Combining Cereals With Pulses - Reduced Gastrointestinal Symptoms?

Unidentified Gastrointestinal Symptoms Following Pulses Consumption Clinical Trial

Official title:

Combining Cereals With Pulses - Reduced Gastrointestinal Symptoms?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04273659
• Other study ID #: Pulses
• Status: Completed
• Phase: N/A
• Start date: February 12, 2020
• Est. completion date: August 30, 2021

Study information

• Verified date: October 2021
• Source: University of Turku
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to compare self-reported gastrointestinal symptoms and intestinal fermentation rates of the study products as measured by breath hydrogen and methane in adult population with self-reported mild abdominal sensitivity to pulses. The study products are a pulse products with two different cereals.

Description:

The study is a randomized, controlled, double-blind, cross-over intervention trial. The aim is to recruit 25 subjects to the trial. The study will be conducted with a cross-over setting, where the subjects will go through exposure meals and breath gas measurement two times (two different test products) in a randomized order. The study meals are identical in appearance but differ in fiber content. After study breakfast the breath gases are analyzed every 15 minutes during 8 hours.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: August 30, 2021
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• Healthy subjects with subjective experience of gut symptoms after consumption of pulses
• Celiac disease and wheat allergy excluded by antigen test
• Age 18-65
• BMI 18,5 - 30
• Normal liver, thyroid and kidney functions

Exclusion Criteria:

• Celiac disease, Crohn's disease, ulcerative colitis or acute diverticulitis
• Any medication affecting the gastrointestinal tract (e.g. laxatives and acid-suppressive drugs)
• Antibiotic treatment within previous 3 months
• Blood donation or participation to another clinical trial within one month prior to study entry

Related Conditions & MeSH terms

• Gastrointestinal Diseases
• Signs and Symptoms, Digestive
• Unidentified Gastrointestinal Symptoms Following Pulses Consumption

Intervention

Dietary Supplement:
• Pulses and cereals
Dietary intervention. Ingestion of pulses with cereals and gastrointestinal health.

Locations

Country	Name	City	State
Finland	Department of Biochemistry, University of Turku	Turku

Sponsors (1)

Lead Sponsor	Collaborator
University of Turku

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breath gases	Breath hydrogen and methane are measured by Gastrocheck device.	Day 4
Secondary	Gastrointestinal symptoms (self-reported)	Gastrointestinal symptoms as measured as questionnaires.	Day 1-4