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

This study has been completed.
Sponsor:
Collaborators:
VINNOVA
Oatly AB
Lantmannen Food R&D
Danisco Sugar AB/Fibrex
Information provided by:
Lund University
ClinicalTrials.gov Identifier:
NCT01005342
First received: October 29, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

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

Condition Intervention
Hypoglycemia
Hyperglycemia
 Other: Oat bran
Other: Spray-dried oat drink
Other: Rye bran
Other: Sugar beet fiber
Other: Mixture of fiber
Other: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Official Title: The Influence of Dietary Fibre-rich Meals on Gene Expression in Leukocytes and Postprandial Glucose and Lipid Response in Healthy Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Lund University:

Primary Outcome Measures:
  • Changed gene expression profile by fiber-rich meals [ Time Frame: 2 h after meal intake ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lowering of postprandial glucose by fiber-rich meals [ Time Frame: 0-180 min after meal intake ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: May 2007
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mixture of fiber
Single intake of a mixture of spray-dried oat drink, rye bran and sugar beet fiber
 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).
Experimental: Sugar beet fiber
Single intake of sugar beet fiber
 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
Experimental: Rye bran
Single intake of rye bran
 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
Experimental: Oat bran
Single intake of oat bran
 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
Experimental: Spray-dried oat drink
Single intake of spray-dried oat drink
 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
Placebo Comparator: Control
Single intake of a meal with no added fiber
 Other: Control
No fiber was added to control meal (250 g black-currant beverage)

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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01005342

Locations
Sweden
Lund University
Lund, Sweden, SE-221 00
Sponsors and Collaborators
Lund University
VINNOVA
Oatly AB
Lantmannen Food R&D
Danisco Sugar AB/Fibrex
Investigators
Study Director: Gunilla Önning, Dr. Lund University
  More Information

Publications:

Responsible Party: Gunilla Önning, Lund University
ClinicalTrials.gov Identifier: NCT01005342     History of Changes
Other Study ID Numbers: KCROS07
Study First Received: October 29, 2009
Last Updated: October 29, 2009
Health Authority: Sweden: Regional Ethical Review Board
Sweden: Medical Products Agency

Keywords provided by Lund University:
gene expression
oats
rye
sugar beet fiber
glucose
 insulin
triglyceride
decreased postprandial glucose
decreased postprandial insulin
glycemic index

Additional relevant MeSH terms:
Hyperglycemia
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on June 17, 2013