Protein Intake in Patients With Coronary Heart Disease

Northumbria University

Status: Completed

Conditions: Low Protein Intake; Coronary Heart Disease; Sarcopenia

Treatments: Behavioral: Standard education; Behavioral: Protein education

Study type: Interventional

Funder types: Other

Identifiers

NCT04999358

296288

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

35 participants in 2 patient groups, including a placebo group

Protein group

Experimental group

Description:

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

Treatment:

Behavioral: Protein education

Control group

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Standard education