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NCT04590768
Tolerance of Regular Meal Intake With Mycoprotein (TOMMY)
NA trial testing Fermotein based meals in Gastrointestinal Complication in 24 participants. Completed in 2 November 2020.
2 November 2020
Quick facts
| Lead sponsor | Wageningen University and Research |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 24 |
| Start date | 12 October 2020 |
| Primary completion | 2 November 2020 |
| Estimated completion | 2 November 2020 |
| Sites | 1 location across Netherlands |
Drugs / interventions tested
- Fermotein based meals
- Matching control meals with whey protein and wheat bran
Conditions studied
- Gastrointestinal Complication — all drugs for Gastrointestinal Complication →
Sponsor
Wageningen University and Research
Who can join
Adults 18 to 70, any sex, with Gastrointestinal Complication. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study aims to assess the impact of daily intake of 11 grams of Fermotein™ on gastrointestinal complaints and several other health related biomarkers. Furthermore, consumer acceptance is investigated. The study has a randomized parallel design. Two different treatments will be evaluated e.g. a 18-day intervention with fermotein based meals and a 18-day intervention with control meals. At the start and at the end of the intervention, a blood sample will be collected. Questionnaires about gut complaints, stool consistency and frequency, wellbeing, health complaints or other adverse effects will be collected daily during intervention and up to two days after the intervention.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04590768
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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Other Wageningen University and Research trials
Trials by the same sponsor.
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- NCT05762965 — Effect of Galacto-oligosaccharides (GOS) on Faecal Gut Microbiota in Adult Women · NA · completed
- NCT05773625 — JITAIs: Optimization of Effectiveness · NA · completed
- NCT05574530 — Vitamin (VIT) for Vigilance Study · NA · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04590768 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Wageningen University and Research
- Last refreshed: 20 January 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04590768.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing