Effect of Three Weeks Consumption of Rye Porridge Breakfast

Effect of Three Weeks Consumption of Rye Porridge Breakfast on 24 h Appetite Profile, and Acute Effect on OCTT and Breath Hydrogen

Acute hunger-reducing effects (8h) has been documented for rye porridge breakfast compared with iso-caloric referenced refined wheat reference breakfast. The primary aim of the current study is to investigate whether this effects remains at regular consumption. A secondary aim is to compare the orocecal transit time (OCTT) between the two breakfasts.

Study Overview

Status

Unknown

Conditions

Detailed Description

The study is randomised and cross-over. During two 3-wk periods, separated by a 3-4-wks wash out, subjects will consume test breakfasts. During one of the periods test breakfast includes rye flake porridge and during the other period test breakfast include bread made from sifted wheat. The breakfast meals will be similar in calorie-, protein-, carbohydrate- and fat content. For all other days but 1, 8 and 22 of respective test period, the breakfast foods will be handed out to the participants along with instructions to exchange their ordinary breakfast with the test foods. During day 1, 8 and 22 the breakfasts will be served at the study centre.

Following measurements will be made:

  1. Subjective ratings of hunger, satiety and desire to eat during 24 h after breakfast on day 1, 8 and 22 during each 3-wk intervention period.
  2. on day 8 during each intervention period, orocecal transit time and breath hydrogen will be measured after intake of the breakfast.
  3. 3 day weighed food diaries will be taken at three occasions: at baseline and during the second week of each dietary intervention period.

Study Type

Interventional

Enrollment (Anticipated)

26

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

      • Uppsala, Sweden, 75183
        • Good Food Practice

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

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • man or woman aged between 20 and 60 years;
  • body mass index (BMI) 18-27 kg/m2;
  • habit of consuming breakfast, lunch and dinner every day;
  • and willingness to comply with the study procedures.

Exclusion Criteria:

  • intake of medicine likely to affect appetite or food intake;
  • any medical condition involving the gastrointestinal tract;
  • eating disorder;
  • smoking;
  • consumption of more than three cups of coffee per day;
  • change in body weight more than 10% during three months prior to screening;
  • consumption of any restricted diet such as vegan, gluten-free, slimming;
  • pregnancy, lactation or wish to become pregnant during the study period;
  • any known intolerance towards salazopyrin and similar substances

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rye porrige breakfast
A breakfast consisting of either active (rye porridge) or control (wheat bread) is given during 2 3-wk intervention periods in a randomized cross-over design. The two dietary intervention periods are separated by a 3-4 wks wash out.
Active Comparator: Refined wheat reference bread breakfast
A breakfast consisting of either active (rye porridge) or control (wheat bread) is given during 2 3-wk intervention periods in a randomized cross-over design. The two dietary intervention periods are separated by a 3-4 wks wash out.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Appetite profile
Time Frame: 24 h
Subjective feelings of appetite (hunger, satiety and desire to eat) were assessed every 30 min, starting just before breakfast at 08:00 and continuing until bedtime. The last recording was made before breakfast on the following day.
24 h

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
energy intake
Time Frame: 3 days
Weighed food records was completed by the subjects during baseline and each intervention phase.
3 days
Orocecal transit time
Time Frame: 8 h
Salazopyrin (two 500 mg tabelts) is taken after breakfast. The substance passes the stomach and small intestine unabsorbed and is broken down by microbial fermentation in the colon to sulphapyridine and 5-ASA. Sulphapyridine appearance in the blood is then measured as an indicator of colon arrival time.
8 h
Breath hydrogen
Time Frame: 8 h
8 h

Collaborators and Investigators

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

Investigators

  • Study Director: Per Åman, Professor, 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.

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

March 1, 2010

Primary Completion (Anticipated)

July 1, 2010

Study Completion (Anticipated)

July 1, 2010

Study Registration Dates

First Submitted

May 4, 2010

First Submitted That Met QC Criteria

May 4, 2010

First Posted (Estimate)

May 5, 2010

Study Record Updates

Last Update Posted (Estimate)

May 5, 2010

Last Update Submitted That Met QC Criteria

May 4, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Other Study ID Numbers

  • SIV829

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.

Clinical Trials on Obesity Prevention

Clinical Trials on dietary intervention (rye porridge or wheat bread)

3
Subscribe