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| Name | Class |
|---|---|
| Oy Foodfiles Ltd | OTHER |
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Polydextrose (PDX) (8-30g/day) has been reported to increase faecal bulk and consistency, leading to easier stool passage in healthy subjects. Studies on its effect on defaecation frequency and colonic transit time have provided mixed results. The primary objective was to investigate the effect of PDX consumption by mildly constipated subjects on faecal bulk, measured as total faecal wet weight of 4-day collections. Secondary outcomes (faecal dry weight, defaecation frequency, stool consistency, ease of stool passage, total colonic transit time and gastrointestinal symptoms) were also explored. 51 subjects participated in a 4-week, two-center, randomized, double-blind, placebo-controlled, parallel study testing a control (CON) and a PDX treatment (18 g/d included in biscuits and drink mixtures)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polydextrose (PDX) | Active Comparator | Subject consumed a daily dose of 18g polydextrose enriched drink mixtures and biscuits (12 g from the drink mixtures and 6 g from the biscuits) providing 16.2 g dietary fibre/d. |
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| Control (CON) | Placebo Comparator | Subjects consumed placebo products, where maltodextrin replaced PDX and differed only in the amount of fibre per gram (1.7 g). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polydextrose | Dietary Supplement | Polydextrose-enriched food products |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Faecal bulk | Measured as total faecal wet weight | 4-day collections |
| Measure | Description | Time Frame |
|---|---|---|
| Faecal dry weight | Measured as total faecal dry weight | 4-day collections during the intervention period |
| Defaecation frequency | Recorded as defaecation frequency (i.e. number of stools) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Essi Sarkkinen, PhD | Oy Foodfiles Ltd | Study Director |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C033375 | polydextrose |
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Randomized, double-blind, placebo-controlled, parallel study.
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| placebo-controlled |
| Dietary Supplement |
Control food products |
|
| 7-day period during the run-in period and intervention period |
| Stool consistency | Measured using the Bristol Stool Form (BSF) score (1 = separate hard lumps, like nuts (difficult defaecation), 2 = sausage shaped but lumpy, 3 = like a sausage or snake but with cracks on its surface, 4 = like a sausage or snake, smooth and soft, 5 = soft blobs with clear cut edge, 6 = fluffy pieces with ragged edges, a mushy stool, 7 = watery, no solid pieces) | 7-day period during the run-in period and intervention period |
| Ease of stool passage | Using a five-point scale (1 = very easy, 2 = easy, 3 = neither easy nor difficult, 4 = difficult, 5 = very difficult) | At the end of the intervention period |
| Total colonic transit time | Using radio-opaque, barium sulfate impregnated polyethylene pellets located inside gelatin capsules | At the end of the intervention period for three consecutive days |
| Gastrointestinal symptoms | Subjects ranked ranked the subjective tolerance variables daily to burping, cramping, distension/bloating, flatulence, nausea, reflux (heartburn) and vomiting on a four-point scale (1 = none, 2 = mild, 3 = moderate, 4 = severe) | Once at the end of the intervention period and during the previous one week (7 day-period). |