Evaluation of Safety and Tolerability of a Rapeseed Food Ingredient

NCT03596346 | Completed

• 1 other identifier: MFAV009
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Food Safety

Keywords

Rapeseed; Ingredient; Safety; Tolerability

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Number of adverse events

  0-6 weeks

• Change in stool consistency

  Change from week 0 to week 4

• Change in defecation frequency

  Change from week 0 to week 4

• Change in clinical significance status of screening blood safety tests

  Change from week -2 to week 4

• Change in body mass index (BMI)

  Change from week -2 to week 4

Study Arms (2)

Test group

ACTIVE COMPARATOR

20 g of rapeseed ingredient (RI) daily

Other: Rapeseed ingredient (RI)

Control group

PLACEBO COMPARATOR

0 g of rapeseed ingredient (RI) daily

Other: Control product without added RI

Interventions

Rapeseed ingredient (RI) OTHER

2 snack bars daily containing 10 g of RI each.

Test group

Control product without added RI OTHER

2 snack bars daily containing 0 g of RI.

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Avena Nordic Grain Oy: lead

Study Sites (1)

Satucon Oy/Pihlajalinna Ite

Kuopio, 70100, Finland

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Sakari Nieminen, MD

  Satucon Oy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blind
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: parallel-group

Study Record Dates

• First Submitted: June 19, 2018
• First Posted: July 23, 2018
• Study Start: July 4, 2018
• Primary Completion: October 25, 2018
• Study Completion: October 25, 2018
• Last Updated: November 30, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)