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NutriPlant - Opportunities for Increasing Consumption of Local Fruits and Vegetables

NCT06785831 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-01-21

No results posted yet for this study

Summary

The effects of different foods to normal bowel function in adult population will be investigated. A randomised controlled intervention trial will be conducted on about 120 (30 per group) adult (18-70 years) subjects with functional constipation and irritable bowel syndrome with constipation according to the IV. Rome criteria. At least one week before inclusion in the study, patients will stop taking laxatives and other anti-constipation medications. Subjects will be randomly selected to consume one of the test foods (fresh apples, dried apples, sauerkraut) or the active control (psyllium) in the equivalent amount of 3 g of fiber per day for 4 weeks. Subjects will be asked not to change their lifestyle habits, such as diet and physical activity level, and not to take oral laxatives during the period of participation in the study.

Conditions

  • Functional Constipation
  • Irritable Bowel Syndrome

Interventions

OTHER

Psyllium

Participants will once daily consume predefined amount of psyllium, corresponding to 3 g of dietary fibre, for 28 days.

OTHER

Sauerkraut

Participants will once daily consume predefined amount of sauerkraut, corresponding to 3 g of dietary fibre, for 28 days.

OTHER

Fresh apples

Participants will once daily consume predefined amount of fresh apples, corresponding to 3 g of dietary fibre, for 28 days.

OTHER

Dried apples

Participants will once daily consume predefined amount of dried apples, corresponding to 3 g of dietary fibre, for 28 days.

Sponsors & Collaborators

  • University Medical Centre Ljubljana

    collaborator OTHER

  • University of Ljubljana

    collaborator OTHER

  • Institute of Nutrition, Slovenia (Nutris)

    lead OTHER

Principal Investigators

  • Anita Kušar, PhD · Researcher

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-20
Primary Completion
2025-09-01
Completion
2026-09-30

Countries

  • Slovenia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06785831 on ClinicalTrials.gov