Dietary ExposureALLEVIATENCT04173117
Feasibility of Low Energy Diet in HFpEF and Type 2 Diabetes
A study testing Low energy meal replacement plan (12 weeks) in people with Dietary Exposure, run by University of Leicester at 1 site in United Kingdom.
Trial summary
Open, Single arm intervention, feasibility study Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dietary Exposure
- What is being tested?
- Low energy meal replacement plan (12 weeks)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Feb 2020to 21 Apr 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Established T2D (HbA1c ≥6.5%, duration >3months)
- Obesity (BMI ≥30 or ≥27 kg/m2 if black/south Asian ethnicity)
- Symptoms limiting exercise capacity in normal daily activities (dyspnoea or fatigue) or an established diagnosis of HF
- Diagnosis of HFpEF in accordance with European Society of Cardiology criteria: LV EF >50% with objective evidence of cardiac structural or functional alterations (LV hypertrophy (≥12mm); LV mass index ≥115g/m2 for males and ≥95g/m2 for females; E/e' ≥13 and a mean e' septal and lateral wall <9 cm/s; left atrial volume index >34mL/m2 or reduced global longitudinal strain (>-18%); elevated levels of natriuretic peptides (B-type natriuretic peptide >35pg/mL and/or NT-pro B-type natriuretic peptide >125pg/mL))
Who cannot join
- Unwilling to undertake MRP (low energy diet)
- HBa1c >10%
- Diabetes duration >12 years
- High-dose insulin requirement: either on full basal-bolus insulin regime or insulin requirement >1U/kg/day
- Have been on insulin treatment >10 years
- Current treatment with anti-obesity drugs
Show all 17Show fewer
- Diagnosed eating disorder or purging
- Weight loss > 5kg in preceding 3 months (unless related to hospitalisation for HF)
- Absolute contraindications to MRI
- Severe renal impairment eGFR<30ml/min/m2
- Myocardial infarction within preceding 6 months
- History of substance abuse
- Cancer undergoing active treatment
- Unable to consent due to lack of mental capacity
- Pregnancy/considering pregnancy
- People unable to perform activities of daily living independently or unable attend for clinical appointments without a carer/attendant
- Unable to read/understand English sufficiently to provide informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cardiovascular Research Centre (Glenfield Hospital)
Leicester, Leicestershire, LE3 9QP
About this study
Official title: A Low-energy Meal Replacement Plan for Heart Failure With Preserved Ejection Fraction and Type 2 Diabetes: A Feasibility Study
Open, Single arm intervention, feasibility study
Read the detailed description
The aims of the proposed feasibility study are to assess whether a low-energy meal replacement plan (MRP) in patients with HFpEF and T2D:
- Is acceptable to an older, co-morbid, multi-ethnic population
The secondary objectives are to assess whether a low-energy MRP in patients with HFpEF and T2D may be:
- associated with improved symptoms
- likely to lead to favourable cardiovascular reverse remodelling
- likely to improve functional capacity and quality of life
- associated with favourable reductions in cardiovascular biomarkers
- associated with increased physical activity
- associated with favourable cardiovascular outcomes
All patients will undergo the following assessments at baseline, 12-weeks and 12 months (following MRP):
- Anthropometry: height, weight, BMI.
- Haemodynamics: resting heart rate and blood pressure.
- 6-minute walk test +/- cardiopulmonary exercise test (if able to perform)
- CMR: contrast enhanced, stress perfusion CMR
- MLWHFQ
- WHODAS 2.0 (12-item version)
- Fasting blood test: full blood count, urea and electrolytes, HbA1c, fasting glucose, BNP, high-sensitivity troponin I, insulin and C-peptide. Plasma (≈35mL) will be stored for future biomarker analysis including metabolomics.
- Urinalysis for proteinuria and urine protein/creatinine ratio.
- Body composition; dual-energy X-ray absorptiometry (DEXA) scanning.
- At the end of the 12-week intervention, participants will be invited to a semi-structured interview to explore qualitative aspects of the study to guide future trial design.
- At 12 months attendance at cardiac rehabilitation will be reviewed.
The MRP provided by Cambridge Weight Plan® contains ~810 kcal/day (30% protein, 50% carbohydrate, 20% fat). The diet will be stopped, and a maintenance diet re-introduced once 50% excess body weight has been lost, or by 12 weeks, whichever comes first.
