Combining Cereals With Pulses - Reduced Gastrointestinal Symptoms?

Not Applicable

Completed

• Conditions: Unidentified Gastrointestinal Symptoms Following Pulses Consumption
• Interventions: Dietary Supplement: Pulses and cereals

• Registration Number: NCT04273659
• Lead Sponsor: University of Turku

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2020-02-12
• Study First Submitted: 2020-02-14
• Study First Submitted QC: 2020-02-14
• Study First Posted: 2020-02-18
• Primary Completion: 2021-08-30
• Study Completion: 2021-08-30
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-04
• Last Update Posted: 2021-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Pulses and Cereal 1	Pulses and cereals	Pulses and cereal 1 containing study product is served. Dietary intervention.
Pulses and Cereal 2	Pulses and cereals	Pulses and cereal 2 containing study product is served. Dietary intervention.

Primary Outcome Measures

Name	Time	Method
Breath gases	Day 4	Breath hydrogen and methane are measured by Gastrocheck device.

Secondary Outcome Measures

Name	Time	Method
Gastrointestinal symptoms (self-reported)	Day 1-4	Gastrointestinal symptoms as measured as questionnaires.

Trial Locations

Locations (1)

Department of Biochemistry, University of Turku; 🇫🇮 Turku, Finland