Appetite RegulationSOBERNCT05590611
Impact of Sourdough Bread Consumption on Long-term Energy Intake: A Pilot Study of Feasibility
A study testing Dietary Intervention with Brown Bread and Dietary Intervention with Sourdough Bread in people with Appetite Regulation and Energy Intake, run by KU Leuven at 1 site in Belgium.
Trial summary
The present study is a pilot study examining whether long-term sourdough bread consumption reduces energy intake and blood lipids levels over a period of 4 weeks in free-living normalweight and overweight participants. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Appetite Regulation, Energy Intake, Body Weight Changes
- What is being tested?
- Dietary Intervention with Brown Bread and Dietary Intervention with Sourdough Bread
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Dec 2022to Sep 2024
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female and male participants
- Age range 18 - 50
- BMI range >20 kg/m2 at screening visit
- Regular eating pattern (3 meals per day on at least 5 days per week)
- Habitual brown bread consumption of at least 1 slice per day (assessed by The European Prospective Investigation into Cancer (EPIC) Norfolk FFQ)
- Stable body weight for the last 6 months
Who cannot join
- Currently smoking or willingness to smoke during the study period
- Pregnancy, lactation or wish to become pregnant during the study period
- Previous or current gastrointestinal or endocrine disorders
- Previous or current substance/alcohol dependence or abuse (> 2 units per day/14 units per week)
- Coeliac disease or gluten sensitivity
- Allergy/intolerance to milk, egg, nuts, soy or sesame
- Habitual sourdough bread consumption of at least 1 slice per day (assessed by The European Prospective Investigation into Cancer (EPIC) Norfolk FFQ)
- Excessive concern about eating habits or body weight as evidenced from scores < 18 on the restraint and disinhibition subscales of the Three-Factor Eating Questionnaire (Stunkard \& Messick, 1985)
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
KU Leuven
Leuven, Vlaams Brabant, 3000
Georgia Chatonidi, +32 16 19 43 24, georgia.chatonidi@kuleuven.be
Kristin Verbeke, +32 16 33 01 50, kristin.verbeke@kuleuven.be
About this study
Official title: Impact of Sourdough Bread Consumption on Long-term Energy Intake: A Pilot Study of Feasibility (SOBER)
The present study is a pilot study examining whether long-term sourdough bread consumption reduces energy intake and blood lipids levels over a period of 4 weeks in free-living normalweight and overweight participants.
- Conditions
- Appetite Regulation, Energy Intake, Body Weight Changes, Eating Behavior, Overweight and Obesity
- Being tested
- Dietary Intervention with Brown Bread, Dietary Intervention with Sourdough Bread
- Medical subject headings
- Body Weight Changes, Feeding Behavior, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Intervention with Brown BreadOther
The participants in this group will be asked to replace all their habitual bread intake by standard brown bread. The duration of the study for each participant is 4 weeks. Apart from the change in type of bread, participants will maintain their habitual diet.
Dietary Intervention with Sourdough BreadOther
The participants in thisgroup will be asked to replace all their habitual bread intake by wholemeal sourdough bread. The duration of the study for each participant is 4 weeks. Apart from the change in type of bread, participants will maintain their habitual diet.
| Study group | Role | What they receive |
|---|---|---|
| Brown Bread | Placebo comparator | Not described Receives: Other: Dietary Intervention with Brown Bread |
| Wholemeal Sourdough Bread | Active comparator | Not described Receives: Other: Dietary Intervention with Sourdough Bread |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy intake (kilocalories)
Assessed via 4-day food diaries using a mobile app
Measured: 4 weeks
Secondary outcomes (2)
Body weight
Measured: 4 weeks
Blood lipid levels
Plasma total cholesterol, triglycerides, LDL and HDL cholesterol, colourimetrically
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start1 Dec 2022
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appetite RegulationStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristin Verbeke, KU Leuven
- Investigators
- Kristin Verbeke, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05590611
- Sponsor's protocol ID
- S66499
- Acronym
- SOBER
- Status last verified
- Jun 2023
- First submitted
- 17 Oct 2022
- Last updated
- 5 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Sourdough Bread Consumption on Long-term Energy Intake: A Pilot Study of Feasibility (SOBER)
- ClinicalTrials.gov ID
- NCT05590611
- Acronym / sponsor ID
- SOBER / S66499
- Conditions
- Appetite Regulation, Energy Intake, Body Weight Changes, Eating Behavior, Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 21 Oct 2022 (actual)
- 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 present study is a pilot study examining whether long-term sourdough bread consumption reduces energy intake and blood lipids levels over a period of 4 weeks in free-living normalweight and overweight participants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brown Bread | Placebo comparator | Other: Dietary Intervention with Brown Bread |
| Wholemeal Sourdough Bread | Active comparator | Other: Dietary Intervention with Sourdough Bread |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Female and male participants
- Age range 18 - 50
- BMI range >20 kg/m2 at screening visit
- Regular eating pattern (3 meals per day on at least 5 days per week)
- Habitual brown bread consumption of at least 1 slice per day (assessed by The European Prospective Investigation into Cancer (EPIC) Norfolk FFQ)
Key exclusion criteria (8 listed)
- Currently smoking or willingness to smoke during the study period
- Pregnancy, lactation or wish to become pregnant during the study period
- Previous or current gastrointestinal or endocrine disorders
- Previous or current substance/alcohol dependence or abuse (> 2 units per day/14 units per week)
- Coeliac disease or gluten sensitivity
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 with Brown BreadThe participants in this group will be asked to replace all their habitual bread intake by standard brown bread. The duration of the study for each participant is 4 weeks. Apart from the change in type of bread, participants will maintain their habitual diet. | Other | Brown Bread |
| Dietary Intervention with Sourdough BreadThe participants in thisgroup will be asked to replace all their habitual bread intake by wholemeal sourdough bread. The duration of the study for each participant is 4 weeks. Apart from the change in type of bread, participants will maintain their habitual diet. | Other | Wholemeal Sourdough Bread |
Primary outcome
Energy intake (kilocalories)
Time frame: 4 weeks
Assessed via 4-day food diaries using a mobile app
2 secondary outcomes
Body weight
Time frame: 4 weeks
Blood lipid levels
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
- Individual participant dataSharing planned: No. No IPD will be shared with other researchers.
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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.
Kristin Verbeke principal investigator
KU Leuven
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 with Brown Bread and Dietary Intervention with Sourdough Bread in people with Appetite Regulation and Energy Intake, run by KU Leuven at 1 site in Belgium.
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 6 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: status not confirmed, as of the sponsor's last update on 5 Jun 2023. 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 Belgium. 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. Some participants in this study may receive a placebo. 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?
Contact Georgia Chatonidi (+3216194324, georgia.chatonidi@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy intake (kilocalories) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2023.