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Chronic Kidney Disease on HemodialysisRASANCT07283926

Restorative and Supportive Meals at HomeCare

A study testing Medical Nutrition Therapy + Meal Delivery in people with Chronic Kidney Disease on Hemodialysis and Meals, run by Universiti Putra Malaysia at 4 sites in Malaysia.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

The pilot intervention study is designed to evaluate the feasibility of implementing a tailored medical nutrition therapy (MNT) meal-delivery for 25 elderly, low-income food insecure patients with end-stage kidney disease undergoing maintenance hemodialysis at dialysis centers. Read more about this study

Who is it for?
Ages 60 years and older
What is being tested?
Medical Nutrition Therapy + Meal Delivery
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
4 sitesMalaysia
Study dates
3 Nov 2025to Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Elderly patients with chronic kidney disease on hemodialysis aged 60 and above (receiving hemodialysis treatment ≥3 days/week, dialysis vintage ≥3 months), and received at least one nutrition consultation by dietitian;
  • From the low-income households based on the Malaysia's Department of Statistics criteria and food insecure;
  • With co-morbidities of hypertension and cardiovascular disease;
  • Consent to participate for 2 months period

Who cannot join

  • Patients with chronic kidney disease on hemodialysis aged 59 and below, patients undergoing peritoneal dialysis/alternate hemodialysis and peritoneal dialysis/ dialysis vintage <3 months), and have not received at least one nutrition consultation by dietitian;
  • From non low-income households based on the Malaysia's Department of Statistics criteria and food insecure
  • With co-morbidities aside from those mentioned above (i.e. diabetes, cancer, gastrointestinal disorders, liver disease or any chronic diseases requiring specialised medical nutrition therapy)
  • Patients diagnosed with food allergies or intolerance

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Malaysia4 sites
  • NKF Rotary Damansara (Selayang)

    Batu Caves, Selangor, 68100

  • NKF Charis

    Cheras, Wilayah Persekutuan Kuala Lumpu, 56000

  • NKF Good Health (Kampung Pandan)

    Kuala Lumpur, Kuala Lumpur, 55100

  • NKF Calvary

    Kuala Lumpur, Kuala Lumpur, 56000

Other trials in Malaysia

About this study

Official title: Tailored Medical Nutrition Therapy Meal Delivery for the Vulnerable Food Insecure Elderly Patients With End Stage Kidney Disease on Haemodialysis: A Feasibility Pilot Study

The pilot intervention study is designed to evaluate the feasibility of implementing a tailored medical nutrition therapy (MNT) meal-delivery for 25 elderly, low-income food insecure patients with end-stage kidney disease undergoing maintenance hemodialysis at dialysis centers. Following comprehensive baseline assessments, participants will first maintain their usual dietary patterns for a 4-week control period to establish baseline nutritional and clinical parameters. This will be followed by a 4-week intervention period during which participants will receive individually tailored MNT meals designed to meet their renal-specific nutritional requirements, including energy, protein, potassium, phosphate and sodium intake. Weekly monitoring during dialysis sessions will include assessment of adherence, dietary intake, and clinical tolerance, providing detailed insights into the feasibility, safety, and potential clinical impact of the tailored nutrition intervention in this vulnerable population.

Read the detailed description

Background Malaysia is expecting population ageing with a projection of 15% of Malaysia's population will be over 65 years by 2030. Older adults often face challenges related to food insecurity and chronic disease management, which affect their overall well-being. In 2018, 10.4% of older adults were classified as food insecure, and this number is projected to escalate with the growing older adult population. On the other hand, those suffering from chronic kidney disease (CKD) face one of the most difficult diets among clinical patients. With economic constraints, the elderly's abilities to acquire the right food could be limited, predisposing them to increased morbidity and mortality. While much work is needed to ascertain the complex interplay between food insecurity, chronic disease management, and well-being in this population, a tailored intervention programme could help improve food security and health status, yet it is not well researched.

Problem Statement Food insecure elderly patients with end-stage renal disease (ESRD) on haemodialysis (HD) in Malaysia have low adherence on renal diet and are at the highest risk of malnutrition and food-borne illness predisposing them to increased morbidity and mortality.

Justification of Study At present, there is limited evidence on availability of a tailored medical nutrition therapy (MNT) meal delivery specific for HD patients in Malaysia. While much work is needed to ascertain the complex interplay between food insecurity, chronic disease management, and well-being, a tailored intervention programme could help improve the food security and health status of elderly population in Malaysia.

Research Question(s) Can tailored MNT meal delivery improve food safety, food insecurity and nutritional status of food insecure malnourished elderly patients with ESRD on HD?

Research objectives

General Objective:

To determine the feasibility of tailored medical nutrition therapy meal delivery intervention programme for elderly patients undergoing haemodialysis

Specific Objectives:

To examine the effectiveness of tailored MNT meal delivery on food safety, food insecurity and nutritional status of food insecure elderly patients with end stage kidney disease on haemodialysis

Research methodology To accomplish the objective, a single arm crossover study is proposed to be conducted over a one-year period divided into two phases: Phase One (menu planning) and Phase Two (intervention) among food insecure malnourished elderly patients on haemodialysis. Data will be collected at 3-time points on food insecurity, nutritional status and meal satisfaction.

Expected outcomes

  1. Potentially improve nutritional intake among food insecure elderly patients on haemodialysis by using self-grown vegetables that follows good practices in Malaysian Good Agricultural Practices with good handling of post-harvest management;
  2. Extend the understanding of interplay between food insecurity, chronic disease management, and well-being of older adults, and;
  3. Establish link between community, university and industry on affordable, tailored therapeutic meals for vulnerable populations.
Being tested
Medical Nutrition Therapy + Meal Delivery
Keywords
medical nutrition therapy, meal delivery, hemodialysis, elderly, food security, socioeconomic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Medical Nutrition Therapy + Meal DeliveryOther

    Also called RASA (Restorative And Supportive Meals At HomeCare)

    The tailored medical nutrition therapy menu is planned to meet the requirement of elderly chronic kidney disease patients on hemodialysis following the needs assessment on their existing nutritional status. The menu planning is completed by registered dietitians, and the vegetables are planted and supplied by certified agriculturist adhering to the local farming standards. The recipes are analysed with the nutrients, cost and hygiene to ensure its practicality, accessibility, affordability and safety.

Study groups in NCT07283926
Study groupRoleWhat they receive
Single ArmExperimentalSequential single arm crossover intervention study: 1. Phase 1 (menu design and cost analysis) * Menu planning for tailored MNT diet suitable for elderly patients with chronic kidney disease on hemodialysis * Pilot testing of newly developed menu including sensory evaluation * Finalise standard recipes including nutrients, cost and hygiene analysis 2. Phase 2 (intervention) a) Participant's enrolment Interested participants will undergo screening and selection based on the inclusion criteria and exclusion criteria b) Time-point and Data collection Participants will undergo testing at each time-point of baseline (0 month), after 4 weeks (1 month), and 8 weeks (2 month): food insecurity tool, malnutrition assessment tool, body composition assessment, clinical assessment and dietary assessment c) Participants will provide satisfaction assessment (SERQUAL questionnaire) d) Participants will follow usual diet for 4 weeks (control period), followed by 4 weeks on the MNT meals
Receives: Other: Medical Nutrition Therapy + Meal Delivery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Nutritional status

    The nutritional status of hemodialysis patients is assessed based on the presence of protein-energy wasting (PEW), categorised as either "yes" or "no." PEW is diagnosed according to the diagnostic criteria established by International Society of Renal Nutrition and Metabolism (ISRNM). Four main categories will be evaluated to diagnose PEW: (1) Serum chemistry; (2) Body mass; (3) Muscle mass; and (4) Dietary intake. The subject is diagnosed with PEW if at least three out of these four listed categories are met, with at least one diagnostic test conducted within each category

    Measured: From enrollment to the end of intervention at 8 weeks

Secondary outcomes (17)
  1. Blood Profile (Hemoglobin)

    Assessed using standard laboratory methods from routine blood samples collected during dialysis sessions (Hemoglobin, g/dL) to determine number of participants with abnormal laboratory tests results.

    Measured: From enrollment to the end of intervention at 8 weeks

  2. Blood Profile (Albumn)

    Assessed using standard laboratory methods from routine blood samples collected during dialysis sessions (Albumin g/L) to determine number of participants with abnormal laboratory tests results.

    Measured: From enrollment to the end of intervention at 8 weeks

  3. Blood Profile (Sodium)

    Assessed using standard laboratory methods from routine blood samples collected during dialysis sessions (Sodium - mmol/L) to determine the number of participants with abnormal laboratory tests results

    Measured: From enrollment to the end of intervention at 8 weeks

  4. Blood Profile (Potassium)

    Assessed using standard laboratory methods from routine blood samples collected during dialysis sessions (Potassium - mmol/L) to determine the number of participants with abnormal laboratory tests results

    Measured: From enrollment to the end of intervention at 8 weeks

  5. Blood Profile (Phosphate)

    Assessed using standard laboratory methods from routine blood samples collected during dialysis sessions (Phosphate - mmol/L) to determine the number of participants with abnormal laboratory tests results

