Combining Cereals With Pulses - Reduced Gastrointestinal Symptoms?

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04273659

Enrollment

Registered

2020-02-18

Start date

2020-02-12

Completion date

2021-08-30

Last updated

2021-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unidentified Gastrointestinal Symptoms Following Pulses Consumption

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.

Interventions

DIETARY_SUPPLEMENTPulses and cereals

Dietary intervention. Ingestion of pulses with cereals and gastrointestinal health.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Breath gases	Day 4	Breath hydrogen and methane are measured by Gastrocheck device.

Secondary

Measure	Time frame	Description
Gastrointestinal symptoms (self-reported)	Day 1-4	Gastrointestinal symptoms as measured as questionnaires.

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026