# A Randomised, Controlled Trial of a Low-energy Diet for Improving Functional Status in Heart Failure With PRESERVED Ejection Fraction Preserved Ejection Fraction

> **NCT05887271** · PHASE2,PHASE3 · RECRUITING · sponsor: **University of Leicester** · enrollment: 63 (estimated)

## Conditions studied

- Heart Failure With Preserved Ejection Fraction
- Heart Failure, Diastolic
- Diabetes Mellitus, Type 2
- Diabetes Mellitus Type 2 in Obese
- Obesity Adult Onset

## Interventions

- **DRUG:** Low calorie meal replacement plan
- **DIAGNOSTIC_TEST:** Cardiovascular magnetic resonance (CMR) imaging and magnetic resonance spectroscopy
- **DIAGNOSTIC_TEST:** Transthoracic echocardiography
- **DIAGNOSTIC_TEST:** Blood test
- **DIAGNOSTIC_TEST:** Electrocardiogram
- **DIAGNOSTIC_TEST:** Accelerometery
- **DIAGNOSTIC_TEST:** 6 minute walk test (6MWT)
- **DIAGNOSTIC_TEST:** Skeletal muscle strength using handgrip strength and quadriceps (Cybex dynamometer)
- **OTHER:** Assessment of quality of life and heart failure symptoms
- **OTHER:** Assessment of sarcopenia
- **OTHER:** Assessment of frailty
- **OTHER:** Qualitative interview

## Key facts

- **NCT ID:** NCT05887271
- **Lead sponsor:** University of Leicester
- **Sponsor class:** OTHER
- **Phase:** PHASE2,PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2023-12-05
- **Primary completion:** 2026-05-31
- **Final completion:** 2026-05-31
- **Target enrollment:** 63 (ESTIMATED)
- **Last updated:** 2025-10-07

## Collaborators

- [object Object]
- [object Object]
- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05887271

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05887271, "A Randomised, Controlled Trial of a Low-energy Diet for Improving Functional Status in Heart Failure With PRESERVED Ejection Fraction Preserved Ejection Fraction". Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/clinical/NCT05887271. Licensed CC0.

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