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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
54
2 snack bars daily containing 10 g of RI each.
2 snack bars daily containing 0 g of RI.
Satucon Oy/Pihlajalinna Ite
Kuopio, Finland
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)
Time frame: Change from week 0 to week 4
Number of adverse events
Number of adverse events (total and per causality category)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: Change from week -2 to week 4
Change in body mass index (BMI)
Change in BMI due to weight change
Time frame: Change from week -2 to week 4
Palatability
Palatability of investigational product according to visual analogue scale (VAS; score 0-100; subjective outcome)
Time frame: 2-4 weeks
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