Sourdough Bakery Products and Digestive Function (Digeribilità)

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.

Study Overview

• Status: Completed
• Conditions: Dyspepsia
• Intervention / Treatment: Dietary supplement: Sourdough --> Brewer's Yeast; Dietary supplement: Brewer's Yeast --> Sourdough

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 Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sourdough --> Brewer's Yeast; 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; Impact of bakery products with sourdough or brewer's yeast on digestive function; Dietary supplement: Brewer's Yeast --> Sourdough; Impact of bakery products with sourdough or brewer's yeast on digestive function
Active Comparator: Brewer's Yeast --> Sourdough; 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; Impact of bakery products with sourdough or brewer's yeast on digestive function; Dietary supplement: Brewer's Yeast --> Sourdough; Impact of bakery products with sourdough or brewer's yeast on digestive function

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Irccs Sdn
• Collaborators: Federico II University; Fresystem S.p.A.
• Investigators: Principal Investigator: Emanuele Nicolai, Irccs Sdn

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2014
• Primary Completion (Actual): April 28, 2015
• Study Completion (Actual): April 28, 2015

Study Registration Dates

• First Submitted: June 23, 2017
• First Submitted That Met QC Criteria: June 30, 2017
• First Posted (Actual): July 2, 2017

Study Record Updates

• Last Update Posted (Actual): July 2, 2017
• Last Update Submitted That Met QC Criteria: June 30, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: sourdough; leavening process; fermentation; brewer's yeast
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Dyspepsia
• Other Study ID Numbers: 1-14_Digeribilità

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No