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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
Per Bendix Jeppesen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Recovery

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
February 21, 2019
Last Updated
January 25, 2022
Sponsor
Per Bendix Jeppesen
Collaborators
Future Food Innovation
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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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