NutriPlant - Opportunities for Increasing Consumption of Local Fruits and Vegetables
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Psyllium, Sauerkraut, Fresh apples, Dried apples.
- Who it may be relevant to
- Registry conditions: Functional Constipation, Irritable Bowel Syndrome. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Slovenia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Opportunities for Increasing Consumption of Local Fruits and Vegetables in Slovenian Population (NutriPlant)
Overview
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.
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.
Primary outcome measures
- Change in frequency of complete spontaneous bowel movements (CSBM) / week [Time frame: fourth week vs pre-intervention]
Eligibility criteria
- 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)
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Slovenia · 1 center
- UKC Ljubljana — Ljubljana
Identifiers
NCT: NCT06785831 · KME 0120-242/2024-2711-4 · L7-50154 · L7-50154