Obesity PreventionNCT01117363
Effect of Three Weeks Consumption of Rye Porridge Breakfast
A study testing dietary intervention (rye porridge or wheat bread) in people with Obesity Prevention, run by Swedish University of Agricultural Sciences at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity Prevention
- What is being tested?
- dietary intervention (rye porridge or wheat bread)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2010to Jul 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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:
- 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.
- on day 8 during each intervention period, orocecal transit time and breath hydrogen will be measured after intake of the breakfast.
- 3 day weighed food diaries will be taken at three occasions: at baseline and during the second week of each dietary intervention period.
- Conditions
- Obesity Prevention
- Being tested
- dietary intervention (rye porridge or wheat bread)
- Keywords
- Appetite whole grain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary intervention (rye porridge or wheat bread)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Rye porrige breakfast | Experimental | Not described Receives: Other: dietary intervention (rye porridge or wheat bread) |
| Refined wheat reference bread breakfast | Active comparator | Not described Receives: Other: dietary intervention (rye porridge or wheat bread) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appetite profile
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.
Measured: 24 h
Secondary outcomes (3)
energy intake
Weighed food records was completed by the subjects during baseline and each intervention phase.
Measured: 3 days
Orocecal transit time
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.
Measured: 8 h
Breath hydrogen
Measured: 8 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2010 (estimated)
- Study startMar 2010
- Primary completionJul 2010 (estimated)
- Study completionJul 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swedish University of Agricultural Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Lantmannen Research and Development, Good Food Practice, Sweden
- Investigators
- Per Åman, Professor, Study director, Swedish University of Agricultural Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01117363
- Sponsor's protocol ID
- SIV829
- Status last verified
- May 2010
- First submitted
- 4 May 2010
- Last updated
- 5 May 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Isaksson H, Tillander I, Andersson R, Olsson J, Fredriksson H, Webb DL, Aman P. Whole grain rye breakfast - sustained satiety during three weeks of regular consumption. Physiol Behav. 2012 Feb 1;105(3):877-84. doi: 10.1016/j.physbeh.2011.10.023. Epub 2011 Oct 28.
PubMed 22061429
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Three Weeks Consumption of Rye Porridge Breakfast on 24 h Appetite Profile, and Acute Effect on OCTT and Breath Hydrogen
- ClinicalTrials.gov ID
- NCT01117363
- Acronym / sponsor ID
- SIV829
- Conditions
- Obesity Prevention
- Keywords
- Appetite whole grain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Swedish University of Agricultural SciencesUniversity, hospital or other
- Collaborators
- Lantmannen Research and Development, Good Food Practice, Sweden
- Study start
- Mar 2010
- Primary completion
- Jul 2010 (estimated)
- Study completion
- Jul 2010 (estimated)
- First posted
- 5 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- on day 8 during each intervention period, orocecal transit time and breath hydrogen will be measured after intake of the breakfast.
- 3 day weighed food diaries will be taken at three occasions: at baseline and during the second week of each dietary intervention period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rye porrige breakfast | Experimental | Other: dietary intervention (rye porridge or wheat bread) |
| Refined wheat reference bread breakfast | Active comparator | Other: dietary intervention (rye porridge or wheat bread) |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Refined wheat reference bread breakfast, Rye porrige breakfast |
Primary outcome
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.
3 secondary outcomes
energy intake
Time frame: 3 days
Orocecal transit time
Time frame: 8 h
Breath hydrogen
Time frame: 8 h
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2010.
- Derived from this study: PubMed 22061429Isaksson H, Tillander I, Andersson R, Olsson J, Fredriksson H, Webb DL, Aman P. Whole grain rye breakfast - sustained satiety during three weeks of regular consumption. Physiol Behav. 2012 Feb 1;105(3):877-84. doi: 10.1016/j.physbeh.2011.10.023. Epub 2011 Oct 28.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per Åman, Professor study director
Swedish University of Agricultural Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dietary intervention (rye porridge or wheat bread) in people with Obesity Prevention, run by Swedish University of Agricultural Sciences at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appetite profile (time frame: 24 h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01117363, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2010.