AppetiteSPARNCT06015867
Effect of Sourdough Bread Consumption on Postprandial Responses, Appetite Regulation and Energy Intake
A study testing Dietary Intervention with Wholemeal Bread with Yeast and Dietary Intervention with Wholemeal Sourdough Bread in people with Appetite and Satiety, run by KU Leuven at 2 sites in Belgium.
Trial summary
During this project the effect of yeast bread and 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
- Appetite, Satiety, Energy Intake
- What is being tested?
- Dietary Intervention with Wholemeal Bread with Yeast and Dietary Intervention with Wholemeal Sourdough Bread
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 2 sitesBelgium
- Study dates
- 1 Jan 2024to 28 Apr 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)
- 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)
- Coeliac disease or gluten sensitivity
Show all 9Show fewer
- 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
2 sites in 1 country.
Belgium2 sites
KU Leuven/UZ Leuven
Leuven, Vlaams Brabant, 3000
UZ Leuven
Leuven, 3000
About this study
Official title: Effect of Sourdough Bread Consumption on Postprandial Responses, Appetite Regulation and Energy Intake at the Subsequent Meal (SPAR Study)
During this project the effect of yeast bread and sourdough breads consumption on satiety, energy intake at subsequent meal and postprandial metabolic responses, will be investigated.
Read the detailed description
The primary aim of this study will be to evaluate the impact of an alternative starter culture that produces high levels of lactic acid on appetite regulation (subjective satiety and energy intake at the subsequent meal). The second aim will be to identify mechanistic parameters that may explain the observed effects, including glycaemic and insulin response, and gastric emptying rate. In addition, habitual physical activity levels, and mood and stress levels of the subjects will be evaluated as potential covariates of appetite regulation.
It is hypothesized that:
Sourdough breads fermented with the alternative starter culture that produce high concentrations of lactic acid will reduce glucose response via lower starch digestibility and/or slower gastric emptying rate. The reduced glycaemic response will lead to higher satiety and lower energy intake at the subsequent meal (more than 10%).
- Conditions
- Appetite, Satiety, Energy Intake, Glucose Response, Insulin Response, Gastric Emptying
- Being tested
- Dietary Intervention with Wholemeal Bread with Yeast, Dietary Intervention with Wholemeal Sourdough Bread
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Intervention with Wholemeal Bread with YeastDietary supplement
Single administration of 150g wholemeal long-time processed bread with baker's yeast, with no lactic acid (control).
Dietary Intervention with Wholemeal Sourdough BreadDietary supplement
Single administration of 150g wholemeal long-time processed sourdough bread (with alternative lactic acid bacteria and yeast) high in lactic acid concentration.
| Study group | Role | What they receive |
|---|---|---|
| Control Bread: Wholemeal Yeast Bread | Active comparator | Wholemeal bread, containing mainly of wholemeal flour, water and bakers' yeast will be used as the control test bread. Receives: Dietary Supplement: Dietary Intervention with Wholemeal Bread with Yeast; Dietary Supplement: Dietary Intervention with Wholemeal Sourdough Bread |
| Wholemeal Sourdough Bread | Active comparator | Wholemeal sourdough bread, containing mainly of wholemeal flour, water and added sourdough co-culture (consisting of W.anom.+ C.crust strain). Receives: Dietary Supplement: Dietary Intervention with Wholemeal Bread with Yeast; Dietary Supplement: Dietary Intervention with Wholemeal Sourdough Bread |
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), with 0 being the minimum value (not at all) and 100 being the maximum value (extremely).
Measurements will be taken: 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), with 0 being the minimum value (not at all) and 100 being the maximum value (extremely).
