Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| L7-50154 | Other Grant/Funding Number | Slovenian Research And Innovation Agency | |
| L7-50154 | Other Grant/Funding Number | Ministry of Agriculture, Forestry and Food (Slovenia) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University Medical Centre Ljubljana | OTHER |
| University of Ljubljana | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psyllium | Active Comparator | Psyllium containing 3 g dietary fibre, daily, for 4 weeks |
|
| Sauerkraut | Experimental | Sauerkraut containing 3 g dietary fibre, daily, for 4 weeks |
|
| Fresh apples | Experimental | Fresh apples containing 3 g dietary fibre, daily, for 4 weeks |
|
| Dried apples | Experimental | Dried apples containing 3 g dietary fibre, daily, for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psyllium | Other | Participants will once daily consume predefined amount of psyllium, corresponding to 3 g of dietary fibre, for 28 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in frequency of complete spontaneous bowel movements (CSBM) / week | Daily measurement of number of complete spontaneous bowel movements | fourth week vs pre-intervention |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Change in constipation symptom score (CSC) | Measurement with constipation symptom score (0-48 points, higher SCS score mean more severe symptoms) | fourth week vs pre-intervention |
| Change in stool consistency using Bristol stool form (BSF) scale |
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anita Kušar, PhD | Contact | 0038659068870 | anita.kusar@nutris.org | |
| Igor Pravst, PhD | Contact | 0038659068871 | igor.pravst@nutris.org |
| Name | Affiliation | Role |
|---|---|---|
| Anita Kušar, PhD | Researcher | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UKC Ljubljana | Ljubljana | 1000 | Slovenia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D011620 | Psyllium |
| ID | Term |
|---|---|
| D010936 | Plant Extracts |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
Not provided
Not provided
Not provided
Intervention include consumption of specific foods, therefore masking to participant and investigatior is not possible. Collected data will be masked for accessor of outcomes.
| 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. |
|
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))
| fourth week vs pre-intervention |
| Change in blood lipids | Laboratory measuremnt of S-Cholesterol, S-HDL-Cholesterol, S-LDL-Cholesterol and S-Triglycerides | in week after intervention vs pre-intervention |
| D004066 | Digestive System Diseases |