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Could a Low-Calorie diet ease heart failure symptoms?

NCT ID NCT05887271

Disease control Sponsor: University of Leicester Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 23, 2026 · Updated 2 times

Summary

This study tests whether a 12-week low-calorie meal replacement diet can improve heart function and exercise ability in people with heart failure with preserved ejection fraction (HFpEF) who are also obese. 63 adults will be randomly assigned to either the diet or standard care. The main goal is to see if they can walk farther in a 6-minute walk test after 12 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
low-calorie meal replacement diet (850 kcal/day)
What this could lead to
If successful, this diet could become a simple, non-drug way to improve heart function and daily activity in people with heart failure and obesity.
What could go wrong
This is a small early-phase trial with only 63 participants, so results may not apply to everyone. The diet is very low in calories and may be hard to follow long-term.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

66 people

The number who actually took part.

Started

Dec 2023

Finished

Jun 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Established clinical diagnosis of heart failure with preserved ejection fraction HFpEF (EF\>45%) made by a cardiologist or a primary care physician with heart failure expertise, or a heart failure nurse 2. Clinically stable for ≥ 3 months (no admissions to hospital) 3. Obesity (BMI ≥30kg/m2 if white European or ≥27kg/m2 if Asian, Middle Eastern or Black ethnicity) 4. Age ≥18 Exclusion Criteria: 1. Inability to walk/undertake 6-minute walk test 2. Inability to follow a low-energy MRP 3. HFpEF due to infiltrative cardiomyopathy (cardiac amyloidosis or sarcoidosis), genetic hypertrophic cardiomyopathy, restrictive cardiomyopathy/pericardial disease or congenital heart disease. 4. Recovered EF (previous EF \< 40%) unless reduced EF was in context of tachycardia induced cardiomyopathy (eg AF/Aflutter). 5. Known heritable, idiopathic or drug-induced pulmonary arterial hypertension 6. Severe chronic obstructive pulmonary disease (FEV1\< 1.0L) 7. Severe primary valvular heart disease 8. Anaemia (Hb\<100g/L) 9. Severe renal disease (eGFR \< 30 ml/min/1.73 m2) 10. Weight loss \> 5kg in preceding 3 months. 11. Symptomatic gallstones (including biliary colic) or cholecystitis within last 3 months 12. Active substance abuse (drugs or alcohol) 13. History of bariatric surgery in the last 3 years 14. Active illness likely to cause change in weight 15. Women who are pregnant or are considering pregnancy 16. People currently participating in another clinical research trial that is likely to affect diet or weight change. 17. History of a severe mental illness including an eating disorder 17\. Individuals with a diagnosis of Type 1 diabetes mellitus.

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Conditions

The condition(s) this trial relates to.

diastolic heart failure Obesity obesity disorder type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes mellitus type 2 Diabetes mellitus type 2 in obese Heart failure with preserved ejection fraction Heart failure, diastolic Obesity adult onset

Contacts and locations

Locations

  • University of Leicester, Glenfield Hospital, Groby Road

    Leicester, Leicestershire, LE3 9QP, United Kingdom

  • University of Manchester, Wythenshawe Hospital, Southmoor Road

    Manchester, M23 9LT, United Kingdom

  • University of Oxford, John Radcliffe Hospital, Headley Way

    Oxford, OX3 9DU, United Kingdom

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