DyspepsiaDigeribilitàNCT03207516
Sourdough Bakery Products and Digestive Function
A study testing Sourdough --> Brewer's Yeast and Brewer's Yeast --> Sourdough in people with Dyspepsia, run by Irccs Sdn.
Trial summary
In a double-blind, randomised crossover study, two sourdough croissants (SC) or two brewer's yeast croissants (BC) were served to 17 (9 F; Age range 18-40; BMI range 18-24 kg/m2) healthy subjects to evaluate the effects of their ingestion on postprandial gastrointestinal functions. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyspepsia
- What is being tested?
- Sourdough --> Brewer's Yeast and Brewer's Yeast --> Sourdough
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- 22 Jul 2014to 28 Apr 2015
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age ranging between 18 and 40 yrs
- normal-weight (body mass index 18-24.9 kg/m2),
Who cannot join
- smoke
- functional or organic gastrointestinal disease
- gluten allergy
- dyslipidemia
- diabetes
- psychiatric disorders
Show all 9Show fewer
- claustrophobia
- pregnancy
- breast-feeding
About this study
Official title: Impact of Bakery Products With Sourdough or Brewer's Yeast on Digestive Function: a Double Blind Randomised Study in Healthy Subjects
In a double-blind, randomised crossover study, two sourdough croissants (SC) or two brewer's yeast croissants (BC) were served to 17 (9 F; Age range 18-40; BMI range 18-24 kg/m2) healthy subjects to evaluate the effects of their ingestion on postprandial gastrointestinal functions. Hydrogen breath test was performed to measure H2 production after SC and BC ingestion. Gastric volume was evaluated by Magnetic Resonance(MR) Imaging to calculate gastric emptying rate in the 3-hour interval following croissant ingestion. Palatability and postprandial gastrointestinal symptoms and perceptions over a 4-h period after the meal were evaluated by visual analogue scale (VAS). In addition, in the 3-hour interval, blood samples were drawn to measure serum glucose levels. The area under the curve (AUC) was employed to evaluate global kinetics of all parameters and the T-test was used to evaluate differences between groups.
Read the detailed description
In this monocentric study, a double-blind, randomised crossover design was used, with washout periods of at least one week between study days. A standardized meal consisting of two 100 g croissants prepared with sourdough or with brewer's yeast was administered randomly to 17 (9 F; Age range 18-40; BMI range 18-24 kg/m2) healthy subjects after an overnight fast (at least 8 h) and consumed in a 10-minute interval with 300 mL of water. Immediately after meal ingestion, subjects were asked to evaluate croissant palatability. Gastric volume was evaluated by Magnetic Resonance(MR) Imaging to calculate gastric emptying rate in the 3-hour interval following croissant ingestion. Hydrogen breath test was performed to assess gastrointestinal fermentation measuring H2 production after SC and BC ingestion. Postprandial gastrointestinal symptoms and perceptions over a 4-h period after the meal were evaluated by visual analogue scale (VAS). In addition, in the 3-hour interval, blood samples were drawn to measure serum glucose levels. The protocol was repeated twice in each subject, once with sourdough croissants (SC) and once with brewer's yeast croissants (BC), dispensed according to a computer generated randomisation list created by RC following simple randomisation procedures (computerized random numbers). The area under the curve (AUC) was employed to evaluate global kinetics of all parameters and the T-test was used to evaluate differences between groups.
- Conditions
- Dyspepsia
- Being tested
- Sourdough --> Brewer's Yeast, Brewer's Yeast --> Sourdough
- Keywords
- sourdough; leavening process; fermentation; brewer's yeast
- Medical subject headings
- Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sourdough --> Brewer's YeastDietary supplement
Impact of bakery products with sourdough or brewer's yeast on digestive function
Brewer's Yeast --> SourdoughDietary supplement
Impact of bakery products with sourdough or brewer's yeast on digestive function
| Study group | Role | What they receive |
|---|---|---|
| Sourdough --> Brewer's Yeast | Active comparator | Sourdough --> Brewer's Yeast
1. administration of two 100 g croissants prepared with sourdough after an overnight fast.
