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Evaluation of Safety and Tolerability of a Rapeseed Food Ingredient

NCT ID: NCT03596346

Last Updated: 2018-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-04

Study Completion Date

2018-10-25

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.

Conditions

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Food Safety

Keywords

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Rapeseed Ingredient Safety Tolerability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

parallel-group
Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
double-blind

Study Groups

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Test group

20 g of rapeseed ingredient (RI) daily

Group Type ACTIVE_COMPARATOR

Rapeseed ingredient (RI)

Intervention Type OTHER

2 snack bars daily containing 10 g of RI each.

Control group

0 g of rapeseed ingredient (RI) daily

Group Type PLACEBO_COMPARATOR

Control product without added RI

Intervention Type OTHER

2 snack bars daily containing 0 g of RI.

Interventions

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Rapeseed ingredient (RI)

2 snack bars daily containing 10 g of RI each.

Intervention Type OTHER

Control product without added RI

2 snack bars daily containing 0 g of RI.

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Avena Nordic Grain Oy

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sakari Nieminen, MD

Role: PRINCIPAL_INVESTIGATOR

Satucon Oy

Locations

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Satucon Oy/Pihlajalinna Ite

Kuopio, , Finland

Site Status

Countries

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Finland

Other Identifiers

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MFAV009

Identifier Type: -

Identifier Source: org_study_id