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Completed

NCT Number: NCT03207516

Sourdough Bakery Products and Digestive Function

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sourdough --> Brewer's Yeast

Dietary Supplement

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

Brewer's Yeast --> Sourdough

Dietary Supplement

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Irccs Sdn

Other

Collaborators

  • Federico II University
  • Fresystem S.p.A.

Registry information

Official study title

Impact of Bakery Products With Sourdough or Brewer's Yeast on Digestive Function: a Double Blind Randomised Study in Healthy Subjects

Acronym: Digeribilità

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 2, 2017
Registry last updated
Jul 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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