Combining Cereals With Pulses - Reduced Gastrointestinal Symptoms?

• Sponsor: University of Turku (Other)
• Overall Status: Completed
• CT.gov ID: NCT04273659
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Arms: 2
• Actual Duration (Months): 18.6
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Unidentified Gastrointestinal Symptoms Following Pulses Consumption	Dietary Supplement: Pulses and cereals	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 25 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Combining Cereals With Pulses - Reduced Gastrointestinal Symptoms?
• Actual Study Start Date: Feb 12, 2020
• Actual Primary Completion Date: Aug 30, 2021
• Actual Study Completion Date: Aug 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pulses and Cereal 1 Pulses and cereal 1 containing study product is served. Dietary intervention.	Dietary Supplement: Pulses and cereals; Dietary intervention. Ingestion of pulses with cereals and gastrointestinal health.
Experimental: Pulses and Cereal 2 Pulses and cereal 2 containing study product is served. Dietary intervention.	Dietary Supplement: Pulses and cereals; Dietary intervention. Ingestion of pulses with cereals and gastrointestinal health.

Outcome Measures

Primary Outcome Measures

1. Breath gases [Day 4]

   Breath hydrogen and methane are measured by Gastrocheck device.

Secondary Outcome Measures

1. Gastrointestinal symptoms (self-reported) [Day 1-4]

   Gastrointestinal symptoms as measured as questionnaires.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Biochemistry, University of Turku	Turku		Finland	20014

Sponsors and Collaborators

• University of Turku

Investigators

• Principal Investigator: Kaisa Linderborg, PhD, Department of Biochemistry, University of Turku

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kaisa Linderborg, Professor of Molecular Food Sciences (acting), University of Turku
• ClinicalTrials.gov Identifier: NCT04273659
• Other Study ID Numbers: Pulses
• First Posted: Feb 18, 2020
• Last Update Posted: Oct 5, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Gastrointestinal Diseases; Signs and Symptoms, Digestive

Study Results

No Results Posted as of Oct 5, 2021