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NCT Number: NCT06785831

NutriPlant - Opportunities for Increasing Consumption of Local Fruits and Vegetables

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.

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Key information

Conditions

Functional Constipation Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Irritable Bowel Syndrome

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Psyllium

Other

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

Sauerkraut

Other

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

Fresh apples

Other

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

Dried apples

Other

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

Primary outcomes

  1. Change in frequency of complete spontaneous bowel movements (CSBM) / week

    Time frame: fourth week vs pre-intervention

    Daily measurement of number of complete spontaneous bowel movements

Other outcomes

  1. Change in constipation symptom score (CSC)

    Time frame: fourth week vs pre-intervention

    Measurement with constipation symptom score (0-48 points, higher SCS score mean more severe symptoms)

  2. Change in stool consistency using Bristol stool form (BSF) scale

    Time frame: fourth week vs pre-intervention

    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))

  3. Change in blood lipids

    Time frame: in week after intervention vs pre-intervention

    Laboratory measuremnt of S-Cholesterol, S-HDL-Cholesterol, S-LDL-Cholesterol and S-Triglycerides

Study contacts

Contact information is provided by the study sponsor or research team.

Anita Kušar, PhD

CONTACT

[email protected]

0038659068870

Igor Pravst, PhD

CONTACT

[email protected]

0038659068871

Sponsors and collaborators

Lead sponsor

Institute of Nutrition, Slovenia (Nutris)

Other

Collaborators

  • University Medical Centre Ljubljana
  • University of Ljubljana

Registry information

Official study title

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

Acronym: NutriPlant

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jan 21, 2025
Registry last updated
Jan 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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