search
Back to results

Sourdough Bakery Products and Digestive Function (Digeribilità)

Primary Purpose

Dyspepsia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sourdough --> Brewer's Yeast
Brewer's Yeast --> Sourdough
Sponsored by
Irccs Sdn
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dyspepsia focused on measuring sourdough; leavening process; fermentation; brewer's yeast

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Sourdough --> Brewer's Yeast

    Brewer's Yeast --> Sourdough

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Change of gastrointestinal fermentation
    Hydrogen breath test (Gastrolyzer+TMMedimar) was performed to measure H2 production expressed in ppm after SC and BC ingestion
    Palatability
    Palatability were evaluated by visual analogue scale (VAS, expressed in mm)
    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
    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
    Glycemic profile
    blood samples were drawn to measure serum glucose levels in mg/dL

    Full Information

    First Posted
    June 23, 2017
    Last Updated
    June 30, 2017
    Sponsor
    Irccs Sdn
    Collaborators
    Federico II University, Fresystem S.p.A.
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03207516
    Brief Title
    Sourdough Bakery Products and Digestive Function
    Acronym
    Digeribilità
    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

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    July 22, 2014 (Actual)
    Primary Completion Date
    April 28, 2015 (Actual)
    Study Completion Date
    April 28, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Irccs Sdn
    Collaborators
    Federico II University, Fresystem S.p.A.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dyspepsia
    Keywords
    sourdough; leavening process; fermentation; brewer's yeast

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    17 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Sourdough --> Brewer's Yeast
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Brewer's Yeast --> Sourdough
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Sourdough --> Brewer's Yeast
    Intervention Description
    Impact of bakery products with sourdough or brewer's yeast on digestive function
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Brewer's Yeast --> Sourdough
    Intervention Description
    Impact of bakery products with sourdough or brewer's yeast on digestive function
    Primary Outcome Measure Information:
    Title
    Change of gastric emptying
    Description
    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
    Time Frame
    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 Measure Information:
    Title
    Change of gastrointestinal fermentation
    Description
    Hydrogen breath test (Gastrolyzer+TMMedimar) was performed to measure H2 production expressed in ppm after SC and BC ingestion
    Time Frame
    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.
    Title
    Palatability
    Description
    Palatability were evaluated by visual analogue scale (VAS, expressed in mm)
    Time Frame
    Croissant palatability was evaluated immediately after meal ingestion
    Title
    Change of gastrointestinal symptoms
    Description
    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
    Time Frame
    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.
    Title
    Change of gastrointestinal perceptions
    Description
    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
    Time Frame
    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.
    Title
    Glycemic profile
    Description
    blood samples were drawn to measure serum glucose levels in mg/dL
    Time Frame
    Blood samples were collected before test meal ingestion and at 15, 45, 60, 90, 120 and 180 minutes after the meal.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Emanuele Nicolai
    Organizational Affiliation
    Irccs Sdn
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29490103
    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.
    Results Reference
    derived

    Learn more about this trial

    Sourdough Bakery Products and Digestive Function

    We'll reach out to this number within 24 hrs