Effectiveness of a ReMIND Diet Intervention on Sarcopenia, Cognitive Frailty and Nutritional Status in Older Adults

University of Putra Malaysia (UPM)

Status: Begins enrollment in 2 months

Conditions: Nutritional Interventions; Cognitive Frailty; Sarcopenia

Treatments: Other: PPR Seri Alam Fasa 2 (Intervention Group)

Study type: Interventional

Funder types: Other

Identifiers

NCT07325760

JKEUPM-2025-383

Details and patient eligibility

About

This research is a single-blinded, 12-week, two-arm cluster randomized controlled trial to evaluate the effectiveness of a Malaysian-adapted MIND (Mediterranean-DASH Intervention for Neurodegenerative Delay) diet retort meal intervention on sarcopenia risk, cognitive frailty status, nutritional status, depression, functional ability, and food security among older adults in Malaysia. With Malaysia projected to become an aged society by 2030, addressing age-related health challenges, including cognitive frailty and sarcopenia, is a national priority. Current evidence indicates that poor diet quality and food insecurity among older adults, especially those in low-income urban communities, exacerbate these conditions. The study is grounded on the Meals on Wheels (MoW) program, which has been effective in reducing malnutrition among older populations globally but is limited in scalability due to high delivery costs. Retort meals which are shelf-stable and nutritionally balanced offer a feasible alternative for meal provision in poor urban settings. The MIND diet, originally designed to support brain health, also demonstrates benefits for muscle health and overall physical function. However, its adaptation to the Malaysian context is crucial due to cultural dietary preferences and cost barriers to certain ingredients. The intervention will recruit 70 older adults (aged 60-84 years) from Program Perumahan Rakyat (PPR) Seri Alam Fasa 2 and Perumahan Awam (PA) Loke Yew in Kuala Lumpur, classified under the B40 income group and at risk of food insecurity. The intervention group will receive retort meals designed according to the adapted MIND diet principles, while the control group will not receive intervention. Data will be collected at baseline, 6 weeks, and 12 weeks to assess outcomes in muscle health, cognitive frailty, nutritional status, depression, functional ability, food security, and cost-effectiveness. Overall, the conceptual framework provides a structured approach to understanding how the intervention contributes to improved nutritional well-being and supports the economic viability of the Meals on Wheels program. Potential confounding variables, including socioeconomic status, baseline health conditions, social support, and lifestyle factors, may also influence the outcomes. Participants will fill up a questionnaire regarding their sociodemographic characteristics, medical factors, psychological factors, lifestyle factors, food security status, functional ability, and depression status. Besides, the researcher will conduct face-to-face interviews to collect data regarding anthropometric measurements, handgrip strength, medical costs, and diet history. Statistical analyses will employ mixed-effects models to evaluate both continuous and categorical outcomes over time. The findings will generate crucial evidence on the feasibility, effectiveness, and cost-efficiency of using retort meals within MoW programs in Malaysia. Furthermore, it will inform national strategies to address food insecurity, promote healthy ageing, and reduce the burden of age-related health conditions. With Malaysia's rapidly ageing population and increasing prevalence of sarcopenia and cognitive frailty, this study has the potential to shape policy and practice by offering a sustainable, culturally tailored nutrition intervention. The evidence derived will support the scaling up of MoW programs using retort meals and contribute to long-term solutions for improving the quality of life and independence of older adults in Malaysia.

Full description

Background:

Global population ageing is accelerating, with adults aged ≥60 years expected to reach 2.1 billion by 2050. Malaysia is projected to become an aged nation by 2030, when more than 15% of the population will be older adults. Ageing is associated with increased risks of chronic diseases, frailty, sarcopenia, and cognitive decline, contributing to reduced independence and quality of life. Nutrition plays a key protective role in mitigating these risks.

The MIND diet integrates principles from the Mediterranean and DASH dietary patterns and emphasizes leafy green vegetables, whole grains, legumes, nuts, fish, and limited intake of saturated fats and refined foods. Its Malaysian adaptation, MY-MINDD, incorporates culturally relevant foods, locally available fruits, soy-based products, and regionally preferred fish while excluding alcohol-based components. Previous local findings indicate that adherence to MY-MINDD is associated with improved cognitive outcomes in older adults.

