The Function of Nutrition Rich Vegan Drink on Inflammatory Bowel Disease
Primary Purpose
Recovery
Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Vegan drink
Control
Sponsored by
About this trial
This is an interventional supportive care trial for Recovery
Eligibility Criteria
Inclusion Criteria:
- Between 18 and 85 years old
- Diagnosed with or show signs of UC or Crohns disease
- Mild symptoms i.e intestinal symptoms
- Has had the same medicin the previous week before starting in the study
Exclusion Criteria:
- Food or vegetable allergi
- Cognitive diseases e.g alzheimers or dementia
- Has diabetes requiring insulin or GLP-1 analog treatment (NB: No does include T2D patients, taking tablets or other diabetes therapy)
Sites / Locations
- Aarhus universityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Vegan drink
Control
Arm Description
Treatment group
Placebo group
Outcomes
Primary Outcome Measures
Inflammatory factors
F-calprotectin
Secondary Outcome Measures
Full Information
NCT ID
NCT04297852
First Posted
February 21, 2019
Last Updated
January 25, 2022
Sponsor
Per Bendix Jeppesen
Collaborators
Future Food Innovation
1. Study Identification
Unique Protocol Identification Number
NCT04297852
Brief Title
The Function of Nutrition Rich Vegan Drink on Inflammatory Bowel Disease
Official Title
The Function of Nutrition Rich Vegan Drink on Inflammatory Bowel Disease
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 3, 2020 (Actual)
Primary Completion Date
June 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Per Bendix Jeppesen
Collaborators
Future Food Innovation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of this project, would be to develop a new formula, with high nutrition content on a vegan basis. The investigators expect to produce this novel vegan-based juice product, which does not exist on the marked today. The juice would consist of different selected varieties of vegetables and fruits. Beside the vegetables, the juice will also contain plant oils to increase the calorie level, as well as a protein sources containing amino acids with high anabolic effects.
The products will be tested in an intervention study on patients with inflammatory bowel disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recovery
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vegan drink
Arm Type
Active Comparator
Arm Description
Treatment group
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Placebo group
Intervention Type
Dietary Supplement
Intervention Name(s)
Vegan drink
Intervention Description
Vegan based drink containing vegetables, fruits and plant oils. Dose: 500 mL a day
Intervention Type
Dietary Supplement
Intervention Name(s)
Control
Intervention Description
Placebo drink Dose: 500 mL a day
Primary Outcome Measure Information:
Title
Inflammatory factors
Description
F-calprotectin
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Between 18 and 85 years old
Diagnosed with or show signs of UC or Crohns disease
Mild symptoms i.e intestinal symptoms
Has had the same medicin the previous week before starting in the study
Exclusion Criteria:
Food or vegetable allergi
Cognitive diseases e.g alzheimers or dementia
Has diabetes requiring insulin or GLP-1 analog treatment (NB: No does include T2D patients, taking tablets or other diabetes therapy)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Per B Jeppesen, Prof
Phone
28151877
Email
per.bendix.jeppesen@clin.au.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per B Jeppesen, Prof
Organizational Affiliation
Department of clinical medicin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus university
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Per B Jeppesen, Prof
Email
per.bendix.jeppesen@clin.au.dk
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Function of Nutrition Rich Vegan Drink on Inflammatory Bowel Disease
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