Food SafetyRYPSI-INGNCT03596346
Evaluation of Safety and Tolerability of a Rapeseed Food Ingredient
A study testing Rapeseed ingredient (RI) in people with Food Safety, run by Avena Nordic Grain Oy at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Safety
- What is being tested?
- Rapeseed ingredient (RI)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteFinland
- Study dates
- 4 Jul 2018to 25 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed 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.
- Conditions
- Food Safety
- Being tested
- Rapeseed ingredient (RI), Control product without added RI
- Keywords
- Rapeseed, Ingredient, Safety, Tolerability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapeseed ingredient (RI)Other
2 snack bars daily containing 10 g of RI each.
Control product without added RIOther
2 snack bars daily containing 0 g of RI.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Active comparator | 20 g of rapeseed ingredient (RI) daily Receives: Other: Rapeseed ingredient (RI) |
| Control group | Placebo comparator | 0 g of rapeseed ingredient (RI) daily Receives: Other: Control product without added RI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Change from week 0 to week 4
Secondary outcomes (6)
Number of adverse events
Number of adverse events (total and per causality category)
Measured: 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)
Measured: 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)
Measured: 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
Measured: Change from week -2 to week 4
Change in body mass index (BMI)
Change in BMI due to weight change
Measured: Change from week -2 to week 4
Palatability
Palatability of investigational product according to visual analogue scale (VAS; score 0-100; subjective outcome)
Measured: 2-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study start4 Jul 2018
- Primary completion25 Oct 2018
- Study completion25 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food SafetyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- parallel-group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avena Nordic Grain Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sakari Nieminen, MD, Principal investigator, Satucon Oy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03596346
- Sponsor's protocol ID
- MFAV009
- Acronym
- RYPSI-ING
- Status last verified
- Jun 2018
- First submitted
- 19 Jun 2018
- Last updated
- 30 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03596346
- Acronym / sponsor ID
- RYPSI-ING / MFAV009
- Conditions
- Food Safety
- Keywords
- Rapeseed, Ingredient, Safety, Tolerability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Avena Nordic Grain OyIndustry (pharma, biotech, devices)
- Study start
- 4 Jul 2018 (actual)
- Primary completion
- 25 Oct 2018 (actual)
- Study completion
- 25 Oct 2018 (actual)
- First posted
- 23 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- parallel-group
| Arm | Type | Receives |
|---|---|---|
| Test group | Active comparator | Other: Rapeseed ingredient (RI)20 g of rapeseed ingredient (RI) daily |
| Control group | Placebo comparator | Other: Control product without added RI0 g of rapeseed ingredient (RI) daily |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapeseed ingredient (RI)2 snack bars daily containing 10 g of RI each. | Other | Test group |
| Control product without added RI2 snack bars daily containing 0 g of RI. | Other | Control group |
Primary outcome
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)
6 secondary outcomes
Number of adverse events
Time frame: 0-6 weeks
Change in stool consistency
Time frame: Change from week 0 to week 4
Change in defecation frequency
Time frame: Change from week 0 to week 4
Change in clinical significance status of screening blood safety tests
Time frame: Change from week -2 to week 4
Change in body mass index (BMI)
Time frame: Change from week -2 to week 4
Palatability
Time frame: 2-4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sakari Nieminen, MD principal investigator
Satucon Oy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapeseed ingredient (RI) in people with Food Safety, run by Avena Nordic Grain Oy at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in digestive symptom frequency score (time frame: Change from week 0 to week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2018.