Despite these benefits, poor diet quality, high reliance on eating-out patterns, and food insecurity remain prevalent among Malaysian older adults, especially among low-income urban communities. Approximately one-third of older adults in Malaysia are malnourished, and rising living costs further restrict access to nutritious foods. MoW programs offer support to food-insecure older adults but often face logistical, financial, and sustainability challenges. Integrating MY-MINDD principles into MoW through shelf-stable retort meals may enhance dietary access, improve nutritional status, and reduce risks of sarcopenia and cognitive frailty among vulnerable older adults.

Problem Statement and Rationale:

Evidence evaluating MoW programs in Malaysia remains limited, and no studies have assessed the feasibility, cost-effectiveness, or health impact of providing MIND-based retort meals within MoW delivery systems. The MIND diet has shown potential for improving diet quality, elevating neuroprotective biomarkers, and reducing risks of sarcopenia and cognitive decline; however, local implementation and evaluation remain scarce. Cultural adaptations are essential to ensure relevance in the Malaysian context.

This study addresses these evidence gaps by examining the effectiveness and cost-efficiency of integrating MY-MINDD-based retort meals into MoW programs. The investigation focuses on sarcopenia, cognitive frailty, nutritional status, depression, functional ability, and food security among economically deprived older adults.

Significance of the Study:

The intervention aligns with national guidelines emphasizing the provision of safe, nutritionally balanced, and culturally appropriate meals for vulnerable populations. The use of retort meals supports food safety, reduces logistical burdens, and enhances accessibility for older adults living in urban low-income environments. By targeting the unique challenges faced by the urban poor, such as higher food prices and limited mobility, the study contributes to national efforts to reduce food insecurity and promote healthy ageing.

Conceptual Overview:

The conceptual framework proposes that the MY-MINDD retort meal intervention will improve muscle health, cognitive frailty, nutritional status, depression, and food security. Process measures include meal satisfaction, adherence, and cost-effectiveness to assess acceptability and sustainability. Potential confounding factors include socioeconomic characteristics, baseline medical conditions, psychosocial support, and lifestyle behaviors.

Study Design:

The study utilizes a 12-week, two-arm, single-blinded, cluster randomized controlled trial. Two comparable low-income housing clusters in Kuala Lumpur (PPR Seri Alam Fasa 2 and PPA Loke Yew) serve as the randomization units. Cluster assignment is determined through simple random allocation. The intervention cluster receives MY-MINDD-based retort meals through the MoW program for 12 weeks, while the control cluster undergoes the same assessment schedule and receives the meals after study completion, known as the wait-list control. Cluster randomization is used to reduce contamination and reflect real-world MoW implementation.

Study Location:

The study is conducted in PPR Seri Alam Fasa 2 and PA Loke Yew, Kuala Lumpur. These sites have substantial populations of older adults in the B40 socioeconomic group, established community networks, and feasible distribution channels for MoW services.

Study Population and Sampling:

The target population includes Malaysian older adults aged 60-84 years residing in selected clusters and classified under the B40 income category. These individuals face higher risks of food insecurity and malnutrition. Recruitment is conducted through purposive selection of clusters and snowball sampling within each cluster. The total sample comprises 70 participants (35 per cluster).

Sample Size Justification:

A total of 70 participants is considered sufficient based on comparability with previous randomized nutrition intervention trials with similar sample sizes and measurable outcomes. The 12-week intervention is expected to produce detectable changes in nutritional and functional outcomes relevant to older adults.

Intervention Description:

The MY-MINDD diet incorporates Malaysian food culture and locally available nutrient-dense ingredients. Menu development is conducted by qualified dietitians and nutritionists to ensure compliance with dietary principles and nutrient adequacy for older adults.

Participants in the intervention group receive:

Two MY-MINDD-based retort main meals per day, five days per week (10 meals weekly) Legume-based snacks (two to three times weekly) Weekly distributions of vacuum-packed vegetables, fresh fruits, and soy milk Retort meals are produced using standardized high-temperature processing to ensure safety, extended shelf life, and nutritional preservation. Participants receive printed user guides and safety instructions on meal reheating, food handling, and emergency procedures. Weekly distribution sessions include brief feedback collection to monitor adherence, acceptability, and meal quality.

Participants in the control group receive no meals during the study period but follow identical assessment schedules. They receive MY-MINDD retort meals after completion of the study to ensure ethical fairness.

