Effect of Three Weeks Consumption of Rye Porridge Breakfast

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Swedish University of Agricultural Sciences.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Lantmannen Research and Development
Good Food Practice, Sweden
Information provided by:
Swedish University of Agricultural Sciences
ClinicalTrials.gov Identifier:
NCT01117363
First received: May 4, 2010
Last updated: NA
Last verified: May 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Obesity Prevention
Other: dietary intervention (rye porridge or wheat bread)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effect of Three Weeks Consumption of Rye Porridge Breakfast on 24 h Appetite Profile, and Acute Effect on OCTT and Breath Hydrogen

Resource links provided by NLM:


Further study details as provided by Swedish University of Agricultural Sciences:

Primary Outcome Measures:
  • Appetite profile [ Time Frame: 24 h ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • energy intake [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    Weighed food records was completed by the subjects during baseline and each intervention phase.

  • Orocecal transit time [ Time Frame: 8 h ] [ Designated as safety issue: No ]
    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.

  • Breath hydrogen [ Time Frame: 8 h ] [ Designated as safety issue: No ]

Estimated Enrollment: 26
Study Start Date: March 2010
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rye porrige breakfast Other: dietary intervention (rye porridge or wheat bread)
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 Other: dietary intervention (rye porridge or wheat bread)
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.

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.
  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01117363

Locations
Sweden
Good Food Practice
Uppsala, Sweden, 75183
Sponsors and Collaborators
Swedish University of Agricultural Sciences
Lantmannen Research and Development
Good Food Practice, Sweden
Investigators
Study Director: Per Åman, Professor Swedish University of Agricultural Sciences
  More Information

No publications provided by Swedish University of Agricultural Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hanna Isaksson, Swedish University of Agricultural Sciences
ClinicalTrials.gov Identifier: NCT01117363     History of Changes
Other Study ID Numbers: SIV829
Study First Received: May 4, 2010
Last Updated: May 4, 2010
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Swedish University of Agricultural Sciences:
Appetite whole grain

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014