Sourdough Bakery Products and Digestive Function

NCT03207516 | Completed

• 1 other identifier: 1-14_Digeribilità
• Study Type: interventional
• Target: 17
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dyspepsia

Keywords

sourdough; leavening process; fermentation; brewer's yeast

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change of gastrointestinal fermentation

  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

  Croissant palatability was evaluated immediately after meal ingestion

• Change of gastrointestinal symptoms

  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

  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 collected before test meal ingestion and at 15, 45, 60, 90, 120 and 180 minutes after the meal.

Study Arms (2)

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.

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.

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

Interventions

Sourdough --> Brewer's Yeast DIETARY_SUPPLEMENT

Impact of bakery products with sourdough or brewer's yeast on digestive function

Brewer's Yeast --> Sourdough; Sourdough --> Brewer's Yeast

Brewer's Yeast --> Sourdough DIETARY_SUPPLEMENT

Impact of bakery products with sourdough or brewer's yeast on digestive function

Brewer's Yeast --> Sourdough; Sourdough --> Brewer's Yeast

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• age ranging between 18 and 40 yrs
• normal-weight (body mass index 18-24.9 kg/m2),

You may not qualify if:

• smoke
• functional or organic gastrointestinal disease
• gluten allergy
• dyslipidemia
• diabetes
• psychiatric disorders
• claustrophobia
• pregnancy
• breast-feeding

Sponsors & Collaborators

• Irccs Sdn: lead
• Federico II University: collaborator
• Fresystem S.p.A.: collaborator

Related Publications (1)

• 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.

  PMID: 29490103 DERIVED

MeSH Terms

Conditions

Dyspepsia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Emanuele Nicolai

  Irccs Sdn

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 23, 2017
• First Posted: July 2, 2017
• Study Start: July 22, 2014
• Primary Completion: April 28, 2015
• Study Completion: April 28, 2015
• Last Updated: July 2, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share