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

Hyperglycemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01005342
• Other study ID #: KCROS07
• Status: Completed
• Phase: N/A
• First received: October 29, 2009
• Last updated: October 29, 2009
• Start date: May 2007
• Est. completion date: June 2007

Study information

• Verified date: October 2009
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review BoardSweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Hyperglycemia
• Hypoglycemia

Intervention

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

Locations

Country	Name	City	State
Sweden	Lund University	Lund

Sponsors (5)

Lead Sponsor	Collaborator
Lund University	Danisco Sugar AB/Fibrex, Lantmannen Food R&D, Oatly AB, Vinnova

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changed gene expression profile by fiber-rich meals		2 h after meal intake	No
Secondary	Lowering of postprandial glucose by fiber-rich meals		0-180 min after meal intake	No