Health TrialsbyHealthPanel

NutriPlant - Opportunities for Increasing Consumption of Local Fruits and Vegetables

ConditionsFunctional ConstipationIrritable Bowel Syndrome
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorInstitute of Nutrition, Slovenia (Nutris)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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.)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Psyllium

    Other intervention

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

  • Sauerkraut

    Other intervention

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

  • Fresh apples

    Other intervention

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

  • Dried apples

    Other intervention

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

Treatment groups

120 Participants
are divided into 4 treatment groups
Group A: PsylliumActive comparator 1 intervention
Group B: SauerkrautExperimental treatment 1 intervention
Group C: Fresh applesExperimental treatment 1 intervention
Group D: Dried applesExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Daily measurement of number of complete spontaneous bowel movements

Time frame
fourth week vs pre-intervention

Secondary outcomes

Other outcomes

1

Change in constipation symptom score (CSC)

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

Time frame
fourth week vs pre-intervention
2

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))

Time frame
fourth week vs pre-intervention
3

Change in blood lipids

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

Time frame
in week after intervention vs pre-intervention

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institute of Nutrition, Slovenia (Nutris)

Lead sponsor

University Medical Centre Ljubljana

Collaborator

University of Ljubljana

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: