation	blood glucose concentrations are measured fasting and postprandially a standardised breakfast after interventions with barley based bread and white wheat bread, respectively	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	No
Primary	Changes in colonic microbiota composition after intervention with barley	Gut microbiota composition are characterised after interventions with barley based bread and white wheat bread, respectively	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	No
Primary	nucleotide polymorphisms (SNP in TCF7L2)	investigate nucleotide polymorphisms that associate with cardiometabolic traits, in particular the SNP in TCF7L2	at baseline	No