Measurements will be taken: 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)
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)
Secondary outcomes (16)
Glucose response
Blood glucose response will be measured through blood samples collected via placed catheter before eating and at respective time points after completion of test meal (I.e. 0, 15, 30, 45, 60, 75, 90, 105, 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 and at respective time points after completion of test meal (I.e. 0, 15, 30, 45, 60, 75, 90, 105, 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 and at respective time points after completion of test meal (I.e. 0, 15, 30, 45, 60, 75, 90, 105, 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 and at respective time points after completion of test meal (I.e. 0, 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, 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 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)
Subjective stress ratings
Subjective stress, will be measured using 100 millimeter (mm) Visual Analogue Scales (VAS), with with 0 being the minimum value (not at all) and 100 being the maximum value (extremely).
Measurements will be takem: before eating (i.e. -15 minute) and at respective time points after completion of test meal (I.e. 0, 60, 120, 180, 240 minutes).
Measured: During test day 1 (up to 4 hours)
Subjective stress ratings
Subjective stress, will be measured using 100 millimeter (mm) Visual Analogue Scales (VAS), with with 0 being the minimum value (not at all) and 100 being the maximum value (extremely).
Measurements will be takem: before eating (i.e. -15 minute) and at respective time points after completion of test meal (I.e. 0, 60, 120, 180, 240 minutes).
Measured: During test day 2 (up to 4 hours)
Physical activity questionnaire
Questionnaire about habitual physical activity over the past 1 week. Subjects will have to report how many days per week and for how many minus they perform vigorous, moderate or relaxed physical activity.
Measured: At the end of test day 1
Physical activity questionnaire
Questionnaire about habitual physical activity over the past 1 week. Subjects will have to report how many days per week and for how many minus they perform vigorous, moderate or relaxed physical activity.
Measured: At the end of test day 2
Mood related questionnaires - The Positive and Negative Affect Schedule (PANAS scale)
Mood related questionnaires over the past 1 week. Subjects will have to evaluate the extent they have felt certain feelings over the past week. Score will vary between 1 (Very slightly or not at all) to 5 (Extremely).
Measured: At the end of test day 1
Mood related questionnaires - The Positive and Negative Affect Schedule (PANAS scale)
Mood related questionnaires over the past 1 week. Subjects will have to evaluate the extent they have felt certain feelings over the past week. Score will vary between 1 (Very slightly or not at all) to 5 (Extremely).
Measured: At the end of test day 2
Mood related questionnaires - Perceived Stress Scale - 10 items (PSS-10)
Mood related questionnaires over the past 1 week. Subjects will have to evaluate how ofter have felt certain feelings over the past week. Score will vary between 0 (Never) to 4 (Very often).
Measured: At the end of test day 1
Mood related questionnaires - Perceived Stress Scale - 10 items (PSS-10)
Mood related questionnaires over the past 1 week. Subjects will have to evaluate how ofter have felt certain feelings over the past week. Score will vary between 0 (Never) to 4 (Very often).
Measured: At the end of test day 2
Mood related questionnaires - Depression, Anxiety, Stress Scales - 21 items (DASS-21)
Mood related questionnaires over the past 1 week. Subjects will have to evaluate es how much the statement applied to them over the last week. Score will vary between 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time).
Measured: At the end of test day 1
Mood related questionnaires - Depression, Anxiety, Stress Scales - 21 items (DASS-21)
Mood related questionnaires over the past 1 week. Subjects will have to evaluate es how much the statement applied to them over the last week. Score will vary between 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time).
Measured: At the end of test day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start1 Jan 2024
- Primary completion28 Apr 2024
- Study completion28 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AppetiteStudies 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 47 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, PhD, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06015867
- Sponsor's protocol ID
- S64824 - B3222020000339
- Acronym
- SPAR
- Status last verified
- May 2024
- First submitted
- 22 Aug 2023
- Last updated
- 14 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 Bread Consumption on Postprandial Responses, Appetite Regulation and Energy Intake at the Subsequent Meal (SPAR Study)
- ClinicalTrials.gov ID
- NCT06015867
- Acronym / sponsor ID
- SPAR / S64824 - B3222020000339
- Conditions
- Appetite, Satiety, Energy Intake, Glucose Response, Insulin Response, Gastric Emptying
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 28 Apr 2024 (actual)
- Study completion
- 28 Apr 2024 (actual)
- First posted
- 29 Aug 2023 (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 yeast bread and sourdough breads consumption on satiety, energy intake at subsequent meal and postprandial metabolic responses, will be investigated.
