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Completed

NCT Number: NCT03596346

Evaluation of Safety and Tolerability of a Rapeseed Food Ingredient

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.

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Key information

Conditions

Food Safety

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Satucon Oy/Pihlajalinna Ite

Kuopio, 70100, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rapeseed ingredient (RI)

Other

2 snack bars daily containing 10 g of RI each.

Control product without added RI

Other

2 snack bars daily containing 0 g of RI.

Primary outcomes

  1. Change in digestive symptom frequency score

    Time frame: Change from week 0 to week 4

    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)

Secondary outcomes

  1. Number of adverse events

    Time frame: 0-6 weeks

    Number of adverse events (total and per causality category)

  2. Change in stool consistency

    Time frame: Change from week 0 to week 4

    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)

  3. Change in defecation frequency

    Time frame: Change from week 0 to week 4

    Change in defecation frequency according to visual analogue scale (VAS; score 0-100; subjective outcome)

  4. Change in clinical significance status of screening blood safety tests

    Time frame: Change from week -2 to week 4

    Change in clinical significance status of screening blood safety tests

  5. Change in body mass index (BMI)

    Time frame: Change from week -2 to week 4

    Change in BMI due to weight change

  6. Palatability

    Time frame: 2-4 weeks

    Palatability of investigational product according to visual analogue scale (VAS; score 0-100; subjective outcome)

Sponsors and collaborators

Lead sponsor

Avena Nordic Grain Oy

Industry

Registry information

Official study 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

Acronym: RYPSI-ING

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 23, 2018
Registry last updated
Nov 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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