NCT01005342

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 30, 2009

Completed
Last Updated

October 30, 2009

Status Verified

October 1, 2009

Enrollment Period

1 month

First QC Date

October 29, 2009

Last Update Submit

October 29, 2009

Conditions

HypoglycemiaHyperglycemia

Keywords

gene expressionoatsryesugar beet fiberglucoseinsulintriglyceridedecreased postprandial glucosedecreased postprandial insulinglycemic index

Outcome Measures

Primary Outcomes (1)

  • Changed gene expression profile by fiber-rich meals

    2 h after meal intake

Secondary Outcomes (1)

  • Lowering of postprandial glucose by fiber-rich meals

    0-180 min after meal intake

Study Arms (6)

Mixture of fiber

EXPERIMENTAL

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

Other: Mixture of fiber

Sugar beet fiber

EXPERIMENTAL

Single intake of sugar beet fiber

Other: Sugar beet fiber

Rye bran

EXPERIMENTAL

Single intake of rye bran

Other: Rye bran

Oat bran

EXPERIMENTAL

Single intake of oat bran

Other: Oat bran

Spray-dried oat drink

EXPERIMENTAL

Single intake of spray-dried oat drink

Other: Spray-dried oat drink

Control

PLACEBO COMPARATOR

Single intake of a meal with no added fiber

Other: Control

Interventions

Oat branOTHER

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
Oat bran
Spray-dried oat drinkOTHER

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
Spray-dried oat drink
Rye branOTHER

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
Rye bran
Sugar beet fiberOTHER

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
Sugar beet fiber
Mixture of fiberOTHER

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).

Mixture of fiber
ControlOTHER

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

Control

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI 18-30

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lund University

Lund, SE-221 00, Sweden

Location

Related 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.

    PMID: 19415409RESULT

MeSH Terms

Conditions

HypoglycemiaHyperglycemiaInsulin Resistance

Interventions

beta-GlucansarabinoxylanSucrosePectins

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

GlucansPolysaccharidesCarbohydratesDisaccharidesOligosaccharidesSugarsBiopolymersPolymersMacromolecular SubstancesPlant ExtractsPlant PreparationsBiological ProductsComplex Mixtures

Study Officials

  • Gunilla Ă–nning, Dr.

    Lund University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 29, 2009

First Posted

October 30, 2009

Study Start

May 1, 2007

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

October 30, 2009

Record last verified: 2009-10

Locations

SE(1)