The Function of Nutrition Rich Vegan Drink on Inflammatory Bowel Disease

Sponsor

Per Bendix Jeppesen (Other)

Overall Status

Recruiting

CT.gov ID

NCT04297852

Collaborator

Future Food Innovation (Industry)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Recovery	Dietary Supplement: Vegan drink Dietary Supplement: Control	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

The Function of Nutrition Rich Vegan Drink on Inflammatory Bowel Disease

Actual Study Start Date :

Mar 3, 2020

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Vegan drink Treatment group	Dietary Supplement: Vegan drink Vegan based drink containing vegetables, fruits and plant oils. Dose: 500 mL a day
Placebo Comparator: Control Placebo group	Dietary Supplement: Control Placebo drink Dose: 500 mL a day

Arm

Intervention/Treatment

Active Comparator: Vegan drink

Treatment group

Dietary Supplement: Vegan drink

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

Placebo Comparator: Control

Placebo group

Dietary Supplement: Control

Placebo drink Dose: 500 mL a day

Outcome Measures

Primary Outcome Measures

Inflammatory factors [3 weeks]
F-calprotectin

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aarhus university	Aarhus N		Denmark	8200

Sponsors and Collaborators

Per Bendix Jeppesen
Future Food Innovation

Investigators

Principal Investigator: Per B Jeppesen, Prof, Department of clinical medicin

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Per Bendix Jeppesen, Associate. Prof, PhD., University of Aarhus

ClinicalTrials.gov Identifier:

NCT04297852

Other Study ID Numbers:

VEGJUICE

First Posted:

Mar 6, 2020

Last Update Posted:

Feb 1, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Inflammatory Bowel Diseases

Study Results

No Results Posted as of Feb 1, 2022