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CompletedNCT01005342Updated Oct 30, 2009

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

An interventional study of Oat bran and Spray-dried oat drink in Hypoglycemia and Hyperglycemia, sponsored by Lund University. Completed at 1 site in Sweden. Open to participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-10-30.

Sponsored by Lund University · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
All
01

Study 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
Read the 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.

02

Conditions studied

  • Hypoglycemia
  • Hyperglycemia

Keywords

  • gene expression
  • oats
  • rye
  • sugar beet fiber
  • glucose
  • insulin
  • triglyceride
  • decreased postprandial glucose
  • decreased postprandial insulin
  • glycemic index
03

In context

Hypoglycemia

640 studies on the registry are indexed under Hypoglycemia; 86 are open to participants now.

This study's enrollment of 18 is below the median of 29 across 471 interventional studies indexed under Hypoglycemia.

Browse Hypoglycemia studies →

Lead sponsor

Lund University is the lead sponsor of 230 studies on the registry; 37 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • BMI 18-30

Exclusion criteria

Exclusion Criteria:

  • pregnancy
  • breastfeeding
  • diabetes mellitus
  • hepatitis B
  • blood lipid lowering pharmaceuticals
  • intolerance or allergy to cereals or sugar beet fiber
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Participant)
Enrollment
18 participants (actual)

Study arms

  • Experimental
    Mixture of fiber

    Single intake of a mixture of spray-dried oat drink, rye bran and sugar beet fiber

    Other: Mixture of fiber

  • Experimental
    Sugar beet fiber

    Single intake of sugar beet fiber

    Other: Sugar beet fiber

  • Experimental
    Rye bran

    Single intake of rye bran

    Other: Rye bran

  • Experimental
    Oat bran

    Single intake of oat bran

    Other: Oat bran

  • Experimental
    Spray-dried oat drink

    Single intake of spray-dried oat drink

    Other: Spray-dried oat drink

  • Placebo comparator
    Control

    Single intake of a meal with no added fiber

    Other: Control

Interventions

  • OtherOat 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).

    Also known as: Oats, Beta-glucan

  • OtherSpray-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).

    Also known as: Oats, Oat milk, Beta-glucan

  • OtherRye 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).

    Also known as: Rye, Arabinoxylan

  • OtherSugar 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).

    Also known as: Sugar beet, Pectin

  • OtherMixture 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).

  • OtherControl

    No fiber was added to control meal (250 g black-currant beverage)

06

What researchers measure

Primary outcomes

  1. Changed gene expression profile by fiber-rich meals

    Time frame: 2 h after meal intake

Secondary outcomes

  1. Lowering of postprandial glucose by fiber-rich meals

    Time frame: 0-180 min after meal intake

07

Study locations

1 site
  • Lund University
    Lund, SE-221 00, Sweden
08

References and documents

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. PubMed 19415409 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 30, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01005342
Lead sponsor
Lund University
Collaborators
Vinnova, Oatly AB, Lantmannen Food R&D, Danisco Sugar AB/Fibrex
First posted
Oct 30, 2009
Start date
May 2007
Primary completion
Jun 2007
Completion
Jun 2007
Last update
Oct 30, 2009

Study contacts

Gunilla Önning, Dr.
study director · Lund University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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