Trials / Completed
CompletedNCT03207516
Sourdough Bakery Products and Digestive Function
Impact of Bakery Products With Sourdough or Brewer's Yeast on Digestive Function: a Double Blind Randomised Study in Healthy Subjects
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- Irccs Sdn · Academic / Other
- Sex
- All
- Age
- 18 Years – 40 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2014-07-22
- Primary completion
- 2015-04-28
- Completion
- 2015-04-28
- First posted
- 2017-07-02
- Last updated
- 2017-07-02
Source: ClinicalTrials.gov record NCT03207516. Inclusion in this directory is not an endorsement.