Clinical trial NCT03596346: Evaluation of Safety and Tolerability of a Rapeseed Food Ingredient
Official title: Evaluation of Safety and Tolerability of a Rapeseed Food Ingredient Among Generally Healthy Consumers - A Randomized Double-blind, Controlled Parallel-group Four-week Intervention Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Safety
Keywords: Rapeseed
Ingredient
Safety
Tolerability
Lead sponsor: Avena Nordic Grain Oy
Sponsor class: INDUSTRY
First posted: 2018-07-23
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel-group
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in digestive symptom frequency score
timeFrame: Change from week 0 to week 4
Secondary outcomes:
measure: Number of adverse events
timeFrame: 0-6 weeks
measure: Change in stool consistency
timeFrame: Change from week 0 to week 4
measure: Change in defecation frequency
timeFrame: Change from week 0 to week 4
measure: Change in clinical significance status of screening blood safety tests
timeFrame: Change from week -2 to week 4
measure: Change in body mass index (BMI)
timeFrame: Change from week -2 to week 4
measure: Palatability
timeFrame: 2-4 weeks
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Satucon Oy/Pihlajalinna Ite
Study officials:
affiliation: Satucon Oy
name: Sakari Nieminen, MD
role: PRINCIPAL_INVESTIGATOR
References: