Energy IntakeSUPPRESSNCT04788069
Effect of Sourdough Breads Consumption on Postprandial Responses, Satiety and Food Intake at Subsequent Meal
A study testing Wholemeal bread, Sourdough bread and Bread with sourdough in people with Energy Intake and Appetite Regulation, run by KU Leuven at 1 site in Belgium.
Trial summary
During this project the effect of different types of sourdough breads consumption on satiety, energy intake at subsequent meal and postprandial metabolic responses, will be investigated. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Energy Intake, Appetite Regulation
- What is being tested?
- Wholemeal bread, Sourdough bread and Bread with sourdough
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jun 2021to 5 Feb 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 18.5 - 25.0 kg/m2 at screening visit
- Regular eating pattern (3 meals per day on at least 5 days per week)
- Willingness to consume bread (180 g) on a daily base
- Stable body weight for the last 6 months
Who cannot join
- Currently smoking (has smoked in the last 28 days) or willingness to smoke during the study period
- Pregnancy, lactation or wish to become pregnant during the study period
- Family history of diabetes
- Previous or current gastrointestinal or endocrine disorders
- Previous or current substance/alcohol dependence or abuse (> 2 units per day/14 units per week)
- Intake of prescription medication
Show all 10Show fewer
- Coeliac disease or gluten sensitivity
- Use of pre- or probiotics within one month preceding the study
- Use of antibiotics within 3 months preceding the study
- 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.
About this study
During this project the effect of different types of sourdough breads consumption on satiety, energy intake at subsequent meal and postprandial metabolic responses, will be investigated.
Read the detailed description
A 3-phase randomised cross-over trial will be applied consisting of 3 intervention periods of 2 weeks, with a test day performed at the last day of each intervention period. During each intervention period, participants will consume a fixed amount of test bread, replacing their regular bread, and they will keep food and stool diaries preceding each Test-day. Faecal samples will be collected before each Test-day. On the Test-day, participants will perform a gastric emptying breath test. Furthermore, blood samples and appetite ratings will be collected at regular time points after consumption of the test bread for measurement of glucose, insulin, gut peptides, short-chain fatty acids (SCFA) and blood lipids. Food intake will be assessed by offering the subjects a standard lunch to be consumed ad-libitum.
- Conditions
- Energy Intake, Appetite Regulation
- Being tested
- Wholemeal bread, Sourdough bread, Bread with sourdough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wholemeal breadDietary supplement
180g wholemeal bread/day + fixed portion at test day
Sourdough breadDietary supplement
180g sourdough bread/day + fixed portion at test day
Bread with sourdoughDietary supplement
180g bread with sourdough/day + fixed portion at test day
| Study group | Role | What they receive |
|---|---|---|
| Wholemeal bread | Active comparator | Treatment with wholemeal bread Receives: Dietary Supplement: Wholemeal bread |
| Sourdough bread | Active comparator | Treatment with sourdough bread Receives: Dietary Supplement: Sourdough bread |
| Bread with sourdough | Active comparator | Treatment with bread with sourdough Receives: Dietary Supplement: Bread with sourdough |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appetite measurements
Appetite in response to test meal, will be measured using 100 millimeter (mm) Visual Analogue Scales (VAS) before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240 minutes).
Measured: During test day 1 (up to 4 hours)
Appetite measurements
Appetite in response to test meal, will be measured using 100 millimeter (mm) Visual Analogue Scales (VAS) before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240 minutes).
Measured: During test day 2 (up to 4 hours)
Appetite measurements
Appetite in response to test meal, will be measured using 100 millimeter (mm) Visual Analogue Scales (VAS) before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240 minutes).
