NCT04297852

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2019

Completed
1 year until next milestone

Study Start

First participant enrolled

March 3, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 6, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

February 1, 2022

Status Verified

January 1, 2022

Enrollment Period

2.2 years

First QC Date

February 21, 2019

Last Update Submit

January 25, 2022

Conditions

Recovery

Outcome Measures

Primary Outcomes (1)

  • Inflammatory factors

    F-calprotectin

    3 weeks

Study Arms (2)

Vegan drink

ACTIVE COMPARATOR

Treatment group

Dietary Supplement: Vegan drink

Control

PLACEBO COMPARATOR

Placebo group

Dietary Supplement: Control

Interventions

Vegan drinkDIETARY_SUPPLEMENT

Vegan based drink containing vegetables, fruits and plant oils. Dose: 500 mL a day

Vegan drink
ControlDIETARY_SUPPLEMENT

Placebo drink Dose: 500 mL a day

Control

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus university

Aarhus N, 8200, Denmark

RECRUITING

Study Officials

  • Per B Jeppesen, Prof

    Department of clinical medicin

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Per B Jeppesen, Prof

CONTACT

28151877per.bendix.jeppesen@clin.au.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate. Prof, PhD.

Study Record Dates

First Submitted

February 21, 2019

First Posted

March 6, 2020

Study Start

March 3, 2020

Primary Completion

June 1, 2022

Study Completion

December 1, 2022

Last Updated

February 1, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)