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

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

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.

Study Overview

• Status: Completed
• Conditions: Food Safety
• Intervention / Treatment: Other: Rapeseed ingredient (RI); Other: Control product without added RI

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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Kuopio, Finland, 70100
    • Satucon Oy/Pihlajalinna Ite

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Test group; 20 g of rapeseed ingredient (RI) daily	Other: Rapeseed ingredient (RI); 2 snack bars daily containing 10 g of RI each.
Placebo Comparator: Control group; 0 g of rapeseed ingredient (RI) daily	Other: Control product without added RI; 2 snack bars daily containing 0 g of RI.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Change from week 0 to week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of adverse events	Number of adverse events (total and per causality category)	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)	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)	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	Change from week -2 to week 4
Change in body mass index (BMI)	Change in BMI due to weight change	Change from week -2 to week 4
Palatability	Palatability of investigational product according to visual analogue scale (VAS; score 0-100; subjective outcome)	2-4 weeks

Collaborators and Investigators

• Sponsor: Avena Nordic Grain Oy
• Investigators: Principal Investigator: Sakari Nieminen, MD, Satucon oy

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2018
• Primary Completion (Actual): October 25, 2018
• Study Completion (Actual): October 25, 2018

Study Registration Dates

• First Submitted: June 19, 2018
• First Submitted That Met QC Criteria: July 20, 2018
• First Posted (Actual): July 23, 2018

Study Record Updates

• Last Update Posted (Actual): November 30, 2018
• Last Update Submitted That Met QC Criteria: November 29, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Safety; Tolerability; Rapeseed; Ingredient
• Other Study ID Numbers: MFAV009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No