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Trial record 6 of 228 for:    yeast

Sourdough Bakery Products and Digestive Function (Digeribilità)

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ClinicalTrials.gov Identifier: NCT03207516
Recruitment Status : Completed
First Posted : July 2, 2017
Last Update Posted : July 2, 2017
Sponsor:
Collaborators:
Federico II University
Fresystem S.p.A.
Information provided by (Responsible Party):
EMANUELE NICOLAI, Irccs Sdn

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.

Condition or disease Intervention/treatment Phase
Dyspepsia Dietary Supplement: Sourdough --> Brewer's Yeast Dietary Supplement: Brewer's Yeast --> Sourdough Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Impact of Bakery Products With Sourdough or Brewer's Yeast on Digestive Function: a Double Blind Randomised Study in Healthy Subjects
Actual Study Start Date : July 22, 2014
Actual Primary Completion Date : April 28, 2015
Actual Study Completion Date : April 28, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion

Arm Intervention/treatment
Active Comparator: Sourdough --> Brewer's Yeast

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
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

  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
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




Primary Outcome Measures :
  1. Change of gastric emptying [ 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 ]
    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 :
  1. Change of gastrointestinal fermentation [ 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. ]
    Hydrogen breath test (Gastrolyzer+TMMedimar) was performed to measure H2 production expressed in ppm after SC and BC ingestion

  2. Palatability [ Time Frame: Croissant palatability was evaluated immediately after meal ingestion ]
    Palatability were evaluated by visual analogue scale (VAS, expressed in mm)

  3. Change of gastrointestinal symptoms [ 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. ]
    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

  4. Change of gastrointestinal perceptions [ 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. ]
    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

  5. Glycemic profile [ Time Frame: Blood samples were collected before test meal ingestion and at 15, 45, 60, 90, 120 and 180 minutes after the meal. ]
    blood samples were drawn to measure serum glucose levels in mg/dL



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03207516


Sponsors and Collaborators
Irccs Sdn
Federico II University
Fresystem S.p.A.
Investigators
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Principal Investigator: Emanuele Nicolai Irccs Sdn

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: EMANUELE NICOLAI, Principal Investigator, Irccs Sdn
ClinicalTrials.gov Identifier: NCT03207516     History of Changes
Other Study ID Numbers: 1-14_Digeribilità
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by EMANUELE NICOLAI, Irccs Sdn:
sourdough; leavening process; fermentation; brewer's yeast
Additional relevant MeSH terms:
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Dyspepsia
Signs and Symptoms, Digestive
Signs and Symptoms