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

October 29, 2009 updated by: Lund University

The Influence of Dietary Fibre-rich Meals on Gene Expression in Leukocytes and Postprandial Glucose and Lipid Response in Healthy Subjects

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Lund, Sweden, SE-221 00
        • Lund University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
  • Beta-glucan
  • Oat milk
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changed gene expression profile by fiber-rich meals
Time Frame: 2 h after meal intake
2 h after meal intake

Secondary Outcome Measures

Outcome Measure
Time Frame
Lowering of postprandial glucose by fiber-rich meals
Time Frame: 0-180 min after meal intake
0-180 min after meal intake

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lund University

Collaborators

Vinnova
Oatly AB
Lantmannen Food R&D
Danisco Sugar AB/Fibrex

Investigators

  • Study Director: Gunilla Önning, Dr., Lund University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (ACTUAL)

June 1, 2007

Study Completion (ACTUAL)

June 1, 2007

Study Registration Dates

First Submitted

October 29, 2009

First Submitted That Met QC Criteria

October 29, 2009

First Posted (ESTIMATE)

October 30, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

October 30, 2009

Last Update Submitted That Met QC Criteria

October 29, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KCROS07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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