Sourdough Bakery Products and Digestive Function (Digeribilità)

Irccs Sdn

Status: Completed

Conditions: Dyspepsia

Treatments: Dietary Supplement: Brewer's Yeast --> Sourdough; Dietary Supplement: Sourdough --> Brewer's Yeast

Study type: Interventional

Funder types: Other

Identifiers

NCT03207516

1-14_Digeribilità

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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17 participants in 2 patient groups

Sourdough --> Brewer's Yeast

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Sourdough --> Brewer's Yeast

Dietary Supplement: Brewer's Yeast --> Sourdough

Brewer's Yeast --> Sourdough

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Sourdough --> Brewer's Yeast

Dietary Supplement: Brewer's Yeast --> Sourdough