Measured: During test day 3 (up to 4 hours)
Food intake at subsequent meal
Weighted amounts of ad-libitum food offered minus the weighted leftovers
Measured: During test day 1 (240 minutes after ingestion of breakfast)
Food intake at subsequent meal
Weighted amounts of ad-libitum food offered minus the weighted leftovers
Measured: During test day 2 (240 minutes after ingestion of breakfast)
Food intake at subsequent meal
Weighted amounts of ad-libitum food offered minus the weighted leftovers
Measured: During test day 3 (240 minutes after ingestion of breakfast)
Secondary outcomes (25)
Oral processing behaviour
Participants will be video-recorded to measure oral processing behaviour of the test meal
Measured: During test day 1 (up to 15 minutes)
Oral processing behaviour
Participants will be video-recorded to measure oral processing behaviour of the test meal
Measured: During test day 2 (up to 15 minutes)
Oral processing behaviour
Participants will be video-recorded to measure oral processing behaviour of the test meal
Measured: During test day 3 (up to 15 minutes)
Blood lipids
Plasma total cholesterol, triglycerides, LDL and HDL cholesterol, colourimetrically
Measured: During test day 1
Blood lipids
Plasma total cholesterol, triglycerides, LDL and HDL cholesterol, colourimetrically
Measured: During test day 2
Blood lipids
Plasma total cholesterol, triglycerides, LDL and HDL cholesterol, colourimetrically
Measured: During test day 3
Glucose response
Blood glucose response will be measured through blood samples collected via placed catheter before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 30, 60, 90, 120, 150, 180, 210, 240 minutes)
Measured: During test day 1 (up to 4 hours)
Glucose response
Blood glucose response will be measured through blood samples collected via placed catheter before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 30, 60, 90, 120, 150, 180, 210, 240 minutes)
Measured: During test day 2 (up to 4 hours)
Glucose response
Blood glucose response will be measured through blood samples collected via placed catheter before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 30, 60, 90, 120, 150, 180, 210, 240 minutes)
Measured: During test day 3 (up to 4 hours)
Insulin response
Blood C-peptide (as indicator of insulin response) will be measured through blood samples collected via placed catheter before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 30, 60, 90, 120, 150, 180, 210, 240 minutes).
Measured: During test day 1 (up to 4 hours)
Insulin response
Blood C-peptide (as indicator of insulin response) will be measured through blood samples collected via placed catheter before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 30, 60, 90, 120, 150, 180, 210, 240 minutes).
Measured: During test day 2 (up to 4 hours)
Insulin response
Blood C-peptide (as indicator of insulin response) will be measured through blood samples collected via placed catheter before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 30, 60, 90, 120, 150, 180, 210, 240 minutes).
Measured: During test day 3 (up to 4 hours)
Incretin hormones
Incretin hormones (GLP-1 and PYY) will be measured through blood samples collected via placed catheter before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 30, 60, 90, 120, 150, 180, 210, 240 minutes).
Measured: During test day 1 (up to 4 hours)
Incretin hormones
Incretin hormones (GLP-1 and PYY) will be measured through blood samples collected via placed catheter before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 30, 60, 90, 120, 150, 180, 210, 240 minutes).
Measured: During test day 2 (up to 4 hours)
Incretin hormones
Incretin hormones (GLP-1 and PYY) will be measured through blood samples collected via placed catheter before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 30, 60, 90, 120, 150, 180, 210, 240 minutes).
Measured: During test day 3 (up to 4 hours)
Short-chain-fatty-acids
Short-chain-fatty-acids will be measured through blood samples collected via placed catheter before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 390, 420, 450, 480 minutes).
Measured: During test day 1 (up to 8 hours)
Short-chain-fatty-acids
Short-chain-fatty-acids will be measured through blood samples collected via placed catheter before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 390, 420, 450, 480 minutes).
Measured: During test day 2 (up to 8 hours)
Short-chain-fatty-acids
Short-chain-fatty-acids will be measured through blood samples collected via placed catheter before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 390, 420, 450, 480 minutes).
Measured: During test day 3 (up to 8 hours)
Short-chain-fatty-acids
Faecal (GC-FID)
Measured: 1 time after intervention with each bread type (totally 3 times over a period of 10 weeks)
Gastric emptying rate
Gastric emptying rate will be measured through 13C-octanoic acid breath samples collected before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240 minutes).
Measured: During test day 1 (up to 4 hours)
Gastric emptying rate
Gastric emptying rate will be measured through 13C-octanoic acid breath samples collected before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240 minutes).
Measured: During test day 2 (up to 4 hours)
Gastric emptying rate
Gastric emptying rate will be measured through 13C-octanoic acid breath samples collected before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240 minutes).