2. Magnetic Resonance (MR) Imaging analysis of gastric emptying, evaluation of postprandial gastrointestinal fermentation, croissant palatability, gastrointestinal symptoms and perceptions, and serum glucose levels at several time points.
3. washout period: 7 days
4. administration of two 100 g croissants prepared with brewer's yeast after an overnight fast.
5. Magnetic Resonance (MR) Imaging analysis of gastric emptying, evaluation of postprandial gastrointestinal fermentation, croissant palatability, gastrointestinal symptoms and perceptions, and serum glucose levels at several time points. Receives: Dietary Supplement: Sourdough --> Brewer's Yeast; Dietary Supplement: Brewer's Yeast --> Sourdough |
| Brewer's Yeast --> Sourdough | Active comparator | Brewer's Yeast --> Sourdough
1. administration of two 100 g croissants prepared with brewer's yeast after an overnight fast.
2. Magnetic Resonance (MR) Imaging analysis of gastric emptying, evaluation of postprandial gastrointestinal fermentation, croissant palatability, gastrointestinal symptoms and perceptions, and serum glucose levels at several time points.
3. washout period: 7 days
4. administration of two 100 g croissants prepared with sourdough after an overnight fast.
5. Magnetic Resonance (MR) Imaging analysis of gastric emptying, evaluation of postprandial gastrointestinal fermentation, croissant palatability, gastrointestinal symptoms and perceptions, and serum glucose levels at several time points. Receives: Dietary Supplement: Sourdough --> Brewer's Yeast; Dietary Supplement: Brewer's Yeast --> Sourdough |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of gastric emptying
Gastric volume in mL was evaluated by Magnetic Resonance(MR) Imaging using a 3-Tesla MR scanner (Biograph mMR, Siemens Healthcare, Erlangen, Germany) to calculate gastric emptying rate in the 3-hour interval following croissant ingestion
Measured: 0, 3, 6, 9, 12, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 180 minutes after the ingestion of the test meal
Secondary outcomes (5)
Change of gastrointestinal fermentation
Hydrogen breath test (Gastrolyzer+TMMedimar) was performed to measure H2 production expressed in ppm after SC and BC ingestion
Measured: The hydrogen concentration in end expiratory air (expressed in ppm) was determined before consuming the test meal and then at 45, 60, 90, 120, 150, 180 and 240 minutes following meal ingestion.
Palatability
Palatability were evaluated by visual analogue scale (VAS, expressed in mm)
Measured: Croissant palatability was evaluated immediately after meal ingestion
Change of gastrointestinal symptoms
postprandial gastrointestinal symptoms (gastrointestinal discomfort, bloating, nausea, fullness) were evaluated by visual analogue scale (VAS, expressed in mm) over a 4-h period after the meal
Measured: The presence and severity of gastrointestinal symptoms were assessed before test meal ingestion and at 45, 60, 90, 120, 150, 180 and 240 minutes after ingestion.
Change of gastrointestinal perceptions
postprandial gastrointestinal perceptions (hunger, appetite, satiety and gastrointestinal wellbeing) were evaluated by visual analogue scale (VAS, expressed in mm) over a 4-h period after the meal
Measured: The presence and severity of gastrointestinal perceptions were assessed before test meal ingestion and at 45, 60, 90, 120, 150, 180 and 240 minutes after ingestion.
Glycemic profile
blood samples were drawn to measure serum glucose levels in mg/dL
Measured: Blood samples were collected before test meal ingestion and at 15, 45, 60, 90, 120 and 180 minutes after the meal.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start22 Jul 2014
- Primary completion28 Apr 2015
- Study completion28 Apr 2015
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 DyspepsiaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Irccs Sdn
- Sponsor type
- University, hospital or other
- Collaborators
- Federico II University, Fresystem S.p.A.
