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OpenTrials
Completed

NCT Number: NCT04273659

Combining Cereals With Pulses - Reduced Gastrointestinal Symptoms?

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.

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Key information

Conditions

Unidentified Gastrointestinal Symptoms Following Pulses Consumption

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Biochemistry, University of Turku

Turku, 20014, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pulses and cereals

Dietary Supplement

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

Primary outcomes

  1. Breath gases

    Time frame: Day 4

    Breath hydrogen and methane are measured by Gastrocheck device.

Secondary outcomes

  1. Gastrointestinal symptoms (self-reported)

    Time frame: Day 1-4

    Gastrointestinal symptoms as measured as questionnaires.

Sponsors and collaborators

Lead sponsor

University of Turku

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 18, 2020
Registry last updated
Oct 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.