Clinical trial NCT03207516: Sourdough Bakery Products and Digestive Function
Official title: Impact of Bakery Products With Sourdough or Brewer's Yeast on Digestive Function: a Double Blind Randomised Study in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyspepsia
Keywords: sourdough; leavening process; fermentation; brewer's yeast
Lead sponsor: Irccs Sdn
Sponsor class: OTHER
Collaborators: name: Federico II University
name: Fresystem S.p.A.
First posted: 2017-07-02
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of gastric emptying
timeFrame: 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:
measure: Change of gastrointestinal fermentation
timeFrame: 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.
measure: Palatability
timeFrame: Croissant palatability was evaluated immediately after meal ingestion
measure: Change of gastrointestinal symptoms
timeFrame: 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.
measure: Change of gastrointestinal perceptions
timeFrame: 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.
measure: Glycemic profile
timeFrame: Blood samples were collected before test meal ingestion and at 15, 45, 60, 90, 120 and 180 minutes after the meal.
Other outcomes:
Locations:
Study officials:
affiliation: Irccs Sdn
name: Emanuele Nicolai
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.