NutriPlant - Opportunities for Increasing Consumption of Local Fruits and Vegetables

Nutrition Institute, Slovenia

Status: Not yet enrolling

Conditions: Functional Constipation; Irritable Bowel Syndrome

Treatments: Other: Sauerkraut; Other: Fresh apples; Other: Psyllium; Other: Dried apples

Study type: Interventional

Funder types: Other

Identifiers

NCT06785831

L7-50154 (Other Grant/Funding Number)

KME 0120-242/2024-2711-4

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 4 patient groups

Psyllium

Active Comparator group

Description:

Psyllium containing 3 g dietary fibre, daily, for 4 weeks

Treatment:

Other: Psyllium

Sauerkraut

Experimental group

Description:

Sauerkraut containing 3 g dietary fibre, daily, for 4 weeks

Treatment:

Other: Sauerkraut

Fresh apples

Experimental group

Description:

Fresh apples containing 3 g dietary fibre, daily, for 4 weeks

Treatment:

Other: Fresh apples

Dried apples

Experimental group

Description:

Dried apples containing 3 g dietary fibre, daily, for 4 weeks

Treatment:

Other: Dried apples