NCT02011217

Brief Summary

The aim of this study is to contribute to a better understanding of how dietary fibre in rye affects appetite and metabolic processes. We will evaluate how the intake of rye crisp breads affects appetite, insulin secretion and glucose levels in the blood in healthy humans. We will also investigate microstructural properties of the crisp breads with microscopy, as well as to characterize the food products with respect to the content of dietary fibre and certain bioactive compounds. The aim is also to try to elucidate how observed effects on appetite are related to changes in insulin and glucose levels, appetite related hormonal signals and microstructural properties to verify findings from previous studies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2013

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

August 1, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 13, 2013

Completed
Last Updated

December 13, 2013

Status Verified

December 1, 2013

Enrollment Period

1 month

First QC Date

November 6, 2013

Last Update Submit

December 9, 2013

Conditions

Appetite Regulation

Keywords

RyeDietary FibreBreadCrisp breadAppetiteSatietyHungerDesire to eatMetabolismGlucoseInsulinGut hormonesGastric emptying rate

Outcome Measures

Primary Outcomes (1)

  • Subjective Appetite Profiles during 4 hours

    Subjective feelings of appetite (satiety, hunger and desire to eat) assessed by visual analogue scale (VAS).

    -30, 0, 30, 60, 90, 120, 150, 180, 210, 240 minutes

Secondary Outcomes (3)

  • Gastric Emptying Rate during 4 hours

    -15, 15, 35, 65, 95, 125, 185, 230 minutes

  • Hormonal Responses during 4 hours

    -15, 15, 35, 65, 95, 125, 185, 230 minutes

  • Glucose and Insulin Responses during 4 hours

    -15, 15, 35, 65, 95, 125, 185, 230 minutes

Study Arms (3)

Rye crisp bread A

EXPERIMENTAL
Other: Rye crisp bread BOther: Wheat crisp bread C

Rye crisp bread B

EXPERIMENTAL
Other: Rye crisp bread AOther: Wheat crisp bread C

Wheat crisp bread C

EXPERIMENTAL
Other: Rye crisp bread AOther: Rye crisp bread B

Interventions

Rye crisp bread AOTHER

In a randomized cross-over design each subject receive one of three iso-caloric breakfasts on three different occasions, separated by 1 week wash-out period.

Rye crisp bread BWheat crisp bread C
Rye crisp bread BOTHER

In a randomized cross-over design each subject receive one of three iso-caloric breakfasts on three different occasions, separated by 1 week wash-out period.

Rye crisp bread AWheat crisp bread C
Wheat crisp bread COTHER

In a randomized cross-over design each subject receive one of three iso-caloric breakfasts on three different occasions, separated by 1 week wash-out period.

Rye crisp bread ARye crisp bread B

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Habitual breakfast eaters

You may not qualify if:

  • Pregnancy, lactation or wishing to become pregnant during the study period
  • Dieting
  • Weightloss
  • Eating disorder
  • Hyperglycemic
  • Hyperinsulinemic
  • Thyroid disease
  • Metabolic issues
  • Diabetes
  • Physical or psychological problems with eating
  • Food intolerance/allergies to foods included in the study
  • Intolerance/allergy to paracetamol
  • Heavy smokers
  • Recent or concurrent participation in a dietary intervention research study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Paediatric Research Facility; The Children's Hospital at Uppsala University Hospital

Uppsala, Uppsala County, SE-751 85, Sweden

Location

Related Publications (1)

  • Johansson DP, Lee I, Riserus U, Langton M, Landberg R. Effects of unfermented and fermented whole grain rye crisp breads served as part of a standardized breakfast, on appetite and postprandial glucose and insulin responses: a randomized cross-over trial. PLoS One. 2015 Mar 31;10(3):e0122241. doi: 10.1371/journal.pone.0122241. eCollection 2015.

    PMID: 25826373DERIVED

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Rikard K Landberg, Ass. Prof.

    Swedish University of Agricultural Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

November 6, 2013

First Posted

December 13, 2013

Study Start

August 1, 2013

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

December 13, 2013

Record last verified: 2013-12

Locations

SE(1)