Clinical trial NCT01005342: Influence of Dietary Fiber-rich Meals on Gene Expression and Postprandial Glucose and Lipid Response
Official title: The Influence of Dietary Fibre-rich Meals on Gene Expression in Leukocytes and Postprandial Glucose and Lipid Response in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoglycemia
Hyperglycemia
Keywords: gene expression
oats
rye
sugar beet fiber
glucose
insulin
triglyceride
decreased postprandial glucose
decreased postprandial insulin
glycemic index
Lead sponsor: Lund University
Sponsor class: OTHER
Collaborators: name: Vinnova
name: Oatly AB
name: Lantmannen Food R&D
name: Danisco Sugar AB/Fibrex
First posted: 2009-10-30
Enrollment: 18
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL

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.

Eligibility 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

Primary outcomes:
measure: Changed gene expression profile by fiber-rich meals
timeFrame: 2 h after meal intake
Secondary outcomes:
measure: Lowering of postprandial glucose by fiber-rich meals
timeFrame: 0-180 min after meal intake
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Lund University
Study officials:
affiliation: Lund University
name: Gunilla Önning, Dr.
role: STUDY_DIRECTOR
References:
citation: 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.