Detailed description
The primary aim of this study will be to evaluate the impact of an alternative starter culture that produces high levels of lactic acid on appetite regulation (subjective satiety and energy intake at the subsequent meal). The second aim will be to identify mechanistic parameters that may explain the observed effects, including glycaemic and insulin response, and gastric emptying rate. In addition, habitual physical activity levels, and mood and stress levels of the subjects will be evaluated as potential covariates of appetite regulation.
It is hypothesized that:
Sourdough breads fermented with the alternative starter culture that produce high concentrations of lactic acid will reduce glucose response via lower starch digestibility and/or slower gastric emptying rate. The reduced glycaemic response will lead to higher satiety and lower energy intake at the subsequent meal (more than 10%).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Bread: Wholemeal Yeast Bread | Active comparator | Dietary Supplement: Dietary Intervention with Wholemeal Bread with Yeast, Dietary Supplement: Dietary Intervention with Wholemeal Sourdough BreadWholemeal bread, containing mainly of wholemeal flour, water and bakers' yeast will be used as the control test bread. |
| Wholemeal Sourdough Bread | Active comparator | Dietary Supplement: Dietary Intervention with Wholemeal Bread with Yeast, Dietary Supplement: Dietary Intervention with Wholemeal Sourdough BreadWholemeal sourdough bread, containing mainly of wholemeal flour, water and added sourdough co-culture (consisting of W.anom.+ C.crust strain). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 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)
- Stable body weight for the last 6 months
Key exclusion criteria (9 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 |
|---|---|---|
| Dietary Intervention with Wholemeal Bread with YeastSingle administration of 150g wholemeal long-time processed bread with baker's yeast, with no lactic acid (control). | Dietary supplement | Control Bread: Wholemeal Yeast Bread, Wholemeal Sourdough Bread |
| Dietary Intervention with Wholemeal Sourdough BreadSingle administration of 150g wholemeal long-time processed sourdough bread (with alternative lactic acid bacteria and yeast) high in lactic acid concentration. | Dietary supplement | Control Bread: Wholemeal Yeast Bread, Wholemeal Sourdough Bread |
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), with 0 being the minimum value (not at all) and 100 being the maximum value (extremely). Measurements will be taken: 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), with 0 being the minimum value (not at all) and 100 being the maximum value (extremely). Measurements will be taken: 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
16 secondary outcomes
Glucose response
Time frame: During test day 1 (up to 4 hours)
Glucose response
Time frame: During test day 2 (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)
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)
Subjective stress ratings
Time frame: During test day 1 (up to 4 hours)
Subjective stress ratings
Time frame: During test day 2 (up to 4 hours)
Physical activity questionnaire
Time frame: At the end of test day 1
Physical activity questionnaire
Time frame: At the end of test day 2
Mood related questionnaires - The Positive and Negative Affect Schedule (PANAS scale)
Time frame: At the end of test day 1
Mood related questionnaires - The Positive and Negative Affect Schedule (PANAS scale)
Time frame: At the end of test day 2
Mood related questionnaires - Perceived Stress Scale - 10 items (PSS-10)
Time frame: At the end of test day 1
Mood related questionnaires - Perceived Stress Scale - 10 items (PSS-10)
Time frame: At the end of test day 2
Mood related questionnaires - Depression, Anxiety, Stress Scales - 21 items (DASS-21)
Time frame: At the end of test day 1
Mood related questionnaires - Depression, Anxiety, Stress Scales - 21 items (DASS-21)
Time frame: At the end of test day 2
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.
- 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, PhD principal investigator
KU Leuven
2 sites 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 Wholemeal Bread with Yeast and Dietary Intervention with Wholemeal Sourdough Bread in people with Appetite and Satiety, run by KU Leuven at 2 sites 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 5 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: 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 2 sites 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 4 primary outcomes in all. 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 14 May 2024.