NCT06785831

NutriPlant - Opportunities for Increasing Consumption of Local Fruits and Vegetables

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Institute of Nutrition, Slovenia (Nutris) · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2025-01-20
• Primary completion: 2025-09-01
• Completion: 2026-09-30
• First posted: 2025-01-21
• Last updated: 2025-01-21

Locations

1 site across 1 country: Slovenia