Food Safety
Conditions
Keywords
Rapeseed, Ingredient, Safety, Tolerability
Brief summary
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.
Detailed description
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.
Interventions
OTHERRapeseed ingredient (RI)
2 snack bars daily containing 10 g of RI each.
OTHERControl product without added RI
2 snack bars daily containing 0 g of RI.
Sponsors
Avena Nordic Grain Oy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
double-blind
Intervention model description
parallel-group
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Signed written informed consent * Age 18-75 years (inclusive) * Body mass index (BMI) 18.5 - 30 (inclusive) * Good general health according to medical history and current health status
Exclusion criteria
* Allergy or sensitivity to any ingredient of the study products * Nut or mustard allergy * Any major diseases or malfunctions including i. Inflammatory bowel disease or functional bowel disorder or any major gastrointestinal medical condition ii. type 1 or 2 diabetes requiring medication iii. active hepatic, kidney or thyroid disease or disorder except if subject on thyroid replacement therapy iv. myocardial infarction, unstable symptomatic angina pectoris, or transient ischemic attack or stroke within 3 months prior to screening v. cancer or cancer treatment within 5 years prior to screening (not including basal cell carcinoma) * Medication used for treatment of elevated blood glucose levels * Pregnancy, lactation or planned pregnancy during the trial * Clinically significant abnormalities in safety laboratory values according to the investigator * Strict low-carbohydrate or low-fat diet * Participation in another clinical trial in the preceding 1 month * Likelihood of any health or safety risk according to the Investigator * Likelihood of non-compliance according to the Investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in digestive symptom frequency score | Change from week 0 to week 4 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in stool consistency | Change from week 0 to week 4 | 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) |
| Change in defecation frequency | Change from week 0 to week 4 | Change in defecation frequency according to visual analogue scale (VAS; score 0-100; subjective outcome) |
| Number of adverse events | 0-6 weeks | Number of adverse events (total and per causality category) |
| Change in body mass index (BMI) | Change from week -2 to week 4 | Change in BMI due to weight change |
| Palatability | 2-4 weeks | Palatability of investigational product according to visual analogue scale (VAS; score 0-100; subjective outcome) |
| Change in clinical significance status of screening blood safety tests | Change from week -2 to week 4 | Change in clinical significance status of screening blood safety tests |
Countries
Finland
Outcome results
None listed