Combining Cereals With Pulses - Reduced Gastrointestinal Symptoms?

NCT ID: NCT04273659

Last Updated: 2021-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-12

Study Completion Date

2021-08-30

Brief Summary

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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

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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.

Conditions

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Unidentified Gastrointestinal Symptoms Following Pulses Consumption

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Pulses and Cereal 1

Pulses and cereal 1 containing study product is served. Dietary intervention.

Group Type EXPERIMENTAL

Pulses and cereals

Intervention Type DIETARY_SUPPLEMENT

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

Pulses and Cereal 2

Pulses and cereal 2 containing study product is served. Dietary intervention.

Group Type EXPERIMENTAL

Pulses and cereals

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Pulses and cereals

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Turku

OTHER

Sponsor Role lead

Responsible Party

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Kaisa Linderborg

Professor of Molecular Food Sciences (acting)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kaisa Linderborg, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Biochemistry, University of Turku

Locations

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Department of Biochemistry, University of Turku

Turku, , Finland

Site Status

Countries

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Finland

Other Identifiers

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Pulses

Identifier Type: -

Identifier Source: org_study_id

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