NCT03596346

Evaluation of Safety and Tolerability of a Rapeseed Food Ingredient

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Avena Nordic Grain Oy · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Food Safety

Interventions

Type	Name	Description
OTHER	Rapeseed ingredient (RI)	2 snack bars daily containing 10 g of RI each.
OTHER	Control product without added RI	2 snack bars daily containing 0 g of RI.

Timeline

• Start date: 2018-07-04
• Primary completion: 2018-10-25
• Completion: 2018-10-25
• First posted: 2018-07-23
• Last updated: 2018-11-30

Locations

1 site across 1 country: Finland