Research Instruments:

Validated and standardized instruments are used to collect data on:

Socioeconomic characteristics and medical history Diet quality (MY-MINDD scoring system) Food security (Household Food Security Survey Module (HFSSM) (USDA 6-Item version)) Depression (Geriatric depression scale -15 (GDS-15)) Anthropometry (body weight, height or arm span, waist circumference, calf circumference, body composition via Bioelectrical Impedance Analysis (BIA)) Sarcopenia (Asian Working Group for Sarcopenia (AWGS) 2019 criteria) Cognitive frailty (Montreal Cognitive Assessment (MoCA) and Fried Frailty Phenotype (FFP)) Blood biomarkers (Brain-Derived Neurotrophic Factor (BDNF)) Sun exposure indices (Sun Exposure and Protection Index (SEPI), Sun Exposure Index (SEI)) Cost-effectiveness measures (health-related costs and quality-of-life metrics)

Data Analysis:

Quantitative analyses include paired t-tests, ANOVA, chi-square tests, and logistic regression. Mixed-effects models will evaluate repeated measures across clusters and time points. Continuous variables will be analyzed using linear mixed-effects models, while categorical outcomes will be analyzed using generalized linear mixed models with random intercepts for cluster and participant.

Future Directions and Sustainability:

The intervention has potential for scalability in community-based nutrition programs for older adults. Long-term sustainability may be strengthened through collaboration with local councils, welfare departments, and food industry partners. Cost-effectiveness findings may inform policymaking, budgeting, and nationwide MoW implementation. Embedding the program within existing community support systems may enhance continuity and maximize public health impact.

Enrollment: 70 estimated patients

Sex: All

Ages: 60 to 84 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Malaysian older adults aged 60 to 84 years.
• Classified under the B40 income group.
• Preferably living independently, without receiving daily meals from family members; cohabitation with other older adults is acceptable if meal support is not provided.
• Experiencing food insecurity as assessed by screening questionnaires.
• Able to provide informed consent.
• Participate in the study for the full duration.
• Able to stand without support.
• For older adults living with a spouse, preferably both partners must be eligible, willing to participate, and recruited for the study.

Exclusion criteria

• Individuals with diagnosed terminal illnesses (e.g., cancer, end-stage liver failure, end-stage lung disease, and severe form of heart diseases) and having medical conditions requiring specialized dietary restrictions (e.g., chronic/end-stage renal disease, severe dysphagia).
• Those with cognitive impairments or disabilities that prevent them from understanding the study procedures or providing consent.
• Participants or their spouse enrolled in other nutrition-related intervention programs during the study period.
• Those unwilling or unable to adhere to the intervention protocol.
• Bedridden
• Handicapped or amputated
• Wearing pacemaker
• Vegetarian, food allergies or food intolerance

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

PPA Loke Yew (Control Group)

No Intervention group

Description:

Participants in the control group will continue with their usual daily dietary intake and routine living activities without receiving any intervention throughout the 3-month study period. However, they will be assured that they will receive the reMIND meals upon study completion, both for ethical reasons and as an appreciation for their participation and cooperation, known as wait-list control design. This post-study provision also aims to help alleviate food insecurity among participants. This arrangement ensures ethical equity between groups while maintaining the validity of the control condition. It may also help enhance participants' dietary awareness and motivation toward healthier eating habits in the future. Data collection for this group will occur three times, at baseline (week 1), mid-intervention (week 6), and post-intervention (week 12), mirroring the schedule of the intervention group to maintain consistency. To minimise bias, basic nutrition education will be provided.

PPA Seri Alam Fasa 2 (Intervention Group)

Experimental group

Description:

Participants in the intervention group will receive home-delivered reMIND meals for a duration of 3 months, in addition to their usual dietary intake and daily activities. The retort meals will be nutritionally balanced and portion-controlled, designed in accordance with the Recommended Nutrient Intakes (RNI) Malaysia for older adults and the MY-MINDD dietary concept. These meals are formulated to meet the nutritional requirements outlined by the MY-MINDD framework, emphasising nutrient density and cognitive health support. Each participant will receive two meals per day, delivered once weekly, and will be encouraged to consume the meals as part of their regular diet. All meal plans will be developed by qualified dietitians and nutritionists to ensure appropriate macronutrient and micronutrient composition, food safety, and palatability. At the baseline visit, participants will receive brief dietary guidance and educational materials.

Treatment:

Other: PPR Seri Alam Fasa 2 (Intervention Group)