Combining Cereals With Pulses - Reduced Gastrointestinal Symptoms?

University of Turku

Status

Completed

Conditions

Unidentified Gastrointestinal Symptoms Following Pulses Consumption

Treatments

Dietary Supplement: Pulses and cereals

Study type

Interventional

Funder types

Other

Identifiers

NCT04273659

Pulses

Details and patient eligibility

About

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.

Full 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.

Enrollment

25 patients

Sex

All

Ages

18 to 64 years old

Volunteers

Accepts Healthy Volunteers

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