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NCT03736551: MIX-UP
Intermittent Low Energy Diet in CKD: MIX UP Feasibility Study
NA trial testing 5:2 diet in Chronic Kidney Diseases in 13 participants. Completed in 6 June 2019.
31 December 2018
Quick facts
| Lead sponsor | King's College Hospital NHS Trust |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 13 |
| Start date | 25 October 2017 |
| Primary completion | 31 December 2018 |
| Estimated completion | 6 June 2019 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- 5:2 diet
- Renal Weight Management Programme
Conditions studied
- Chronic Kidney Diseases — all drugs for Chronic Kidney Diseases →
- Obesity — all drugs for Obesity →
Sponsor
King's College Hospital NHS Trust
Who can join
Adults 18 to 75, any sex, with Chronic Kidney Diseases or Obesity. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study proposes to investigate the acceptability and efficacy of intermittent VLED (5:2 diet) plus exercise, compared with the investigator's established Weight Management Programme (WMP), in obese patients with CKD, using feasibility study methodology. Patients will be invited to participate in the parallel arm, single blinded, randomised controlled feasibility study, and randomly allocated to 1 of 2 treatments for 6 months. The experimental arm involves an intermittent modified fasting regimen consisting of VLED (600 kcal/day) on 2 consecutive days, and 5 days each week on a modified diet to maintain an overall energy deficit of 600 kcal/day across the week (5:2 diet). The control arm will be the standard renal WMP with a continuous energy restricted diet aimed at reducing daily energy intake by 600 kcal/day. The feasibility outcomes are: recruitment rate \>50%; intervention retention rate at 6 months \>60%; dietary intervention compliance; and weight loss. Secondary outcomes include safety, body composition, proteinuria, lipids, blood pressure, and eating desire. Measurements will be made at baseline, midpoint, and twice at endpoint.
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 NCT03736551
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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Other recruiting trials for Chronic Kidney Diseases
Currently open trials in the same condition.
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Other King's College Hospital NHS Trust trials
Trials by the same sponsor.
- NCT07384884 — Surgery and Laser Interstitial Thermal Therapy for Bilateral Glioblastomas · NA · not yet recruiting
- NCT07379723 — Brief Intervention for FCD: A Feasibility Study · NA · recruiting
- NCT07062731 — Pelvic Floor Exercises for Suboptimal Anorectal Manometry · recruiting
- NCT06766162 — Virtual Reality to Improve Patient Experience During Endoscopic Mucosal and Submucosal Resection · NA · completed
- NCT06918756 — Development of a Cough Control Questionnaire (CCQ) · recruiting
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 NCT03736551 (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 King's College Hospital NHS Trust
- Last refreshed: 7 September 2020
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/NCT03736551.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing