Sourdough Bakery Products and Digestive Function

Study Overview
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Brief Summary
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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
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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.

Official Title
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Impact of Bakery Products With Sourdough or Brewer's Yeast on Digestive Function: a Double Blind Randomised Study in Healthy Subjects

Conditions
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Dyspepsia

Intervention / Treatment
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* Dietary Supplement: Sourdough --> Brewer's Yeast
* Dietary Supplement: Brewer's Yeast --> Sourdough


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: age ranging between 18 and 40 yrs normal-weight (body mass index 18-24.9 kg/m2), Exclusion criteria: smoke functional or organic gastrointestinal disease gluten allergy dyslipidemia diabetes psychiatric disorders claustrophobia pregnancy breast-feeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sourdough --> Brewer's Yeast<br>Sourdough --> Brewer's Yeast administration of two 100 g croissants prepared with sourdough after an overnight fast. 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. washout period: 7 days administration of two 100 g croissants prepared with brewer's yeast after an overnight fast. 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. | Dietary Supplement: Sourdough --> Brewer's Yeast<br>* Impact of bakery products with sourdough or brewer's yeast on digestive function<br>Dietary Supplement: Brewer's Yeast --> Sourdough<br>* Impact of bakery products with sourdough or brewer's yeast on digestive function<br>|
| Active Comparator: Brewer's Yeast --> Sourdough<br>Brewer's Yeast --> Sourdough administration of two 100 g croissants prepared with brewer's yeast after an overnight fast. 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. washout period: 7 days administration of two 100 g croissants prepared with sourdough after an overnight fast. 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. | Dietary Supplement: Sourdough --> Brewer's Yeast<br>* Impact of bakery products with sourdough or brewer's yeast on digestive function<br>Dietary Supplement: Brewer's Yeast --> Sourdough<br>* Impact of bakery products with sourdough or brewer's yeast on digestive function<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of gastrointestinal fermentation | Hydrogen breath test (Gastrolyzer+TMMedimar) was performed to measure H2 production expressed in ppm after SC and BC ingestion | 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) | 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 | 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 | 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 | Blood samples were collected before test meal ingestion and at 15, 45, 60, 90, 120 and 180 minutes after the meal. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sourdough; leavening process; fermentation; brewer's yeast