An interventional study of PPR Seri Alam Fasa 2 (Intervention Group) in Sarcopenia, Cognitive Frailty and Nutritional Interventions, sponsored by Universiti Putra Malaysia. Not yet recruiting at 2 sites in Malaysia. Open to participants aged 60 Years to 84 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-05.
Sponsored by Universiti Putra Malaysia · Not applicable, Interventional, and Prevention
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.
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.
1,329 studies on the registry are indexed under Sarcopenia; 420 are open to participants now.
This study's planned enrollment of 70 is above the median of 60 across 855 interventional studies indexed under Sarcopenia.
Browse Sarcopenia studies →Universiti Putra Malaysia is the lead sponsor of 145 studies on the registry; 50 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Other: PPR Seri Alam Fasa 2 (Intervention Group)
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.
Also known as: reMIND
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
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
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
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
Body weight in kilograms (kg)
Body weight will be assessed using BIA with the InBody 270 device. 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.
Time frame: 3 months
Body mass index (BMI) in kilograms per square meter (kg/m²)
BMI, which will be obtained by dividing body weight in kilograms by the square of height in meters (kg/m²). Among older adults, an optimal BMI is expected to fall between 24 and 27 kg/m². Readings below 24 kg/m² will indicate underweight status, while values exceeding 27 kg/m² will reflect overweight conditions.
Time frame: 3 months
Body fat percentage in percentage (%)
Body fat percentage will be measured using BIA. Male participants presenting with 25% or more body fat will be identified as obese, while those below this level will be considered non-obese. For females, obesity will be defined at 35% or higher body fat, with measurements under this threshold reflecting a non-obese status.
Time frame: 3 months
Waist circumference in centimetres (cm)
Waist circumference of the participants will be measured using a metal measuring tape. Male participants with a waist circumference of 90 cm or above will be categorized as having abdominal obesity, while those with measurements below 90 cm will be considered non-abdominally obese. For female participants, abdominal obesity will be defined as a waist circumference of 80 cm or greater, with values under 80 cm classified as non-abdominally obese.
Time frame: 3 months
Calf circumference in centimetres (cm)
Calf circumference will be assessed using a metal measuring tape. The measurement will be taken at the widest part of the calf, ensuring the tape is positioned horizontally and parallel to the floor. During the assessment, participants will be seated with knees and ankles flexed at 90°, feet resting flat on the ground. To ensure precision, the tape will be placed directly on the skin without clothing interference.
Time frame: 3 months
Cognitive performance
Cognitive frailty will be evaluated based on the presence of both cognitive impairment and physical frailty. Cognitive performance will be assessed using the MoCA, which is scored from 0 to 30, with higher scores indicating better cognitive function. For classification purposes, MoCA scores will be interpreted as follows: Normal cognition: 26-30; MCI: 18-25; Moderate to severe impairment: ≤17 Participants who demonstrate mild cognitive impairment (MoCA score 18-25) in combination with pre-frailty or frailty (FFP score ≥2) will be classified as having cognitive frailty.
Time frame: 3 months
Malaysian-MIND diet (MY-MINDD) score
Baseline and follow-up 7-day diet histories will be collected, and adherence to the MY-MINDD will be evaluated using the MY-MINDD score, a tool specifically developed for Malaysian older adults. Dietary intake will be assessed based on 11 food groups: whole grains, green leafy vegetables, other vegetables, flavonoid-rich fruits, deep-sea fish (non-fried), poultry (non-fried), legumes and soy products, desserts, sweetened kuih and beverages, red meat, fried/fast foods, and butter/margarine. Each group will be scored according to intake frequency and serving sizes (0, 0.5, or 1). The total score will be obtained by summing all components, with a maximum of 11 points, which is a modified version of the original MIND diet score (15 points). An increased score will denote stronger compliance with the MY-MINDD dietary guidelines.
Time frame: 3 months
Unintentional Weight Loss in kilogram (kg)
Unintentional weight loss will be assessed by self-report. Participants will be asked whether they have experienced an unintentional weight loss of \>10 kg of their body weight within the past 12 months. Participants meeting this criterion will be classified as fulfilling the weight loss component of the FFP.
Time frame: 3 months
Exhaustion
Exhaustion will be assessed using two items from the Center for Epidemiologic Studies Depression Scale (CES-D): "I felt that everything I did was an effort," and "I could not get going." Participants reporting either symptom for ≥3 days per week during the past week will be classified as having exhaustion, thereby fulfilling the exhaustion component of the FFP.
Time frame: 3 months
Physical Performance in seconds (s)
Physical performance will be assessed using the 5t-CST. Participants will be instructed to stand up and sit down five times as quickly as possible from a standard chair without using their arms. The total time to complete five repetitions will be recorded in seconds. Slowness will be defined based on established cut-off values for the 5t-CST. Participants with performance times exceeding the specified threshold will be classified as fulfilling the slowness component of the FFP.
Time frame: 3 months
Physical Activity Score
Physical activity level will be assessed using a validated PASE questionnaire. The PASE assesses the frequency and duration of leisure-time, household, and occupational physical activities performed over the previous 7 days. Weekly energy expenditure will be calculated and expressed in kilocalories per week (kcal/week). Low physical activity will be defined according to sex-specific cut-off values consistent with the FFP. Participants with weekly energy expenditure below the specified thresholds will be classified as fulfilling the low physical activity component of the Fried Frailty Phenotype.
Time frame: 3 months
Frailty
Frailty will be assessed using the FFP, a validated multidimensional construct comprising five components: unintentional weight loss, exhaustion, weakness, slowness, and low physical activity. Each component will be assessed according to standardized criteria. Participants will be classified based on the total number of criteria met: robust (0 criteria), pre-frail (1-2 criteria), and frail (≥3 criteria). Frailty status will be used as a categorical outcome measure in the present study.
Time frame: 3 months
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
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
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
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
Plan to share: No
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Start is estimated for Jun 2026; primary completion for Nov 2026, 5 months later.
Of 492 non-industry interventional studies with no phase under Sarcopenia, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 34. This study's planned 5 months is below that.
Counting every sponsor, half of 503 studies reached it within 18 months; a quarter within 8 and three quarters within 34.
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