The Effects of Rye Crisp Bread on Appetite and Metabolic Function

NCT ID: NCT02011217

Last Updated: 2013-12-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2013-09-30

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.

Detailed Description

The short-term effects (up to 4 hours after intake) of rye crisp breads on subjective appetite and metabolism will be evaluated using a randomized cross-over study design. Each participant will consume three different breakfasts consisting of two different rye crisp breads and one wheat crisp bread on three different occasions separated by a 1 week wash-out period. Participants will rate subjective appetite (satiety, hunger and desire to eat) by using a visual analogue scale (VAS) every 30 min during a 4-hour period, starting 30 min before breakfast. Blood samples will be collected before breakfast and at regular intervals throughout the day for analysis of glucose, insulin and hormone levels. Gastric emptying rate will also be evaluated using paracetamol as an indicator. Glucose and hormonal responses will be related to subjective appetite and to differences in composition of the breakfasts.

Conditions

Appetite Regulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Rye crisp bread A

Group Type: EXPERIMENTAL

Rye crisp bread B

Intervention Type: OTHER

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.

Wheat crisp bread C

Intervention Type: OTHER

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 B

Group Type: EXPERIMENTAL

Rye crisp bread A

Intervention Type: OTHER

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.

Wheat crisp bread C

Intervention Type: OTHER

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.

Wheat crisp bread C

Group Type: EXPERIMENTAL

Rye crisp bread A

Intervention Type: OTHER

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 B

Intervention Type: OTHER

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.

Interventions

Rye crisp bread A

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.

Intervention Type: OTHER

Rye crisp bread B

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.

Intervention Type: OTHER

Wheat crisp bread C

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Habitual breakfast eaters

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Uppsala University

OTHER

Sponsor Role: collaborator

Swedish University of Agricultural Sciences

OTHER

Sponsor Role: lead

Responsible Party

Isabella Lee

PhD student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rikard K Landberg, Ass. Prof.

Role: PRINCIPAL_INVESTIGATOR

Swedish University of Agricultural Sciences

Locations

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

Uppsala, Uppsala County, Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 25826373 (View on PubMed)

Other Identifiers

SLU-IL-S2

Identifier Type: -

Identifier Source: org_study_id