The Function of Nutrition Rich Vegan Drink on Inflammatory Bowel Disease

NCT ID: NCT04297852

Last Updated: 2022-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-03

Study Completion Date

2022-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Recovery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Vegan drink

Treatment group

Group Type ACTIVE_COMPARATOR

Vegan drink

Intervention Type DIETARY_SUPPLEMENT

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

Control

Placebo group

Group Type PLACEBO_COMPARATOR

Control

Intervention Type DIETARY_SUPPLEMENT

Placebo drink Dose: 500 mL a day

Interventions

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Vegan drink

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

Intervention Type DIETARY_SUPPLEMENT

Control

Placebo drink Dose: 500 mL a day

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Future Food Innovation

INDUSTRY

Sponsor Role collaborator

Per Bendix Jeppesen

OTHER

Sponsor Role lead

Responsible Party

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Per Bendix Jeppesen

Associate. Prof, PhD.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Per B Jeppesen, Prof

Role: PRINCIPAL_INVESTIGATOR

Department of clinical medicin

Locations

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Aarhus university

Aarhus N, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Per B Jeppesen, Prof

Role: CONTACT

Facility Contacts

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Per B Jeppesen, Prof

Role: primary

Other Identifiers

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VEGJUICE

Identifier Type: -

Identifier Source: org_study_id

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