Combining Cereals With Pulses - Reduced Gastrointestinal Symptoms?
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Turku
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Breath gases
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- 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
Arms & Interventions
Pulses and Cereal 1
Pulses and cereal 1 containing study product is served. Dietary intervention.
Intervention: Pulses and cereals (Dietary Supplement)
Pulses and Cereal 2
Pulses and cereal 2 containing study product is served. Dietary intervention.
Intervention: Pulses and cereals (Dietary Supplement)
Outcomes
Primary Outcomes
Breath gases
Time Frame: Day 4
Breath hydrogen and methane are measured by Gastrocheck device.
Secondary Outcomes
- Gastrointestinal symptoms (self-reported)(Day 1-4)
Investigators
Kaisa Linderborg
Professor of Molecular Food Sciences (acting)
University of Turku