Clinical TrialID 1111

Evaluation of Safety and Tolerability of a Rapeseed Food Ingredient

NCT03596346

Food Safety

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Trial: 1Herb: 1Links: 1
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Record Fields

Scalar fields from the final clinical_trial record.

Clinical Trial Id
1111
Evidence Id
1111
Core Evidence Id
1111
Source Clinical Trial Id
1093
Herb2 Clinical Trial Id
HBCT001093
Nct Id
NCT03596346
Title
Evaluation of Safety and Tolerability of a Rapeseed Food Ingredient
Status
Completed
Phase
Study Result
No
Study Condition
Food Safety
Study Type
Interventional
Study Design
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Intervention
OTHER: Rapeseed ingredient (RI)|OTHER: Control product without added RI
Intervention Allocation
Randomized
Intervention Model
Parallel
Intervention Mask
Quadruple
Intervention Purpose
Other
Gender
All
Age
Adult, Older_Adult
Enrollment
54
Outcome Measure
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
Sponsor Collaborator
Avena Nordic Grain Oy
Funded By
INDUSTRY
Location
Satucon Oy/Pihlajalinna Ite, Kuopio, 70100, Finland
Other Id
MFAV009
Start Date
2018-07-04
Primary Completion Date
2018-10-25
Completion Date
2018-10-25
First Posted
2018-07-23
Results First Posted
Last Update Posted
2018-11-30
Study Document
Study Url
https://clinicaltrials.gov/study/NCT03596346
Title Cn
Title En
Evaluation of Safety and Tolerability of a Rapeseed Food Ingredient
Bilingual Status
semi_complete