Measured: During test day 3 (up to 4 hours)
Free-living energy intake
4-day food diaries, mobile app
Measured: 4 days during intervention with each bread type (totally 3x4 days over a period of 10 weeks)
Stool shape and consistency
4-day stool diaries, the Bristol Stool Score
Measured: 4 days during intervention with each bread type (totally 3x4 days over a period of 10 weeks)
Change in Gut microbiota composition
Change in Gut microbiota composition after consumption of each test meal for 14 days will be analysed using the relative abundance of bacterial taxa according to 16S rRNA sequencing data
Measured: 1 time after intervention with each bread type (totally 3 times over a period of 10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start1 Jun 2021
- Primary completion5 Feb 2024
- Study completion5 Feb 2024
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 Energy IntakeStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristin Verbeke, KU Leuven
- Investigators
- Kristin Verbeke, Prof., Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04788069
- Sponsor's protocol ID
- S64824
- Acronym
- SUPPRESS
- Status last verified
- May 2024
- First submitted
- 24 Feb 2021
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chatonidi G, Rosseel R, Dalile B, Satriawan D, Vandermeulen G, Van Holm B, Comer L, Maes P, Everaert N, Courtin CM, Verbeke K. Effect of whole meal yeast-leavened, sourdough-leavened and yeast-sourdough-leavened bread consumption on appetite, energy intake, and postprandial metabolic responses: A randomized, blinded, cross-over study. Appetite. 2026 Jan 1;216:108256. doi: 10.1016/j.appet.2025.108256. Epub 2025 Aug 5.
PubMed 40774378
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sourdough Breads Consumption on Postprandial Responses, Satiety and Food Intake at Subsequent Meal
- ClinicalTrials.gov ID
- NCT04788069
- Acronym / sponsor ID
- SUPPRESS / S64824
- Conditions
- Energy Intake, Appetite Regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 5 Feb 2024 (actual)
- Study completion
- 5 Feb 2024 (actual)
- First posted
- 9 Mar 2021 (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.
During this project the effect of different types of sourdough breads consumption on satiety, energy intake at subsequent meal and postprandial metabolic responses, will be investigated.
Detailed description
A 3-phase randomised cross-over trial will be applied consisting of 3 intervention periods of 2 weeks, with a test day performed at the last day of each intervention period. During each intervention period, participants will consume a fixed amount of test bread, replacing their regular bread, and they will keep food and stool diaries preceding each Test-day. Faecal samples will be collected before each Test-day. On the Test-day, participants will perform a gastric emptying breath test. Furthermore, blood samples and appetite ratings will be collected at regular time points after consumption of the test bread for measurement of glucose, insulin, gut peptides, short-chain fatty acids (SCFA) and blood lipids. Food intake will be assessed by offering the subjects a standard lunch to be consumed ad-libitum.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Wholemeal bread | Active comparator | Dietary Supplement: Wholemeal breadTreatment with wholemeal bread |
| Sourdough bread | Active comparator | Dietary Supplement: Sourdough breadTreatment with sourdough bread |
| Bread with sourdough | Active comparator | Dietary Supplement: Bread with sourdoughTreatment with bread with sourdough |
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 18.5 - 25.0 kg/m2 at screening visit
- Regular eating pattern (3 meals per day on at least 5 days per week)
- Willingness to consume bread (180 g) on a daily base
Key exclusion criteria (10 listed)
- Currently smoking (has smoked in the last 28 days) or willingness to smoke during the study period
- Pregnancy, lactation or wish to become pregnant during the study period
- Family history of diabetes
- Previous or current gastrointestinal or endocrine disorders
- Previous or current substance/alcohol dependence or abuse (> 2 units per day/14 units per week)
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 |
|---|---|---|
| Wholemeal bread180g wholemeal bread/day + fixed portion at test day | Dietary supplement | Wholemeal bread |
| Sourdough bread180g sourdough bread/day + fixed portion at test day | Dietary supplement | Sourdough bread |
| Bread with sourdough180g bread with sourdough/day + fixed portion at test day | Dietary supplement | Bread with sourdough |
Primary outcome
Appetite measurements
Time frame: During test day 1 (up to 4 hours)
Appetite in response to test meal, will be measured using 100 millimeter (mm) Visual Analogue Scales (VAS) before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240 minutes).
