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Influence of Dietary Fiber-rich Meals on Gene Expression and Postprandial Glucose and Lipid Response

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ClinicalTrials.gov Identifier: NCT01005342
Recruitment Status : Completed
First Posted : October 30, 2009
Last Update Posted : October 30, 2009
Sponsor:
Collaborators:
Vinnova
Oatly AB
Lantmannen Food R&D
Danisco Sugar AB/Fibrex
Information provided by:
Lund University

Tracking Information
First Submitted Date  ICMJE October 29, 2009
First Posted Date  ICMJE October 30, 2009
Last Update Posted Date October 30, 2009
Study Start Date  ICMJE May 2007
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 29, 2009)
Changed gene expression profile by fiber-rich meals [ Time Frame: 2 h after meal intake ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2009)
Lowering of postprandial glucose by fiber-rich meals [ Time Frame: 0-180 min after meal intake ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Influence of Dietary Fiber-rich Meals on Gene Expression and Postprandial Glucose and Lipid Response
Official Title  ICMJE The Influence of Dietary Fibre-rich Meals on Gene Expression in Leukocytes and Postprandial Glucose and Lipid Response in Healthy Subjects
Brief Summary

The aim of this study is to

  • Measure the effect on gene expression in leukocytes from a meal rich in oat bran
  • Investigate the postprandial glucose, insulin and triglyceride responses after intake of meals containing fiber from different sources (oat, rye and sugar beet fiber) or a meal containing a mixture of these three fibers
Detailed Description

Dietary fiber has long been known to give beneficial health effects. Yet, the understanding of how fiber-rich meals regulate molecular events at a gene level is limited. Also, few studies have compared the effects of different fiber sources on postprandial responses and hardly any study the effects of fiber mixtures in the same meal, even though this is more similar to regular eating habits.

Healthy subjects will come to the study center after an overnight fast, to ingest breakfasts randomly enriched with different fiber. The meals contains either spray-dried oat drink, rye bran, sugar beet fiber a mixture of these three fibers, oat bran or no added fiber (control). All meals are adjusted to contain the same total amount of available carbohydrates and fat. Blood leukocytes for gene expression profiling were taken before and 2 h after consumption while blood samples for analysis of postprandial glucose, insulin and triglyceride levels were taken every 30 min during 3 h.

NuGO Affymetrix Human Genechip NuGO_Hs1a520180 are used for the microarray analysis and analysis is performed with linear mixed models and enrichment analysis to identify functional gene sets that responded to the specific oat bran effect.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Condition  ICMJE
  • Hypoglycemia
  • Hyperglycemia
Intervention  ICMJE
  • Other: Oat bran
    82 g oat bran was added to 250 ml blackcurrant beverage with pulp to give 5 g soluble fiber (12.6 g total fiber).
    Other Names:
    • Oats
    • Beta-glucan
  • Other: Spray-dried oat drink
    62 g spray-dried oat drink was added to 250 ml blackcurrant beverage with pulp to give 2.7 g soluble fiber (3.3 g total fiber).
    Other Names:
    • Oats
    • Oat milk
    • Beta-glucan
  • Other: Rye bran
    31 g rye bran was added to 250 ml blackcurrant beverage with pulp to give 1.7 g soluble fiber (12 g total fiber).
    Other Names:
    • Rye
    • Arabinoxylan
  • Other: Sugar beet fiber
    19 g sugar beet fiber was added to 250 ml blackcurrant beverage with pulp to give 5 g soluble fiber (12 g total fiber).
    Other Names:
    • Sugar beet
    • Pectin
  • Other: Mixture of fiber
    38 g spray-dried oat drink, 30 g rye bran and 6 g sugar beet fiber were added to 250 ml blackcurrant beverage with pulp to give 5 g soluble fiber (18 g total fiber).
  • Other: Control
    No fiber was added to control meal (250 g black-currant beverage)
Study Arms  ICMJE
  • Experimental: Mixture of fiber
    Single intake of a mixture of spray-dried oat drink, rye bran and sugar beet fiber
    Intervention: Other: Mixture of fiber
  • Experimental: Sugar beet fiber
    Single intake of sugar beet fiber
    Intervention: Other: Sugar beet fiber
  • Experimental: Rye bran
    Single intake of rye bran
    Intervention: Other: Rye bran
  • Experimental: Oat bran
    Single intake of oat bran
    Intervention: Other: Oat bran
  • Experimental: Spray-dried oat drink
    Single intake of spray-dried oat drink
    Intervention: Other: Spray-dried oat drink
  • Placebo Comparator: Control
    Single intake of a meal with no added fiber
    Intervention: Other: Control
Publications * Ulmius M, Johansson A, Onning G. The influence of dietary fibre source and gender on the postprandial glucose and lipid response in healthy subjects. Eur J Nutr. 2009 Oct;48(7):395-402. doi: 10.1007/s00394-009-0026-x. Epub 2009 May 5.

*   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: October 29, 2009)
18
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2007
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • BMI 18-30

Exclusion Criteria:

  • pregnancy
  • breastfeeding
  • diabetes mellitus
  • hepatitis B
  • blood lipid lowering pharmaceuticals
  • intolerance or allergy to cereals or sugar beet fiber
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 65 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 NCT01005342
Other Study ID Numbers  ICMJE KCROS07
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gunilla Önning, Lund University
Study Sponsor  ICMJE Lund University
Collaborators  ICMJE
  • Vinnova
  • Oatly AB
  • Lantmannen Food R&D
  • Danisco Sugar AB/Fibrex
Investigators  ICMJE
Study Director: Gunilla Önning, Dr. Lund University
PRS Account Lund University
Verification Date October 2009

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