An interventional study of Sourdough --> Brewer's Yeast and Brewer's Yeast --> Sourdough in Dyspepsia, sponsored by Irccs Sdn. Completed. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-02.
Sponsored by Irccs Sdn · Not applicable, Interventional, and Supportive care
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.
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.
363 studies on the registry are indexed under Dyspepsia; 51 are open to participants now.
This study's enrollment of 17 is below the median of 87 across 297 interventional studies indexed under Dyspepsia.
Browse Dyspepsia studies →This is the only study on the registry with Irccs Sdn as lead sponsor.
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Exclusion criteria:
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 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
Impact of bakery products with sourdough or brewer's yeast on digestive function
Impact of bakery products with sourdough or brewer's yeast on digestive function
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
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
Change of gastrointestinal fermentation
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.
Palatability
Palatability were evaluated by visual analogue scale (VAS, expressed in mm)
Time frame: Croissant palatability was evaluated immediately after meal ingestion
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
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.
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
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.
Glycemic profile
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.
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Plan to share: No
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