Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study is designed to assess the safety and tolerability of a novel food ingredient produced from rape seeds supplied as a snack-bar in a 4-week controlled intervention.
An 4-week randomized, double-blind, controlled, parallel-group intervention for assessment of safety and tolerability of a novel rape seed ingredient (RI) followed by a 2-week follow-up period. Baseline measures for digestive symptom frequency questionnaire (DSFQ), blood safety tests and body mass index (BMI) will be collected at screening visit. At the randomization visit, participants' eligibility will be confirmed, and they will be randomly allocated into 2 parallel groups consuming either 20 g (test group) or 0 g (control group) of RI within 2 daily snack bars. During the intervention and follow-up periods participants will bi-weekly respond to a GI symptom questionnaire including DSFQ, stool frequency and stool consistency, and palatability items. At the end of the intervention period (week 4) a clinic visit including BMI and AE recording and blood safety tests will be held.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test group | Active Comparator | 20 g of rapeseed ingredient (RI) daily |
|
| Control group | Placebo Comparator | 0 g of rapeseed ingredient (RI) daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rapeseed ingredient (RI) | Other | 2 snack bars daily containing 10 g of RI each. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in digestive symptom frequency score | Change in composite frequency score of four gastrointestinal (GI) symptoms according to the digestive symptom frequency questionnaire (DSFQ; combined score for four questions ranging from 0 to 16; subjective evaluation) | Change from week 0 to week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events | Number of adverse events (total and per causality category) | 0-6 weeks |
| Change in stool consistency | Change in stool consistency according to Bristol stool form scale (subjective evaluation; range from Type 1 as separate hard lumps to Type 7 as liquid consistency with no solid pieces) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sakari Nieminen, MD | Satucon Oy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Satucon Oy/Pihlajalinna Ite | Kuopio | 70100 | Finland |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
Not provided
Not provided
parallel-group
Not provided
Not provided
double-blind
| Control product without added RI |
| Other |
2 snack bars daily containing 0 g of RI. |
|
| Change from week 0 to week 4 |
| Change in defecation frequency | Change in defecation frequency according to visual analogue scale (VAS; score 0-100; subjective outcome) | Change from week 0 to week 4 |
| Change in clinical significance status of screening blood safety tests | Change in clinical significance status of screening blood safety tests | Change from week -2 to week 4 |
| Change in body mass index (BMI) | Change in BMI due to weight change | Change from week -2 to week 4 |
| Palatability | Palatability of investigational product according to visual analogue scale (VAS; score 0-100; subjective outcome) | 2-4 weeks |
| D008722 | Methods |