Effect of peanut butter supplementation on physical and cognitive functions in community-dwelling older adults: study protocol for a 6-month randomised controlled trial.
- 2024-09
- BMJ open 14(9)
- Jeew Hettiarachchi
- Ilili Feyesa
- Robin M Daly
- Elena S George
- Ekavi N Georgousopoulou
- David Scott
- Brenton J Baguley
- Sze-Yen Tan
- PubMed: 39242158
- DOI: 10.1136/bmjopen-2024-086232
Study Design
- Type
- Randomized Controlled Trial (RCT)
- Sample size
- n = 120
- Population
- 120 participants aged ≥65 years
- Methods
- randomised controlled trial, 43 g/day of peanut butter for 6 months versus habitual diet
- Blinding
- Open-label
- Duration
- 6 months
- Funding
- Unclear
- Large Human Trial
Introduction
Ageing is associated with physical and cognitive declines, which may be further exacerbated by poor nutrition. Nuts are energy and nutrient dense, and their consumption is associated with better physical and cognitive functions in older adults, but data from interventional studies are limited. This 6-month randomised controlled trial is designed to investigate the effects of consuming 43 g/day of peanut butter (equivalent to 1.5 servings of nuts) on physical function, including walking speed (primary outcome), standing and dynamic balance, upper and lower body strength, lower body power and endurance, and associated factors including muscle mass, cognitive function and DNA telomere length in community-dwelling older adults.Method and analysis
A total of 120 participants aged ≥65 years will be recruited and randomly allocated (1:1 ratio) to either the intervention group (n=60) that will receive individually packaged sealed containers containing 43 g of peanut butter to be consumed once daily for 6 months alongside habitual diet, or the control group (n=60) that will maintain their habitual diet. Primary and secondary outcomes will be assessed at baseline and at 6 months. The primary outcome is walking speed assessed using the 4 m usual gait speed test. Secondary outcomes include other physical function assessments: standing balance, chair stand time, timed-up-and-go test and four-square step test; and hand grip and knee extensor muscle strength; cognitive function assessed using the Montreal Cognitive Assessment and trail making tests; body composition; nutritional status; and DNA telomere length from participants' buccal cell samples. Linear mixed models will be used to compare changes in outcomes between intervention and control groups.Ethics and dissemination
The study protocol is approved by the Deakin University Human Research Ethics Committee. The trial is registered with the Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12622001291774. The results will be disseminated through peer-reviewed journals, conference presentations and media.Trial registration number
ANZCTR12622001291774.Research Insights
Secondary outcomes include ... body composition; nutritional status; and DNA telomere length
- Effect
- Neutral
- Effect size
- Small
- Dose
- 43 g/day
Secondary outcomes include ... cognitive function assessed using the Montreal Cognitive Assessment and trail making tests
- Effect
- Neutral
- Effect size
- Small
- Dose
- 43 g/day
Secondary outcomes include other physical function assessments: standing balance, chair stand time, timed-up-and-go test and four-square step test
- Effect
- Neutral
- Effect size
- Small
- Dose
- 43 g/day
Secondary outcomes include ... lower body power and endurance
- Effect
- Neutral
- Effect size
- Small
- Dose
- 43 g/day
Secondary outcomes include ... lower body power and endurance
- Effect
- Neutral
- Effect size
- Small
- Dose
- 43 g/day
Secondary outcomes include ... knee extensor muscle strength
- Effect
- Neutral
- Effect size
- Small
- Dose
- 43 g/day
Secondary outcomes include ... nutritional status; and DNA telomere length
- Effect
- Neutral
- Effect size
- Small
- Dose
- 43 g/day
Secondary outcomes include other physical function assessments: standing balance, chair stand time, timed-up-and-go test and four-square step test
- Effect
- Neutral
- Effect size
- Small
- Dose
- 43 g/day
Secondary outcomes include ... hand grip ... muscle strength
- Effect
- Neutral
- Effect size
- Small
- Dose
- 43 g/day
This 6-month randomised controlled trial is designed to investigate the effects of consuming 43 g/day of peanut butter ... on physical function, including walking speed (primary outcome)
- Effect
- Neutral
- Effect size
- Small
- Dose
- 43 g/day
Secondary outcomes include ... DNA telomere length from participants' buccal cell samples.
- Effect
- Neutral
- Effect size
- Small
- Dose
- 43 g/day