NutriPlant - Opportunities for Increasing Consumption of Local Fruits and Vegetables (NutriPlant)

Opportunities for Increasing Consumption of Local Fruits and Vegetables in Slovenian Population (NutriPlant)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Irritable Bowel Syndrome; Functional Constipation
• Intervention / Treatment: Other: Psyllium; Other: Sauerkraut; Other: Fresh apples; Other: Dried apples

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anita Kušar, PhD; Phone Number: 0038659068870; Email: anita.kusar@nutris.org
• Study Contact Backup: Name: Igor Pravst, PhD; Phone Number: 0038659068871; Email: igor.pravst@nutris.org

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • UKC Ljubljana
    • Contact: Darko Siuka, PhD; Phone Number: +486 1 522 26 39; Email: darko.siuka@kclj.si
    • Principal Investigator: Borut Štabuc, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

1. Inclusion criteria:

   • Signed informed consent of the participant to participate in the study
   • Age between 18 and 70 years
   • Functional constipation or irritable bowel syndrome
   • Expressed willingness to eat the investigated food daily (sauerkraut, apples, dried apples or psyllium; period of four weeks)

2. Exclusion criteria:

   • Known allergy to the investigated foods (fresh apples, dried apples, sauerkraut or psyllium)
   • Pregnancy or breastfeeding
   • Previous gastrointestinal surgery with the exception of cholecystectomy and appendectomy
   • Other gastrointestinal diseases (chronic inflammatory bowel disease, celiac disease, gastroparesis, etc.)
   • Serious chronic diseases
   • Introduction of extensive changes in diet or physical activity in the last 4 weeks before the inclusion examination
   • Regular use of laxatives or inability to stop using laxatives for the duration of the study
   • Concurrent participation in another study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Psyllium; Psyllium containing 3 g dietary fibre, daily, for 4 weeks	Other: Psyllium; Participants will once daily consume predefined amount of psyllium, corresponding to 3 g of dietary fibre, for 28 days.
Experimental: Sauerkraut; Sauerkraut containing 3 g dietary fibre, daily, for 4 weeks	Other: Sauerkraut; Participants will once daily consume predefined amount of sauerkraut, corresponding to 3 g of dietary fibre, for 28 days.
Experimental: Fresh apples; Fresh apples containing 3 g dietary fibre, daily, for 4 weeks	Other: Fresh apples; Participants will once daily consume predefined amount of fresh apples, corresponding to 3 g of dietary fibre, for 28 days.
Experimental: Dried apples; Dried apples containing 3 g dietary fibre, daily, for 4 weeks	Other: Dried apples; Participants will once daily consume predefined amount of dried apples, corresponding to 3 g of dietary fibre, for 28 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in frequency of complete spontaneous bowel movements (CSBM) / week	Daily measurement of number of complete spontaneous bowel movements	fourth week vs pre-intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in constipation symptom score (CSC)	Measurement with constipation symptom score (0-48 points, higher SCS score mean more severe symptoms)	fourth week vs pre-intervention
Change in stool consistency using Bristol stool form (BSF) scale	Measurement with Bristol stool form (BSF) scale (Type 1: Separate hard lumps, like nuts (difficult to pass), Type 2: Sausage-shaped, but lumpy, Type 3: Like a sausage but with cracks on its surface, Type 4: Like a sausage or snake, smooth and soft (average stool), Type 5: Soft blobs with clear cut edges, Type 6: Fluffy pieces with ragged edges, a mushy stool (diarrhea), Type 7: Watery, no solid pieces, entirely liquid (diarrhea))	fourth week vs pre-intervention
Change in blood lipids	Laboratory measuremnt of S-Cholesterol, S-HDL-Cholesterol, S-LDL-Cholesterol and S-Triglycerides	in week after intervention vs pre-intervention

Collaborators and Investigators

• Sponsor: Nutrition Institute, Slovenia
• Collaborators: University Medical Centre Ljubljana; University of Ljubljana
• Investigators: Study Director: Anita Kušar, PhD, Researcher

Study record dates

Study Major Dates

• Study Start (Estimated): January 20, 2025
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: December 13, 2024
• First Submitted That Met QC Criteria: January 14, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 14, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Colonic Diseases, Functional; Irritable Bowel Syndrome; Constipation; Gastrointestinal Agents; Cathartics; Psyllium
• Other Study ID Numbers: KME 0120-242/2024-2711-4; L7-50154 (Other Grant/Funding Number: Ministry of Agriculture, Forestry and Food)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No