ObesityNCT00876785
Effect of Rye Bread Breakfasts on Eight Hour Satiety Ratings
A study testing Rye bread breakfast and wheat bread based breakfast in people with Obesity, run by Swedish University of Agricultural Sciences at 1 site in Sweden.
Trial summary
The aim of the present study was to investigate subjective appetite during 8 hours after intake of iso-caloric rye bread breakfasts varying in dietary fiber composition and content. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Rye bread breakfast and wheat bread based breakfast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2007to May 2008
- 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
- age between 20 and 60 years
- body mass index (BMI) 18-27 kg/m2
- a habit of consuming breakfast, lunch and dinner everyday
- fasting plasma glucose 4.0-6.1 mmol/L
- haemoglobin (Hb) in men 130-170 g/L, in women 120-150 g/L
- thyroid-stimulating hormone (TSH) 0.3-4.0 mlE/L
- 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 of more than 10% three months prior to screening
- consumption of any restricted diet such as vegan, gluten-free, slimming etc.
- pregnancy, lactation or wish to become pregnant during the study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Rye Bread Breakfasts on Subjective Hunger and Satiety
The aim of the present study was to investigate subjective appetite during 8 hours after intake of iso-caloric rye bread breakfasts varying in dietary fiber composition and content.
Read the detailed description
Energy-dense foods that require little effort to consume and that are rapidly digested may cause passive over-consumption by failure to provide a feeling of fullness corresponding to the energy content. A diet that is predominantly based on such foods may lead to overweight. It is therefore important to identify properties of foods that facilitate energy balance by creating a high satiety per calorie. A number of studies have confirmed that foods naturally rich in dietary fiber promote the feeling of fullness and reduce hunger in the short term.
- Conditions
- Obesity
- Being tested
- Rye bread breakfast, wheat bread based breakfast
- Keywords
- Rye bread satiety breakfast
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rye bread breakfastOther
A randomised, within-subject comparison design was used. Appetite (hunger, satiety and desire to eat) was rated regularly from just before breakfast at 08:00 until 16:00. Amount, type and timing of food and drink intake during the study period were standardised.
wheat bread based breakfastOther
Reference wheat bread breakfast
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Reference wheat bread breakfast Receives: Other: wheat bread based breakfast |
| 2 | Experimental | Rye bread breakfast Receives: Other: Rye bread breakfast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective satiety, hunger and desire to eat
Measured: During 8 hours after intake of test meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2009 (estimated)
- Study startSep 2007
- Primary completionMar 2008
- Study completionMay 2008
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 ObesityStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swedish University of Agricultural Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Lantmännen R&D, Good Food Practice, Sweden
- Investigators
- Per Aman, Professor, Study director, university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00876785
- Sponsor's protocol ID
- SI829
- Status last verified
- Apr 2009
- First submitted
- 6 Apr 2009
- Last updated
- 14 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Isaksson H, Fredriksson H, Andersson R, Olsson J, Aman P. Effect of rye bread breakfasts on subjective hunger and satiety: a randomized controlled trial. Nutr J. 2009 Aug 26;8:39. doi: 10.1186/1475-2891-8-39.
PubMed 19709412
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Rye Bread Breakfasts on Subjective Hunger and Satiety
- ClinicalTrials.gov ID
- NCT00876785
- Acronym / sponsor ID
- SI829
- Conditions
- Obesity
- Keywords
- Rye bread satiety breakfast
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Swedish University of Agricultural SciencesUniversity, hospital or other
- Collaborators
- Lantmännen R&D, Good Food Practice, Sweden
- Study start
- Sep 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 7 Apr 2009 (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.
The aim of the present study was to investigate subjective appetite during 8 hours after intake of iso-caloric rye bread breakfasts varying in dietary fiber composition and content.
Detailed description
Energy-dense foods that require little effort to consume and that are rapidly digested may cause passive over-consumption by failure to provide a feeling of fullness corresponding to the energy content. A diet that is predominantly based on such foods may lead to overweight. It is therefore important to identify properties of foods that facilitate energy balance by creating a high satiety per calorie. A number of studies have confirmed that foods naturally rich in dietary fiber promote the feeling of fullness and reduce hunger in the short term.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: wheat bread based breakfastReference wheat bread breakfast |
| 2 | Experimental | Other: Rye bread breakfastRye bread breakfast |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- age between 20 and 60 years
- body mass index (BMI) 18-27 kg/m2
- a habit of consuming breakfast, lunch and dinner everyday
- fasting plasma glucose 4.0-6.1 mmol/L
- haemoglobin (Hb) in men 130-170 g/L, in women 120-150 g/L
Key exclusion criteria (8 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 |
|---|---|---|
| Rye bread breakfastA randomised, within-subject comparison design was used. Appetite (hunger, satiety and desire to eat) was rated regularly from just before breakfast at 08:00 until 16:00. Amount, type and timing of food and drink intake during the study period were standardised. | Other | 2 |
| wheat bread based breakfastReference wheat bread breakfast | Other | 1 |
Primary outcome
Subjective satiety, hunger and desire to eat
Time frame: During 8 hours after intake of test meal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2009.
- Derived from this study: PubMed 19709412Isaksson H, Fredriksson H, Andersson R, Olsson J, Aman P. Effect of rye bread breakfasts on subjective hunger and satiety: a randomized controlled trial. Nutr J. 2009 Aug 26;8:39. doi: 10.1186/1475-2891-8-39.
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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 Aman, Professor study director
university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rye bread breakfast and wheat bread based breakfast in people with Obesity, 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 7 inclusion and 8 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: finished, as of the sponsor's last update on 14 Apr 2009. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Subjective satiety, hunger and desire to eat (time frame: During 8 hours after intake of test meal). 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 NCT00876785, 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 14 Apr 2009.