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Effects of Barley Based Food Products on Metabolism and Gut Microflora

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02427555
Recruitment Status : Completed
First Posted : April 28, 2015
Last Update Posted : May 17, 2016
Sponsor:
Collaborator:
Göteborg University
Information provided by (Responsible Party):
Anne Nilsson, Lund University

Tracking Information
First Submitted Date  ICMJE April 17, 2015
First Posted Date  ICMJE April 28, 2015
Last Update Posted Date May 17, 2016
Study Start Date  ICMJE April 2015
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2015)
  • Changes in glucose regulation [ Time Frame: 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
  • Changes in colonic microbiota composition after intervention with barley [ Time Frame: 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
  • nucleotide polymorphisms (SNP in TCF7L2) [ Time Frame: at baseline ]
    investigate nucleotide polymorphisms that associate with cardiometabolic traits, in particular the SNP in TCF7L2
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02427555 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Barley Based Food Products on Metabolism and Gut Microflora
Official Title  ICMJE Effects of Barley Based Food Products on Metabolism and Gut Microflora
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Healthy Subjects
Intervention  ICMJE
  • Other: Barley kernel bread
    3 days intervention with barley kernel bread
  • Other: white wheat bread
    3 days intervention with white wheat bread
Study Arms  ICMJE
  • Experimental: Barley kernel bread
    Intervention: Other: Barley kernel bread
  • Sham Comparator: Whit wheat flour bread
    Intervention: Other: white wheat bread
Publications * Sandberg J, Kovatcheva-Datchary P, Björck I, Bäckhed 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 22, 2015)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02427555
Other Study ID Numbers  ICMJE AFC-Y8-2015
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Anne Nilsson, Lund University
Study Sponsor  ICMJE Lund University
Collaborators  ICMJE Göteborg University
Investigators  ICMJE
Principal Investigator: Anne Nilsson, PhD Food for Health Science Centre, Medicon Village, Lund University
PRS Account Lund University
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP