Coronary Heart DiseaseNCT04999358
Protein Intake in Patients With Coronary Heart Disease
A study testing Protein education and Standard education in people with Coronary Heart Disease and Low Protein Intake, run by Northumbria University at 1 site in United Kingdom.
Trial summary
Sarcopenia is a skeletal muscle disease, characterised by low muscle strength and muscle mass, and associated with higher medical care costs, shorter life expectancy and physical dependence. Sarcopenia affects around 1 in 10 older adults in the general population. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Coronary Heart Disease, Low Protein Intake, Sarcopenia
- What is being tested?
- Protein education and Standard education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Nov 2021to 12 Sep 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 50 years or older.
- Recent diagnosis of coronary heart disease or a cardiac event related to coronary heart disease.
- Have been offered standard cardiac rehabilitation in a Newcastle upon Tyne Hospitals NHS Foundation Trust.
- Usually receive dietary education as part of their cardiac rehabilitation program.
- Able to understand and undertake the tasks described as part of this study.
- Able to provide written informed consent.
Who cannot join
- Patients advised against participation in light exercise by a medical professional.
- Patients younger than 50 years.
- Patients unable to alter their diet due to medical reasons; including patients that have been prescribed artificial feeding, texture modified diets, and specialist renal diets.
- Patients with known stage 4 or 5 chronic kidney disease.
- Patients without access to teleconferencing technology or without another adult present (≥18 years; and with capacity to supervise the activity) will be excluded from participating in the remote sit-to-stand test for their safety.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Newcastle upon Tyne Hospitals NHS Trust
Newcastle upon Tyne, NE7 7DN
About this study
Official title: The Effectiveness of a Targeted Protein Education Telehealth Intervention to Increase Protein Intake in Patients With Coronary Heart Disease and Low Protein Intake: A Pilot Study
Sarcopenia is a skeletal muscle disease, characterised by low muscle strength and muscle mass, and associated with higher medical care costs, shorter life expectancy and physical dependence. Sarcopenia affects around 1 in 10 older adults in the general population. However, in patients with coronary heart disease (CHD), this number is almost 3 in 10. Patients who have CHD are offered cardiac rehabilitation (CR); a multicomponent programme designed to improve long-term health outcomes. Nutritional education is an important part of CR and typically focuses around modifying fat and carbohydrate intake to lower cholesterol levels and achieve a healthy weight. Currently there is little focus on increasing protein intake, which might reduce the risk of sarcopenia. Eligible patients with CHD and low protein intake will receive the standard nutritional education delivered during CR. Next, participants will be randomised to one of two groups: protein education (intervention), or standard information (control). Whilst COVID-19 restrictions are in place, education will be delivered remotely via pre-recorded video. Outcome measures, including protein intake, sit to stand performance, sarcopenia risk score (modified SARC-F), Physical Activity Vital Signs (PAVS) and waist circumference, will be assessed at baseline, at the end of the standard CR programme and after a follow-up period of the same duration as the CR programme.
- Conditions
- Coronary Heart Disease, Low Protein Intake, Sarcopenia
- Being tested
- Protein education, Standard education
- Keywords
- Protein, Coronary heart disease, Rehabilitation, Telehealth
- Medical subject headings
- Coronary Disease, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein educationBehavioural
The protein education session is pre-recorded and will describe in lay terms: the health issues associated with low protein intake, the amount of protein to eat in a day, and provide useful information to increase protein intake. This information will focus on the quality and amount of protein eaten, primarily using a whole-food approach. For example, the education sessions will give ideas for everyday foods that can be added to regular meals, favouring plant proteins, fish, lean meat, poultry, low fat dairy and eggs. The education session has been provided in conjunction with an NHS dietitian.
Standard educationBehavioural
Dietary advice provided as part of standard cardiac rehabilitation will be pre-recorded and provided to the control group. This education session will be in addition to usual care.
| Study group | Role | What they receive |
|---|---|---|
| Protein group | Experimental | Participants in the protein group will receive their usual education session(s) as part of standard practice cardiac rehabilitation. The session(s) will be the same for both study arms and will align with the dietary education sessions that these patients would usually be given during their normal cardiac rehabilitation programme. Participants in the protein group will be provided with an additional targeted protein education session, which will aim to increase the amount of foods eaten with protein in them (≥1.2 g/kg protein/day) and improve the quality of protein sources that are eaten. The content and materials for these sessions can be provided in-person or are available as pre-recorded videos, accessed by participants via the internet or DVD Receives: Behavioral: Protein education |
| Control group | Placebo comparator | Participants in the control group will receive their usual education session(s) as part of standard practice cardiac rehabilitation. The session(s) will be the same for both study arms and will align with the dietary education sessions that these patients would usually be given during their normal cardiac rehabilitation programme. Participants in the control group will receive an additional dietary education session that is similar to the standard practice sessions, containing only information that is usually provided in the cardiac rehabilitation programme.The content and materials for these sessions can be provided in-person or are available as pre-recorded videos, accessed by participants via the internet or DVD. Receives: Behavioral: Standard education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in protein intake (g/kg/day).
Between-group intervention effect for dietary protein intake in the intervention and control groups. Protein intake is assessed with a three-day food diary.
Measured: Up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.
Secondary outcomes (10)
Prevalence of low protein intake in patients with coronary heart disease.
Average protein intake and percentage of participants with protein intake <1.2 g/kg/day and <0.8 g/kg/day.
Measured: Baseline, up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.
Change in sit to stand performance (leg strength).
Between-group intervention effect for sit to stand performance in the intervention and control groups. The time taken to complete five consecutive sit to stands will be recorded.
Measured: Up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.
Change in sarcopenia risk score and self-reported physical activity.
Between-group intervention effect for questionnaire scores in the intervention and control groups. Sarcopenia risk and physical activity are assessed using the modified SARC-F questionnaire (SARC-F+EBM; includes age and body mass index) and Physical Activity Vital Signs questionnaire (PAVS), respectively.
Measured: Up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.
Difference in protein intake between patients with and without probable sarcopenia.
Probable sarcopenia is assessed using sit to stand time. The cut-off point for probable sarcopenia will be >15seconds to complete five sit to stands, as proposed by the European Working Group on Sarcopenia in Older People-2.
Measured: Baseline, up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.
Change in waist circumference.
Between-group intervention effect for waist circumference will be assessed as a simple indicator of body composition.
Measured: Up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.
Reliability of self-assessed waist circumference.
Whilst COVID-19 restrictions are in place, participants will be required to complete their own waist circumference measurement. Measures will be taken 24 hours apart to determine their reliability.
Measured: 24 hours.
Adherence
Adherence will be assessed as the amount of education sessions completed by participants, as a percentage of those prescribed.
Measured: Up to 12 weeks.
Attrition.
Attrition will be assessed as the percentage of participants that drop out of the intervention before the study period is complete.
Measured: Up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.
Occurrence of adverse events
Adverse events (such as injury or illness) that are directly related to the intervention will be reported..
Measured: Up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.
Understanding and evaluation of the intervention.
A short questionnaire will determine patients' understanding of the educational material and their evaluation of the intervention
Measured: Baseline and up to 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study start29 Nov 2021
- Primary completion12 Sep 2023
- Study completion12 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single centre, parallel-group, two arm, randomised controlled trial.
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Collaborators
- Newcastle-upon-Tyne Hospitals NHS Trust
- Responsible party
- Principal investigator, Emily James, Northumbria University
- Investigators
- Alasdair O'Doherty, PhD, Study chair, University of Northumbria at Newcastle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04999358
- Sponsor's protocol ID
- 296288
- Status last verified
- Apr 2025
- First submitted
- 29 Jul 2021
- Last updated
- 9 Apr 2025
- 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 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Targeted Protein Education Telehealth Intervention to Increase Protein Intake in Patients With Coronary Heart Disease and Low Protein Intake: A Pilot Study
- ClinicalTrials.gov ID
- NCT04999358
- Acronym / sponsor ID
- 296288
- Conditions
- Coronary Heart Disease, Low Protein Intake, Sarcopenia
- Keywords
- Protein, Coronary heart disease, Rehabilitation, Telehealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Collaborators
- Newcastle-upon-Tyne Hospitals NHS Trust
- Study start
- 29 Nov 2021 (actual)
- Primary completion
- 12 Sep 2023 (actual)
- Study completion
- 12 Sep 2023 (actual)
- First posted
- 10 Aug 2021 (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.
Sarcopenia is a skeletal muscle disease, characterised by low muscle strength and muscle mass, and associated with higher medical care costs, shorter life expectancy and physical dependence. Sarcopenia affects around 1 in 10 older adults in the general population. However, in patients with coronary heart disease (CHD), this number is almost 3 in 10. Patients who have CHD are offered cardiac rehabilitation (CR); a multicomponent programme designed to improve long-term health outcomes. Nutritional education is an important part of CR and typically focuses around modifying fat and carbohydrate intake to lower cholesterol levels and achieve a healthy weight. Currently there is little focus on increasing protein intake, which might reduce the risk of sarcopenia. Eligible patients with CHD and low protein intake will receive the standard nutritional education delivered during CR. Next, participants will be randomised to one of two groups: protein education (intervention), or standard information (control). Whilst COVID-19 restrictions are in place, education will be delivered remotely via pre-recorded video. Outcome measures, including protein intake, sit to stand performance, sarcopenia risk score (modified SARC-F), Physical Activity Vital Signs (PAVS) and waist circumference, will be assessed at baseline, at the end of the standard CR programme and after a follow-up period of the same duration as the CR programme.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a single centre, parallel-group, two arm, randomised controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Protein group | Experimental | Behavioral: Protein educationParticipants in the protein group will receive their usual education session(s) as part of standard practice cardiac rehabilitation. The session(s) will be the same for both study arms and will align with the dietary education sessions that these patients would usually be given during their normal cardiac rehabilitation programme. Participants in the protein group will be provided with an additional targeted protein education session, which will aim to increase the amount of foods eaten with protein in them (≥1.2 g/kg protein/day) and improve the quality of protein sources that are eaten. The content and materials for these sessions can be provided in-person or are available as pre-recorded videos, accessed by participants via the internet or DVD |
| Control group | Placebo comparator | Behavioral: Standard educationParticipants in the control group will receive their usual education session(s) as part of standard practice cardiac rehabilitation. The session(s) will be the same for both study arms and will align with the dietary education sessions that these patients would usually be given during their normal cardiac rehabilitation programme. Participants in the control group will receive an additional dietary education session that is similar to the standard practice sessions, containing only information that is usually provided in the cardiac rehabilitation programme.The content and materials for these sessions can be provided in-person or are available as pre-recorded videos, accessed by participants via the internet or DVD. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 50 years or older.
- Recent diagnosis of coronary heart disease or a cardiac event related to coronary heart disease.
- Have been offered standard cardiac rehabilitation in a Newcastle upon Tyne Hospitals NHS Foundation Trust.
- Usually receive dietary education as part of their cardiac rehabilitation program.
- Able to understand and undertake the tasks described as part of this study.
Key exclusion criteria (5 listed)
- Patients advised against participation in light exercise by a medical professional.
- Patients younger than 50 years.
- Patients unable to alter their diet due to medical reasons; including patients that have been prescribed artificial feeding, texture modified diets, and specialist renal diets.
- Patients with known stage 4 or 5 chronic kidney disease.
- Patients without access to teleconferencing technology or without another adult present (≥18 years; and with capacity to supervise the activity) will be excluded from participating in the remote sit-to-stand test for their safety.
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 |
|---|---|---|
| Protein educationThe protein education session is pre-recorded and will describe in lay terms: the health issues associated with low protein intake, the amount of protein to eat in a day, and provide useful information to increase protein intake. This information will focus on the quality and amount of protein eaten, primarily using a whole-food approach. For example, the education sessions will give ideas for everyday foods that can be added to regular meals, favouring plant proteins, fish, lean meat, poultry, low fat dairy and eggs. The education session has been provided in conjunction with an NHS dietitian. | Behavioural | Protein group |
| Standard educationDietary advice provided as part of standard cardiac rehabilitation will be pre-recorded and provided to the control group. This education session will be in addition to usual care. | Behavioural | Control group |
Primary outcome
Change in protein intake (g/kg/day).
Time frame: Up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.
Between-group intervention effect for dietary protein intake in the intervention and control groups. Protein intake is assessed with a three-day food diary.
10 secondary outcomes
Prevalence of low protein intake in patients with coronary heart disease.
Time frame: Baseline, up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.
Change in sit to stand performance (leg strength).
Time frame: Up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.
Change in sarcopenia risk score and self-reported physical activity.
Time frame: Up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.
Difference in protein intake between patients with and without probable sarcopenia.
Time frame: Baseline, up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.
Change in waist circumference.
Time frame: Up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.
Reliability of self-assessed waist circumference.
Time frame: 24 hours.
Adherence
Time frame: Up to 12 weeks.
Attrition.
Time frame: Up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.
Occurrence of adverse events
Time frame: Up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.
Understanding and evaluation of the intervention.
Time frame: Baseline and up to 12 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- 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.
Alasdair O'Doherty, PhD study chair
University of Northumbria at Newcastle
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein education and Standard education in people with Coronary Heart Disease and Low Protein Intake, run by Northumbria University 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 9 Apr 2025. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in protein intake (g/kg/day). (time frame: Up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.). 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 9 Apr 2025.