Evaluation of Safety and Tolerability of a Rapeseed Food Ingredient (RYPSI-ING)

Avena Nordic Grain

Status

Completed

Conditions

Food Safety

Treatments

Other: Rapeseed ingredient (RI)

Other: Control product without added RI

Study type

Interventional

Funder types

Industry

Identifiers

NCT03596346

MFAV009

Details and patient eligibility

About

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.

Full 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.

Enrollment

54 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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