Effects of Barley Based Food Products on Metabolism and Gut Microflora

NCT ID: NCT02427555

Last Updated: 2016-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-05-31

Brief Summary

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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

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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.

Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Barley kernel bread

Group Type EXPERIMENTAL

Barley kernel bread

Intervention Type OTHER

3 days intervention with barley kernel bread

Whit wheat flour bread

Group Type SHAM_COMPARATOR

white wheat bread

Intervention Type OTHER

3 days intervention with white wheat bread

Interventions

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Barley kernel bread

3 days intervention with barley kernel bread

Intervention Type OTHER

white wheat bread

3 days intervention with white wheat bread

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Göteborg University

OTHER

Sponsor Role collaborator

Lund University

OTHER

Sponsor Role lead

Responsible Party

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Anne Nilsson

Associate professor, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anne Nilsson, PhD

Role: PRINCIPAL_INVESTIGATOR

Food for Health Science Centre, Medicon Village, Lund University

Locations

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Food for Health Science Centre, Medicon Village, Lund University

Lund, , Sweden

Site Status

Countries

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Sweden

References

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Sandberg J, Kovatcheva-Datchary P, Bjorck I, Backhed F, Nilsson A. Abundance of gut Prevotella at baseline and metabolic response to barley prebiotics. Eur J Nutr. 2019 Sep;58(6):2365-2376. doi: 10.1007/s00394-018-1788-9. Epub 2018 Jul 25.

Reference Type DERIVED
PMID: 30046942 (View on PubMed)

Other Identifiers

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AFC-Y8-2015

Identifier Type: -

Identifier Source: org_study_id

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