- Conditions
- Dietary Exposure
- Being tested
- Low energy meal replacement plan (12 weeks)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low energy meal replacement plan (12 weeks)Dietary supplement
Low energy meal replacement plan (12 weeks)
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Low energy meal replacement plan 12 weeks Receives: Dietary Supplement: Low energy meal replacement plan (12 weeks) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment and retention rates
The number of people approached, recruited and retained
Measured: 16 weeks
Secondary outcomes (47)
Differences in 6 minute walk test pre- and post intervention
Meters walked within 6 minutes
Measured: 12 weeks
Differences in cardiopulmonary exercise test (peak VO2) pre- and post intervention
exercise test on a static bike using minute by minute ventilatory gas analysis
Measured: 12 weeks
Differences in LV remodelling (indexed LV mass) pre- and post intervention
CMR measures of cardiac geometry
Measured: 12 weeks
Differences in LV function pre- and post intervention
CMR measures of cardiac function
Measured: 12 weeks
Differences in E/A ratio pre- and post intervention
Standard clinical echocardiography
Measured: 12 weeks
Differences in E (cm/s) pre- and post intervention
Standard clinical echocardiography
Measured: 12 weeks
Differences in MV deceleration time (ms) pre- and post intervention
Standard clinical echocardiography
Measured: 12 weeks
Differences in A (cm/s) pre- and post intervention
Standard clinical echocardiography
Measured: 12 weeks
Differences in Septal e' pre- and post intervention
Standard clinical echocardiography
Measured: 12 weeks
Differences in Lateral e' pre- and post intervention
Standard clinical echocardiography
Measured: 12 weeks
Differences in Septal E/e' pre- and post intervention
Standard clinical echocardiography
Measured: 12 weeks
Differences in Lateral E/e' pre- and post intervention
Standard clinical echocardiography
Measured: 12 weeks
Differences in Average E/e' pre- and post intervention
Standard clinical echocardiography
Measured: 12 weeks
Differences in LA volume indexed pre- and post intervention
Standard clinical echocardiography
Measured: 12 weeks
Differences in TR jet velocity (m/s) pre- and post intervention
Standard clinical echocardiography
Measured: 12 weeks
Differences in BMI pre- and post intervention
Weighing scales and stadiometer measurement (Kg/m2)
Measured: 12 weeks
Differences in Bone Mineral Density (g/cm2) pre- and post intervention
DEXA scan
Measured: 12 weeks
Differences in Total Fat mass (g) pre- and post intervention
DEXA scan
Measured: 12 weeks
Differences in Total tissue fat (%) pre- and post intervention
DEXA scan
Measured: 12 weeks
Differences in visceral adipose tissue mass (g) pre- and post intervention
DEXA scan
Measured: 12 weeks
Differences in visceral adipose tissue volume (cm3) pre- and post intervention
DEXA scan
Measured: 12 weeks
Differences in Total lean body mass (g) pre- and post intervention
DEXA scan
Measured: 12 weeks
Difference in World Health Organisation Disability Schedule (WHODAS 2.0) pre- and post intervention
Scale 0 - 48 with lower scores indicating better outcome
Measured: 12 weeks
Difference in Medical Research Council Dyspnoea Scale pre- and post intervention
scale 1 - 5 with lower scores indicating better outcome
Measured: 12 weeks
Difference in Minnesota Living with heart Failure Questionnaire pre- and post intervention
Scale 0 - 105 with lower scores indicating better outcome
Measured: 12 weeks
Differences in Fasting Glucose (mmol/L) pre- and post intervention
Biochemistry
Measured: 12 weeks
Differences in HbA1c (%) pre- and post intervention
Biochemistry
Measured: 12 weeks
Differences in HbA1c (mmol/mol) pre- and post intervention
Biochemistry
Measured: 12 weeks
Differences in B-type (ng/L) natriuretic peptide pre- and post intervention
Biochemistry
Measured: 12 weeks
Differences in hs-troponin (ng/L) natriuretic peptide pre- and post intervention
Biochemistry
Measured: 12 weeks
Differences in CRP (mg/L), natriuretic peptide pre- and post intervention
Biochemistry
Measured: 12 weeks
Differences in albumin concentration pre- and post intervention
Biochemistry
Measured: 12 weeks
Differences in albumin/creatinine ratio concentration pre- and post intervention
Biochemistry
Measured: 12 weeks
Differences in sodium (mmol/L) pre- and post intervention
Biochemistry
Measured: 12 weeks
Differences in potassium (mmol/L) pre- and post intervention
Biochemistry
Measured: 12 weeks
Differences in Urea (mmol/L) pre- and post intervention
Biochemistry
Measured: 12 weeks
Differences in creatinine (umol/L) pre- and post intervention
Biochemistry
Measured: 12 weeks
Differences in eGFR (ml/min) pre- and post intervention
Biochemistry
Measured: 12 weeks
Differences in hsTnl(ng/L) pre- and post intervention
Biochemistry
Measured: 12 weeks
Differences in hALT (iu/L) pre- and post intervention
Biochemistry
Measured: 12 weeks
Differences in ALP (iu/L)pre- and post intervention
Biochemistry
Measured: 12 weeks
Differences in LDL (mmol/L) pre- and post intervention
Biochemistry
Measured: 12 weeks
Differences in kidney function pre- and post intervention
Blood analysis for eGFR (ml/min)
Measured: 12 weeks
Differences in liver function pre- and post intervention
Blood analysis for ALP (iu/L)
Measured: 12 weeks
Differences in the levels of physical activity pre- and post intervention
Objectively measured with an accelerometer
Measured: 12 weeks
Cardiac rehabilitation uptake
The proportion of participants who were offered and attended cardiac rehabilitation following completion of the intervention (%)
Measured: 12 months
The number of participants who experience any Major Adverse Cardiovascular Events (MACE)
At any point during the study if a participant experiences a major cardiovascular event this will be recorded and reported to sponsor in line with handling serious adverse events
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start28 Feb 2020
- Primary completion21 Apr 2023
- Study completion21 Apr 2023
Why it stopped: Major delays attributed to COVID-19 pandemic. Learnings informed design of multi-centre RCT
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary ExposureStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Low energy meal replacement plan for 12 weeks
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04173117
- Sponsor's protocol ID
- 0699
- Acronym
- ALLEVIATE
- Status last verified
- May 2022
- First submitted
- 8 Nov 2019
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- 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 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Low-energy Meal Replacement Plan for Heart Failure With Preserved Ejection Fraction and Type 2 Diabetes: A Feasibility Study
- ClinicalTrials.gov ID
- NCT04173117
- Acronym / sponsor ID
- ALLEVIATE / 0699
- Conditions
- Dietary Exposure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Major delays attributed to COVID-19 pandemic. Learnings informed design of multi-centre RCT
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Study start
- 28 Feb 2020 (actual)
- Primary completion
- 21 Apr 2023 (actual)
- Study completion
- 21 Apr 2023 (actual)
- First posted
- 21 Nov 2019 (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.
Open, Single arm intervention, feasibility study
Detailed description
The aims of the proposed feasibility study are to assess whether a low-energy meal replacement plan (MRP) in patients with HFpEF and T2D:
- Is acceptable to an older, co-morbid, multi-ethnic population
The secondary objectives are to assess whether a low-energy MRP in patients with HFpEF and T2D may be:
- associated with improved symptoms
- likely to lead to favourable cardiovascular reverse remodelling
- likely to improve functional capacity and quality of life
- associated with favourable reductions in cardiovascular biomarkers
- associated with increased physical activity
- associated with favourable cardiovascular outcomes
All patients will undergo the following assessments at baseline, 12-weeks and 12 months (following MRP):
- Anthropometry: height, weight, BMI.
- Haemodynamics: resting heart rate and blood pressure.
- 6-minute walk test +/- cardiopulmonary exercise test (if able to perform)
- CMR: contrast enhanced, stress perfusion CMR
- MLWHFQ
- WHODAS 2.0 (12-item version)
- Fasting blood test: full blood count, urea and electrolytes, HbA1c, fasting glucose, BNP, high-sensitivity troponin I, insulin and C-peptide. Plasma (≈35mL) will be stored for future biomarker analysis including metabolomics.
- Urinalysis for proteinuria and urine protein/creatinine ratio.
- Body composition; dual-energy X-ray absorptiometry (DEXA) scanning.
- At the end of the 12-week intervention, participants will be invited to a semi-structured interview to explore qualitative aspects of the study to guide future trial design.
- At 12 months attendance at cardiac rehabilitation will be reviewed.
