Protein Intake in Patients With Coronary Heart Disease

Not Applicable

Completed

• Conditions: Sarcopenia; Coronary Heart Disease; Low Protein Intake

• Registration Number: NCT04999358
• Lead Sponsor: Northumbria University

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-29
• Study First Submitted QC: 2021-08-05
• Study First Posted: 2021-08-10
• Study Start: 2021-11-29
• Primary Completion: 2023-09-12
• Study Completion: 2023-09-12
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in protein intake (g/kg/day).	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.

Secondary Outcome Measures

Name	Time	Method
Change in sit to stand performance (leg strength).	Up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.	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.
Change in waist circumference.	Up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.	Between-group intervention effect for waist circumference will be assessed as a simple indicator of body composition.
Reliability of self-assessed waist circumference.	24 hours.	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.
Attrition.	Up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.	Attrition will be assessed as the percentage of participants that drop out of the intervention before the study period is complete.
Occurrence of adverse events	Up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.	Adverse events (such as injury or illness) that are directly related to the intervention will be reported..
Prevalence of low protein intake in patients with coronary heart disease.	Baseline, up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.	Average protein intake and percentage of participants with protein intake \<1.2 g/kg/day and \<0.8 g/kg/day.
Understanding and evaluation of the intervention.	Baseline and up to 12 weeks.	A short questionnaire will determine patients' understanding of the educational material and their evaluation of the intervention
Change in sarcopenia risk score and self-reported physical activity.	Up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.	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.
Difference in protein intake between patients with and without probable sarcopenia.	Baseline, up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.	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.
Adherence	Up to 12 weeks.	Adherence will be assessed as the amount of education sessions completed by participants, as a percentage of those prescribed.

Trial Locations

Locations (1)

Newcastle upon Tyne Hospitals NHS Trust; 🇬🇧 Newcastle Upon Tyne, United Kingdom