    Measured: From enrollment to the end of intervention at 8 weeks

  6. Blood Profile (Calcium)

    Assessed using standard laboratory methods from routine blood samples collected during dialysis sessions (Calcium - mmol/L) to determine the number of participants with abnormal laboratory tests results

    Measured: From enrollment to the end of intervention at 8 weeks

  7. Blood Profile (Lipid Profile)

    Assessed using standard laboratory methods from routine blood samples collected during dialysis sessions (Lipid Profile - mmol/L) to determine the number of participants with abnormal laboratory tests results

    Measured: From enrollment to the end of intervention at 8 weeks

  8. Blood Profile (Glycated hemoglobin - HbA1C)

    Assessed using standard laboratory methods from routine blood samples collected during dialysis sessions (Glycated hemoglobin - HbA1C in percentage) to determine the number of participants with abnormal laboratory tests results

    Measured: From enrollment to the end of intervention at 8 weeks

  9. Blood Profile (Total Iron Binding Capacity)

    Assessed using standard laboratory methods from routine blood samples collected during dialysis sessions (Total Iron Binding Capacity - umol/L) to determine the number of participants with abnormal laboratory tests results

    Measured: From enrollment to the end of intervention at 8 weeks

  10. Anthropometry markers (weight)

    The following measurements will be determined on weight in kg (dry weight, pre and post-hemodialysis) for the calculation of body mass index:

    • Dry weight to be obtain from medical record as determined by the nephrologist
    • Pre-Dialysis Weight: Weight to be taken before hemodialysis session
    • Post-Dialysis Weight: Weight to be taken after hemodialysis session

    Measured: From enrollment to the end of intervention at 8 weeks

  11. Anthropometry markers (height)

    The measurements will be determined on height in metre for the calculation of body mass index

    Measured: From enrollment to the end of intervention at 8 weeks

  12. Body Composition (Mid-arm circumference)

    Measurements on the following will be performed on mid-arm circumference (MAC) by identifying the midpoint of shoulder and elbow on the non-fistula arm, then wrap the arm with measuring tape to determine number of participants with abnormal body composition results

    Measured: From enrollment to the end of intervention at 8 weeks

  13. Body Composition (Triceps skinfold)

    Measurements on the following will be performed triceps skinfold by identifying the midpoint of shoulder and elbow on the non-fistula arm, then grasp a vertical skinfold and lift perpendicular, then measure using skinfold calliper to determine number of participants with abnormal body composition results

    Measured: From enrollment to the end of intervention at 8 weeks

  14. Body Composition (Body fat percentage)

    Measurements on the following will be performed using a bioimpedance equipment (in percentage) to determine number of participants with abnormal body composition results

    Measured: From enrollment to the end of intervention at 8 weeks

  15. Body Composition (Skeletal muscle)

    Measurements on the following will be performed using a bioimpedance equipment (in cm) to determine number of participants with abnormal body composition results

    Measured: From enrollment to the end of intervention at 8 weeks

  16. Food Insecurity (FIES)

    Assessed using the Food Insecurity Experience Scale (FIES) through an interview-based questionnaire to evaluate participants' experiences and access to adequate food over the past 12 months. The FIES-SM consists of eight questions with dichotomous yes or no responses. The responses are coded as 1 for "yes", 0 for "no" and N/A for "Don't know" or "Refused". The responses were then summed to yield raw scores ranging from 0 to 8. Responses with raw scores = 0 to 3, will be classified as food secure, raw scores = 4 to 6 will be considered as moderate food insecurity, and raw scores = 7 to 8 will be categorised as severe food insecurity.

    Measured: From enrollment to the end of intervention at 8 weeks

  17. Dietary Intake

    The dietary energy intake (DEI) and dietary protein intake (DPI) are estimated using a diet history interview for dialysis and non-dialysis day.

    During the intervention phase, participants will be provided with a food diary to record all meals and snacks consumed.

    Nutrient analysis is then calculated from these reports.

    Measured: From enrollment to the end of intervention at 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2025
  2. Study start3 Nov 2025
  3. Primary completionNov 2026 (estimated)
  4. Study completionNov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Model description
This study is designed as a sequential single arm crossover intervention study of phase 1 (menu design and cost analysis) and phase 2 (intervention).
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07283926
Sponsor's protocol ID
JKEUPM-2025-321
Other IDs
VOT 6300570
Acronym
RASA
Status last verified
Nov 2025
First submitted
17 Nov 2025
Last updated
16 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: The privacy and confidentiality of the participants are of concern to be shared in public domain.

Questions about this trial

What is this clinical trial studying?

A study testing Medical Nutrition Therapy + Meal Delivery in people with Chronic Kidney Disease on Hemodialysis and Meals, run by Universiti Putra Malaysia at 4 sites in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Nutritional status (time frame: From enrollment to the end of intervention at 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.

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