The MRP provided by Cambridge Weight Plan® contains ~810 kcal/day (30% protein, 50% carbohydrate, 20% fat). The diet will be stopped, and a maintenance diet re-introduced once 50% excess body weight has been lost, or by 12 weeks, whichever comes first.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Low energy meal replacement plan for 12 weeks
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: Low energy meal replacement plan (12 weeks)Low energy meal replacement plan 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Established T2D (HbA1c ≥6.5%, duration >3months)
- Obesity (BMI ≥30 or ≥27 kg/m2 if black/south Asian ethnicity)
- Symptoms limiting exercise capacity in normal daily activities (dyspnoea or fatigue) or an established diagnosis of HF
- Diagnosis of HFpEF in accordance with European Society of Cardiology criteria: LV EF >50% with objective evidence of cardiac structural or functional alterations (LV hypertrophy (≥12mm); LV mass index ≥115g/m2 for males and ≥95g/m2 for females; E/e' ≥13 and a mean e' septal and lateral wall <9 cm/s; left atrial volume index >34mL/m2 or reduced global longitudinal strain (>-18%); elevated levels of natriuretic peptides (B-type natriuretic peptide >35pg/mL and/or NT-pro B-type natriuretic peptide >125pg/mL))
Key exclusion criteria (17 listed)
- Unwilling to undertake MRP (low energy diet)
- HBa1c >10%
- Diabetes duration >12 years
- High-dose insulin requirement: either on full basal-bolus insulin regime or insulin requirement >1U/kg/day
- Have been on insulin treatment >10 years
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 |
|---|---|---|
| Low energy meal replacement plan (12 weeks)Low energy meal replacement plan (12 weeks) | Dietary supplement | Intervention |
Primary outcome
Recruitment and retention rates
Time frame: 16 weeks
The number of people approached, recruited and retained
47 secondary outcomes
Differences in 6 minute walk test pre- and post intervention
Time frame: 12 weeks
Differences in cardiopulmonary exercise test (peak VO2) pre- and post intervention
Time frame: 12 weeks
Differences in LV remodelling (indexed LV mass) pre- and post intervention
Time frame: 12 weeks
Differences in LV function pre- and post intervention
Time frame: 12 weeks
Differences in E/A ratio pre- and post intervention
Time frame: 12 weeks
Differences in E (cm/s) pre- and post intervention
Time frame: 12 weeks
Differences in MV deceleration time (ms) pre- and post intervention
Time frame: 12 weeks
Differences in A (cm/s) pre- and post intervention
Time frame: 12 weeks
Differences in Septal e' pre- and post intervention
Time frame: 12 weeks
Differences in Lateral e' pre- and post intervention
Time frame: 12 weeks
Differences in Septal E/e' pre- and post intervention
Time frame: 12 weeks
Differences in Lateral E/e' pre- and post intervention
Time frame: 12 weeks
Differences in Average E/e' pre- and post intervention
Time frame: 12 weeks
Differences in LA volume indexed pre- and post intervention
Time frame: 12 weeks
Differences in TR jet velocity (m/s) pre- and post intervention
Time frame: 12 weeks
Differences in BMI pre- and post intervention
Time frame: 12 weeks
Differences in Bone Mineral Density (g/cm2) pre- and post intervention
Time frame: 12 weeks
Differences in Total Fat mass (g) pre- and post intervention
Time frame: 12 weeks
Differences in Total tissue fat (%) pre- and post intervention
Time frame: 12 weeks
Differences in visceral adipose tissue mass (g) pre- and post intervention
Time frame: 12 weeks
Differences in visceral adipose tissue volume (cm3) pre- and post intervention
Time frame: 12 weeks
Differences in Total lean body mass (g) pre- and post intervention
Time frame: 12 weeks
Difference in World Health Organisation Disability Schedule (WHODAS 2.0) pre- and post intervention
Time frame: 12 weeks
Difference in Medical Research Council Dyspnoea Scale pre- and post intervention
Time frame: 12 weeks
Difference in Minnesota Living with heart Failure Questionnaire pre- and post intervention
Time frame: 12 weeks
Differences in Fasting Glucose (mmol/L) pre- and post intervention
Time frame: 12 weeks
Differences in HbA1c (%) pre- and post intervention
Time frame: 12 weeks
Differences in HbA1c (mmol/mol) pre- and post intervention
Time frame: 12 weeks
Differences in B-type (ng/L) natriuretic peptide pre- and post intervention
Time frame: 12 weeks
Differences in hs-troponin (ng/L) natriuretic peptide pre- and post intervention
Time frame: 12 weeks
Differences in CRP (mg/L), natriuretic peptide pre- and post intervention
Time frame: 12 weeks
Differences in albumin concentration pre- and post intervention
Time frame: 12 weeks
Differences in albumin/creatinine ratio concentration pre- and post intervention
Time frame: 12 weeks
Differences in sodium (mmol/L) pre- and post intervention
Time frame: 12 weeks
Differences in potassium (mmol/L) pre- and post intervention
Time frame: 12 weeks
Differences in Urea (mmol/L) pre- and post intervention
Time frame: 12 weeks
Differences in creatinine (umol/L) pre- and post intervention
Time frame: 12 weeks
Differences in eGFR (ml/min) pre- and post intervention
Time frame: 12 weeks
Differences in hsTnl(ng/L) pre- and post intervention
Time frame: 12 weeks
Differences in hALT (iu/L) pre- and post intervention
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Major delays attributed to COVID-19 pandemic. Learnings informed design of multi-centre RCT). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low energy meal replacement plan (12 weeks) in people with Dietary Exposure, run by University of Leicester at 1 site in United Kingdom.
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 17 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: stopped early, as of the sponsor's last update on 28 Apr 2023. 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 United Kingdom. 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. 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?
The study was stopped early (reason given: Major delays attributed to COVID-19 pandemic. Learnings informed design of multi-centre RCT). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment and retention rates (time frame: 16 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 28 Apr 2023.