- Responsible party
- Principal investigator, EMANUELE NICOLAI, Irccs Sdn
- Investigators
- Emanuele Nicolai, Principal investigator, Irccs Sdn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03207516
- Sponsor's protocol ID
- 1-14_Digeribilità
- Acronym
- Digeribilità
- Status last verified
- Jun 2017
- First submitted
- 23 Jun 2017
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Polese B, Nicolai E, Genovese D, Verlezza V, La Sala CN, Aiello M, Inglese M, Incoronato M, Sarnelli G, De Rosa T, Schiatti A, Mondelli F, Ercolini D, Cuomo R. Postprandial Gastrointestinal Function Differs after Acute Administration of Sourdough Compared with Brewer's Yeast Bakery Products in Healthy Adults. J Nutr. 2018 Feb 1;148(2):202-208. doi: 10.1093/jn/nxx049.
PubMed 29490103
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Bakery Products With Sourdough or Brewer's Yeast on Digestive Function: a Double Blind Randomised Study in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03207516
- Acronym / sponsor ID
- Digeribilità / 1-14_Digeribilità
- Conditions
- Dyspepsia
- Keywords
- sourdough; leavening process; fermentation; brewer's yeast
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Irccs SdnUniversity, hospital or other
- Collaborators
- Federico II University, Fresystem S.p.A.
- Study start
- 22 Jul 2014 (actual)
- Primary completion
- 28 Apr 2015 (actual)
- Study completion
- 28 Apr 2015 (actual)
- First posted
- 2 Jul 2017 (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.
In a double-blind, randomised crossover study, two sourdough croissants (SC) or two brewer's yeast croissants (BC) were served to 17 (9 F; Age range 18-40; BMI range 18-24 kg/m2) healthy subjects to evaluate the effects of their ingestion on postprandial gastrointestinal functions. Hydrogen breath test was performed to measure H2 production after SC and BC ingestion. Gastric volume was evaluated by Magnetic Resonance(MR) Imaging to calculate gastric emptying rate in the 3-hour interval following croissant ingestion. Palatability and postprandial gastrointestinal symptoms and perceptions over a 4-h period after the meal were evaluated by visual analogue scale (VAS). In addition, in the 3-hour interval, blood samples were drawn to measure serum glucose levels. The area under the curve (AUC) was employed to evaluate global kinetics of all parameters and the T-test was used to evaluate differences between groups.
Detailed description
In this monocentric study, a double-blind, randomised crossover design was used, with washout periods of at least one week between study days. A standardized meal consisting of two 100 g croissants prepared with sourdough or with brewer's yeast was administered randomly to 17 (9 F; Age range 18-40; BMI range 18-24 kg/m2) healthy subjects after an overnight fast (at least 8 h) and consumed in a 10-minute interval with 300 mL of water. Immediately after meal ingestion, subjects were asked to evaluate croissant palatability. Gastric volume was evaluated by Magnetic Resonance(MR) Imaging to calculate gastric emptying rate in the 3-hour interval following croissant ingestion. Hydrogen breath test was performed to assess gastrointestinal fermentation measuring H2 production after SC and BC ingestion. Postprandial gastrointestinal symptoms and perceptions over a 4-h period after the meal were evaluated by visual analogue scale (VAS). In addition, in the 3-hour interval, blood samples were drawn to measure serum glucose levels. The protocol was repeated twice in each subject, once with sourdough croissants (SC) and once with brewer's yeast croissants (BC), dispensed according to a computer generated randomisation list created by RC following simple randomisation procedures (computerized random numbers). The area under the curve (AUC) was employed to evaluate global kinetics of all parameters and the T-test was used to evaluate differences between groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sourdough --> Brewer's Yeast | Active comparator | Dietary Supplement: Sourdough --> Brewer's Yeast, Dietary Supplement: Brewer's Yeast --> SourdoughSourdough --> Brewer's Yeast 1. administration of two 100 g croissants prepared with sourdough after an overnight fast. 2. Magnetic Resonance (MR) Imaging analysis of gastric emptying, evaluation of postprandial gastrointestinal fermentation, croissant palatability, gastrointestinal symptoms and perceptions, and serum glucose levels at several time points. 3. washout period: 7 days 4. administration of two 100 g croissants prepared with brewer's yeast after an overnight fast. 5. Magnetic Resonance (MR) Imaging analysis of gastric emptying, evaluation of postprandial gastrointestinal fermentation, croissant palatability, gastrointestinal symptoms and perceptions, and serum glucose levels at several time points. |
