Sourdough Bakery Products and Digestive Function

Dyspepsia Clinical Trial

— Digeribilità  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03207516
• Other study ID #: 1-14_Digeribilità
• Status: Completed
• Phase: N/A
• First received: June 23, 2017
• Last updated: June 30, 2017
• Start date: July 22, 2014
• Est. completion date: April 28, 2015

Study information

• Verified date: June 2017
• Source: Irccs Sdn
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: April 28, 2015
• Est. primary completion date: April 28, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyspepsia

Intervention

Dietary Supplement:
• Sourdough --> Brewer's Yeast
Impact of bakery products with sourdough or brewer's yeast on digestive function
• Brewer's Yeast --> Sourdough
Impact of bakery products with sourdough or brewer's yeast on digestive function

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Irccs Sdn	Federico II University, Fresystem S.p.A.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Change of gastrointestinal fermentation	Hydrogen breath test (Gastrolyzer+TMMedimar) was performed to measure H2 production expressed in ppm after SC and BC ingestion	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.
Secondary	Palatability	Palatability were evaluated by visual analogue scale (VAS, expressed in mm)	Croissant palatability was evaluated immediately after meal ingestion
Secondary	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	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.
Secondary	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	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.
Secondary	Glycemic profile	blood samples were drawn to measure serum glucose levels in mg/dL	Blood samples were collected before test meal ingestion and at 15, 45, 60, 90, 120 and 180 minutes after the meal.