Evaluation of Safety and Tolerability of a Rapeseed Food Ingredient

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Food Safety

Intervention / Treatment
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* Other: Rapeseed ingredient (RI)
* Other: Control product without added RI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: parallel-group
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rapeseed, Ingredient, Safety, Tolerability