RecoveryNCT04297852
The Function of Nutrition Rich Vegan Drink on Inflammatory Bowel Disease
A study testing Vegan drink in people with Recovery, run by Per Bendix Jeppesen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Recovery
- What is being tested?
- Vegan drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 3 Mar 2020to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Aarhus university
Aarhus N, 8200
Per B Jeppesen, Prof, per.bendix.jeppesen@clin.au.dk
About this study
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.
- Conditions
- Recovery
- Being tested
- Vegan drink, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vegan drinkDietary supplement
Vegan based drink containing vegetables, fruits and plant oils. Dose: 500 mL a day
ControlDietary supplement
Placebo drink Dose: 500 mL a day
| Study group | Role | What they receive |
|---|---|---|
| Vegan drink | Active comparator | Treatment group Receives: Dietary Supplement: Vegan drink |
| Control | Placebo comparator | Placebo group Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory factors
F-calprotectin
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start3 Mar 2020
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RecoveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Per Bendix Jeppesen
- Sponsor type
- University, hospital or other
- Collaborators
- Future Food Innovation
- Responsible party
- Sponsor-investigator, Per Bendix Jeppesen, University of Aarhus
- Investigators
- Per B Jeppesen, Prof, Principal investigator, Department of clinical medicin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04297852
- Sponsor's protocol ID
- VEGJUICE
- Status last verified
- Jan 2022
- First submitted
- 21 Feb 2019
- Last updated
- 1 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Function of Nutrition Rich Vegan Drink on Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT04297852
- Acronym / sponsor ID
- VEGJUICE
- Conditions
- Recovery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Per Bendix JeppesenUniversity, hospital or other
- Collaborators
- Future Food Innovation
- Study start
- 3 Mar 2020 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 6 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vegan drink | Active comparator | Dietary Supplement: Vegan drinkTreatment group |
| Control | Placebo comparator | Dietary Supplement: ControlPlacebo group |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vegan drinkVegan based drink containing vegetables, fruits and plant oils. Dose: 500 mL a day | Dietary supplement | Vegan drink |
| ControlPlacebo drink Dose: 500 mL a day | Dietary supplement | Control |
Primary outcome
Inflammatory factors
Time frame: 3 weeks
F-calprotectin
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per B Jeppesen, Prof principal investigator
Department of clinical medicin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vegan drink in people with Recovery, run by Per Bendix Jeppesen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Per B Jeppesen, Prof (28151877, per.bendix.jeppesen@clin.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammatory factors (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2022.