Combining Cereals With Pulses - Reduced Gastrointestinal Symptoms?

Study Overview
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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.

Official Title
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Combining Cereals With Pulses - Reduced Gastrointestinal Symptoms?

Conditions
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Unidentified Gastrointestinal Symptoms Following Pulses Consumption

Intervention / Treatment
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* Dietary Supplement: Pulses and cereals


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pulses and Cereal 1<br>Pulses and cereal 1 containing study product is served. Dietary intervention. | Dietary Supplement: Pulses and cereals<br>* Dietary intervention. Ingestion of pulses with cereals and gastrointestinal health.<br>|
| Experimental: Pulses and Cereal 2<br>Pulses and cereal 2 containing study product is served. Dietary intervention. | Dietary Supplement: Pulses and cereals<br>* Dietary intervention. Ingestion of pulses with cereals and gastrointestinal health.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breath gases | Breath hydrogen and methane are measured by Gastrocheck device. | Day 4 | 

Secondary Outcome Measures

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