MedDataX Logo

The Effects of Rye Crisp Bread on Appetite and Metabolic Function

NCT ID: NCT02011217

Last Updated: 2013-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

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

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Appetite Regulation

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Rye Dietary Fibre Bread Crisp bread Appetite Satiety Hunger Desire to eat Metabolism Glucose Insulin Gut hormones Gastric emptying rate

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Meet the organizations funding or collaborating on the study and learn about their roles.

Uppsala University

OTHER

Sponsor Role collaborator

Swedish University of Agricultural Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Isabella Lee

PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Rikard K Landberg, Ass. Prof.

Role: PRINCIPAL_INVESTIGATOR

Swedish University of Agricultural Sciences

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Uppsala, Uppsala County, Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

References

Explore related publications, articles, or registry entries linked to this study.

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

Review additional registry numbers or institutional identifiers associated with this trial.

SLU-IL-S2

Identifier Type: -

Identifier Source: org_study_id