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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-84
SponsorUniversiti Putra Malaysia

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • PPR Seri Alam Fasa 2 (Intervention Group)

    Other intervention

    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 RNI 2017 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 groups

70 Participants
are divided into 2 treatment groups
Group A: PPA Loke Yew (Control Group)No intervention 0 interventions
Group B: PPA Seri Alam Fasa 2 (Intervention Group)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Appendicular skeletal muscle mass in kilograms (kg)

Appendicular skeletal muscle mass will be estimated using BIA in kilograms (kg). Prior to the assessment, participants will be screened to confirm they are not fitted with pacemakers. To ensure standardization, they will be instructed to remove footwear, socks, and any heavy accessories, as well as to empty their pockets and bladder. During the procedure, participants will be positioned at the center of the platform, standing upright with eyes forward while firmly holding the electrodes until the measurement is completed. BIA is selected for its simplicity, non-invasive nature, and suitability for field settings. Nevertheless, as hydration status can influence the readings, bladder emptying will be emphasized as a precaution to reduce measurement variability.

Time frame
3 months
2

Appendicular skeletal muscle index (ASMI) in kilograms per square meter (kg/m²)

ASMI in kilograms per square meter (kg/m²) will be obtained by dividing an individual's appendicular skeletal muscle mass by the square of their height. Low skeletal muscle mass, a key diagnostic component of sarcopenia, was defined according to the AWGS 2025 criteria as an ASMI \<7.6 kg/m² for men aged 50-64, \<7.0 kg/m² for men aged 65 and above, and \<5.7 kg/m² for women.

Time frame
3 months
3

Muscle strength in kilograms (kg)

Muscle strength will be assessed using handgrip dynamometry and recorded in kilograms (kg). Three consecutive measurements will be obtained from the dominant hand, and the highest value will be used for analysis. Handgrip strength is a validated measure of overall muscle strength and is commonly used to assess muscular weakness. Muscle weakness will be defined according to the AWGS 2025 criteria. Low handgrip strength is defined as \<34 kg for men aged 50-64 years, \<28 kg for men aged ≥65 years, \<20 kg for women aged 50-64 years, and \<18 kg for women aged ≥65 years. Participants with handgrip strength below these sex- and age-specific thresholds will be classified as having muscle weakness. Muscle weakness identified by handgrip dynamometry will be used to operationalize the weakness component of the FFP and the muscle strength criterion within the AWGS sarcopenia framework.

Time frame
3 months
4

Height in centimetres (cm)

Participants' height will not be obtained through direct standing height but will instead be estimated from arm span length, which is regarded as a more accurate indicator for older adults due to progressive reductions in height with ageing. Arm span refers to the distance measured between the tips of the middle fingers when both arms are fully stretched out to the sides. For the measurement procedure, each participant will be asked to stand upright against a wall with their back straight and arms extended horizontally at shoulder level. Measurements will be taken three times using a standardized metal measuring tape, and the average will be used for analysis. Predictive equations developed for Malaysian older adults will then be applied: for men, Height = \[0.681 × arm span (cm)\] + 47.56; and for women, Height = \[0.851 × arm span (cm)\] + 18.78.

Time frame
3 months

Secondary outcomes

1

Incremental Cost-Effectiveness Ratio (ICER)

Direct costs for the intervention group, including food ingredients, packaging, transportation, and staff wages, will be calculated. Effectiveness will be measured using quality of life (QoL) and medical costs. Quality of life will be evaluated using CASP-19 questionnaire which consists of 19 items. Scores range from 0 to 57, with higher scores indicating better quality of life. Medical costs, including outpatient visits, hospitalization, complementary and alternative medicine (CAM) use, and post-hospitalization rehabilitation, will be self-reported by participants throughout the three-month intervention. The incremental cost-effectiveness ratio (ICER), representing the additional cost required to achieve one additional unit of health benefit, will be calculated as the difference in costs between the intervention and control groups divided by the difference in outcomes (QoL or medical costs) between the two groups.

Time frame
3 months
2

Brain-Derived Neurotrophic Factor (BDNF) in picograms per milliliter (pg/mL)

Venous blood samples will be collected from participants by trained personnel using standard aseptic procedures. The samples will be processed to obtain serum and stored appropriately before being transported to an accredited laboratory for analysis. Quantification of brain-derived neurotrophic factor (BDNF) will be conducted by laboratory experts using a commercially available enzyme-linked immunosorbent assay (ELISA) kit to ensure accuracy and reliability of the results.

Time frame
3 months
3

6-item USDA Household Food Security Survey Module (HFSSM) score

Food security will be evaluated using the validated 6-item USDA Household Food Security Survey Module (HFSSM), which includes six questions. Responses of "often" or "sometimes" to HH3 and HH4, as well as "yes" to AD1, AD2, and AD3, will be coded as affirmative. For AD1a, responses of "almost every month" or "some months but not every month" will also be considered affirmative. Each affirmative response will be awarded one point, and the total will represent the raw score. A raw score of 0-1 will indicate high or marginal food security, 2-4 will indicate low food security, and 5-6 will indicate very low food security. In this study, both English and Malay versions of the 6-item HFSSM will be administered.

Time frame
3 months
4

Depressive Symptoms

Depressive symptoms will be assessed using the 15-item Geriatric Depression Scale (GDS-15), a validated self-report screening tool for depressive symptoms in older adults. The GDS-15 evaluates mood and affect based on yes/no responses reflecting symptoms experienced over the past week. Total scores range from 0 to 15, with higher scores indicating greater depressive symptom severity. A score of ≥5 will be used to indicate the presence of depressive symptoms.

Time frame
3 months

Other outcomes

Sponsors and contacts

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Universiti Putra Malaysia

Lead sponsor

United Nations

Collaborator

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