Evaluation of Safety and Tolerability of a Rapeseed Food Ingredient

Food Safety Clinical Trial

— RYPSI-ING  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03596346
• Other study ID #: MFAV009
• Status: Completed
• Phase: N/A
• Start date: July 4, 2018
• Est. completion date: October 25, 2018

Study information

• Verified date: June 2018
• Source: Avena Nordic Grain Oy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: October 25, 2018
• Est. primary completion date: October 25, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Food Safety

Intervention

Other:
• Rapeseed ingredient (RI)
2 snack bars daily containing 10 g of RI each.
• Control product without added RI
2 snack bars daily containing 0 g of RI.

Locations

Country	Name	City	State
Finland	Satucon Oy/Pihlajalinna Ite	Kuopio

Sponsors (1)

Lead Sponsor	Collaborator
Avena Nordic Grain Oy

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of adverse events	Number of adverse events (total and per causality category)	0-6 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in body mass index (BMI)	Change in BMI due to weight change	Change from week -2 to week 4
Secondary	Palatability	Palatability of investigational product according to visual analogue scale (VAS; score 0-100; subjective outcome)	2-4 weeks