The Effects of Rye Crisp Bread on Appetite and Metabolic Function (S2RBAM)

December 9, 2013 updated by: Isabella Lee, Swedish University of Agricultural Sciences

The Effects of Rye Crisp Bread on Subjective Appetite and Metabolic Function After Short-term Consumption

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Uppsala, Sweden, SE-751 85
        • Paediatric Research Facility; The Children's Hospital at Uppsala University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rye crisp bread A
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.
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.
Experimental: Rye crisp bread B
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.
Other: 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.
Experimental: Wheat crisp bread C
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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective Appetite Profiles during 4 hours
Time Frame: -30, 0, 30, 60, 90, 120, 150, 180, 210, 240 minutes
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastric Emptying Rate during 4 hours
Time Frame: -15, 15, 35, 65, 95, 125, 185, 230 minutes
Paracetamol (1 g) taken with breakfast. The appearance of paracetamol in the blood is directly related to the rate of gastric emptying.
-15, 15, 35, 65, 95, 125, 185, 230 minutes
Hormonal Responses during 4 hours
Time Frame: -15, 15, 35, 65, 95, 125, 185, 230 minutes
Glucagon, glucagon-like peptide-1 (GLP-1), glucose-dependent insulino-tropic polypeptide (GIP), peptide YY (PYY), cholecystokinin (CCK), leptin and ghrelin are measured in plasma samples.
-15, 15, 35, 65, 95, 125, 185, 230 minutes
Glucose and Insulin Responses during 4 hours
Time Frame: -15, 15, 35, 65, 95, 125, 185, 230 minutes
Glucose and insulin are measured in plasma samples.
-15, 15, 35, 65, 95, 125, 185, 230 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swedish University of Agricultural Sciences

Collaborators

Uppsala University

Investigators

  • Principal Investigator: Rikard K Landberg, Ass. Prof., Swedish University of Agricultural Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

November 6, 2013

First Submitted That Met QC Criteria

December 9, 2013

First Posted (Estimate)

December 13, 2013

Study Record Updates

Last Update Posted (Estimate)

December 13, 2013

Last Update Submitted That Met QC Criteria

December 9, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SLU-IL-S2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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