Appetite measurements
Time frame: During test day 2 (up to 4 hours)
Appetite in response to test meal, will be measured using 100 millimeter (mm) Visual Analogue Scales (VAS) before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240 minutes).
Appetite measurements
Time frame: During test day 3 (up to 4 hours)
Appetite in response to test meal, will be measured using 100 millimeter (mm) Visual Analogue Scales (VAS) before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240 minutes).
Food intake at subsequent meal
Time frame: During test day 1 (240 minutes after ingestion of breakfast)
Weighted amounts of ad-libitum food offered minus the weighted leftovers
Food intake at subsequent meal
Time frame: During test day 2 (240 minutes after ingestion of breakfast)
Weighted amounts of ad-libitum food offered minus the weighted leftovers
Food intake at subsequent meal
Time frame: During test day 3 (240 minutes after ingestion of breakfast)
Weighted amounts of ad-libitum food offered minus the weighted leftovers
25 secondary outcomes
Oral processing behaviour
Time frame: During test day 1 (up to 15 minutes)
Oral processing behaviour
Time frame: During test day 2 (up to 15 minutes)
Oral processing behaviour
Time frame: During test day 3 (up to 15 minutes)
Blood lipids
Time frame: During test day 1
Blood lipids
Time frame: During test day 2
Blood lipids
Time frame: During test day 3
Glucose response
Time frame: During test day 1 (up to 4 hours)
Glucose response
Time frame: During test day 2 (up to 4 hours)
Glucose response
Time frame: During test day 3 (up to 4 hours)
Insulin response
Time frame: During test day 1 (up to 4 hours)
Insulin response
Time frame: During test day 2 (up to 4 hours)
Insulin response
Time frame: During test day 3 (up to 4 hours)
Incretin hormones
Time frame: During test day 1 (up to 4 hours)
Incretin hormones
Time frame: During test day 2 (up to 4 hours)
Incretin hormones
Time frame: During test day 3 (up to 4 hours)
Short-chain-fatty-acids
Time frame: During test day 1 (up to 8 hours)
Short-chain-fatty-acids
Time frame: During test day 2 (up to 8 hours)
Short-chain-fatty-acids
Time frame: During test day 3 (up to 8 hours)
Short-chain-fatty-acids
Time frame: 1 time after intervention with each bread type (totally 3 times over a period of 10 weeks)
Gastric emptying rate
Time frame: During test day 1 (up to 4 hours)
Gastric emptying rate
Time frame: During test day 2 (up to 4 hours)
Gastric emptying rate
Time frame: During test day 3 (up to 4 hours)
Free-living energy intake
Time frame: 4 days during intervention with each bread type (totally 3x4 days over a period of 10 weeks)
Stool shape and consistency
Time frame: 4 days during intervention with each bread type (totally 3x4 days over a period of 10 weeks)
Change in Gut microbiota composition
Time frame: 1 time after intervention with each bread type (totally 3 times over a period of 10 weeks)
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 May 2024.
- Derived from this study: PubMed 40774378Chatonidi G, Rosseel R, Dalile B, Satriawan D, Vandermeulen G, Van Holm B, Comer L, Maes P, Everaert N, Courtin CM, Verbeke K. Effect of whole meal yeast-leavened, sourdough-leavened and yeast-sourdough-leavened bread consumption on appetite, energy intake, and postprandial metabolic responses: A randomized, blinded, cross-over study. Appetite. 2026 Jan 1;216:108256. doi: 10.1016/j.appet.2025.108256. Epub 2025 Aug 5.
- Individual participant dataSharing planned: No
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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, Prof. 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 Wholemeal bread, Sourdough bread and Bread with sourdough in people with Energy Intake and Appetite Regulation, 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 10 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 May 2024. 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. 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?
Appetite measurements (time frame: During test day 1 (up to 4 hours)). The study lists 6 primary outcomes in all. 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 NCT04788069, 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 May 2024.