Protein Intake in Patients With Coronary Heart Disease

NCT04999358 | Completed

• 1 other identifier: 296288
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Heart Disease; Low Protein Intake; Sarcopenia

Keywords

Protein; Coronary heart disease; Rehabilitation; Telehealth

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  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).

  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.

  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.

  Baseline, up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.

• Change in waist circumference.

  Up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.

Study Arms (2)

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

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.

Behavioral: Standard education

Interventions

Protein education BEHAVIORAL

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.

Protein group

Standard education BEHAVIORAL

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.

Control group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northumbria University: lead
• Newcastle-upon-Tyne Hospitals NHS Trust: collaborator

Study Sites (1)

Newcastle upon Tyne Hospitals NHS Trust

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

MeSH Terms

Conditions

Coronary Disease; Sarcopenia

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Alasdair O'Doherty, PhD

  University of Northumbria at Newcastle

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a single centre, parallel-group, two arm, randomised controlled trial.

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: August 10, 2021
• Study Start: November 29, 2021
• Primary Completion: September 12, 2023
• Study Completion: September 12, 2023
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)