| Brewer's Yeast --> Sourdough | Active comparator | Dietary Supplement: Sourdough --> Brewer's Yeast, Dietary Supplement: Brewer's Yeast --> SourdoughBrewer's Yeast --> Sourdough 1. administration of two 100 g croissants prepared with brewer's yeast after an overnight fast. 2. Magnetic Resonance (MR) Imaging analysis of gastric emptying, evaluation of postprandial gastrointestinal fermentation, croissant palatability, gastrointestinal symptoms and perceptions, and serum glucose levels at several time points. 3. washout period: 7 days 4. administration of two 100 g croissants prepared with sourdough after an overnight fast. 5. Magnetic Resonance (MR) Imaging analysis of gastric emptying, evaluation of postprandial gastrointestinal fermentation, croissant palatability, gastrointestinal symptoms and perceptions, and serum glucose levels at several time points. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- age ranging between 18 and 40 yrs
- normal-weight (body mass index 18-24.9 kg/m2),
Key exclusion criteria (9 listed)
- smoke
- functional or organic gastrointestinal disease
- gluten allergy
- dyslipidemia
- diabetes
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 |
|---|---|---|
| Sourdough --> Brewer's YeastImpact of bakery products with sourdough or brewer's yeast on digestive function | Dietary supplement | Brewer's Yeast --> Sourdough, Sourdough --> Brewer's Yeast |
| Brewer's Yeast --> SourdoughImpact of bakery products with sourdough or brewer's yeast on digestive function | Dietary supplement | Brewer's Yeast --> Sourdough, Sourdough --> Brewer's Yeast |
Primary outcome
Change of gastric emptying
Time frame: 0, 3, 6, 9, 12, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 180 minutes after the ingestion of the test meal
Gastric volume in mL was evaluated by Magnetic Resonance(MR) Imaging using a 3-Tesla MR scanner (Biograph mMR, Siemens Healthcare, Erlangen, Germany) to calculate gastric emptying rate in the 3-hour interval following croissant ingestion
5 secondary outcomes
Change of gastrointestinal fermentation
Time frame: The hydrogen concentration in end expiratory air (expressed in ppm) was determined before consuming the test meal and then at 45, 60, 90, 120, 150, 180 and 240 minutes following meal ingestion.
Palatability
Time frame: Croissant palatability was evaluated immediately after meal ingestion
Change of gastrointestinal symptoms
Time frame: The presence and severity of gastrointestinal symptoms were assessed before test meal ingestion and at 45, 60, 90, 120, 150, 180 and 240 minutes after ingestion.
Change of gastrointestinal perceptions
Time frame: The presence and severity of gastrointestinal perceptions were assessed before test meal ingestion and at 45, 60, 90, 120, 150, 180 and 240 minutes after ingestion.
Glycemic profile
Time frame: Blood samples were collected before test meal ingestion and at 15, 45, 60, 90, 120 and 180 minutes after the 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 2 Jul 2017.
- Derived from this study: PubMed 29490103Polese B, Nicolai E, Genovese D, Verlezza V, La Sala CN, Aiello M, Inglese M, Incoronato M, Sarnelli G, De Rosa T, Schiatti A, Mondelli F, Ercolini D, Cuomo R. Postprandial Gastrointestinal Function Differs after Acute Administration of Sourdough Compared with Brewer's Yeast Bakery Products in Healthy Adults. J Nutr. 2018 Feb 1;148(2):202-208. doi: 10.1093/jn/nxx049.
- 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.
Emanuele Nicolai principal investigator
Irccs Sdn
Questions about this trial
What is this clinical trial studying?
A study testing Sourdough --> Brewer's Yeast and Brewer's Yeast --> Sourdough in people with Dyspepsia, run by Irccs Sdn.
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 2 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 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Change of gastric emptying (time frame: 0, 3, 6, 9, 12, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 180 minutes after the ingestion of the 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 NCT03207516, 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 2 Jul 2017.