Malnutrition ElderlyNCT07569809
Protein-Enriched Food Multi-Mix Impact on Nutritional Status of Community-Residing Older Adults
A study testing Protein-Enriched Food Multi-Mix (FMM), Fortified Food Multi-Mix (FMM) and Physical Activity in people with Malnutrition Elderly, run by University of Lahore at 1 site in Pakistan.
Trial summary
Malnutrition is a major health concern among older adults in Pakistan due to cultural, economic, and health barriers that limit proper nutrition. This study aims to develop a culturally appropriate, protein-enriched food multi-mix (FMM) using locally available cereals, legumes, and soybean meal to improve the… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Malnutrition Elderly
- What is being tested?
- Protein-Enriched Food Multi-Mix (FMM), Fortified Food Multi-Mix (FMM) and Physical Activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2025to 5 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- People aged 60 years and above
- Community-residing older adults
- Older adults without severe chronic diseases (e.g., end-stage renal disease, liver cirrhosis, uncontrolled diabetes, and cancer)
- Older adults following a normal diet with no dietary restriction
- Able to eat themselves
- Willing to participate in the study
- Willing to follow the study protocol, including dietary intervention
Who cannot join
- Critically ill patients admitted to the hospital
- Older adults having medical conditions that require a restriction of protein-enriched foods
- Persons with a mental illness and disability
- People who are allergic to protein
- Older adults having malabsorption syndrome and swallowing problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Protein Enriched Food Multi-Mix' Nutritional Status in Community-Residing Older Adults
Malnutrition is a major health concern among older adults in Pakistan due to cultural, economic, and health barriers that limit proper nutrition. This study aims to develop a culturally appropriate, protein-enriched food multi-mix (FMM) using locally available cereals, legumes, and soybean meal to improve the nutritional status of older adults. The study includes both a cross-sectional survey to assess malnutrition prevalence and a randomized controlled trial to evaluate the impact of the FMM intervention.
Read the detailed description
Malnutrition, particularly under nutrition poses a significant threat to the health and quality of life of older adults in Pakistan. Age-related changes in body composition, including a decrease in total body protein, lead to complications such as poor wound healing, reduced skin elasticity, and lower resistance to infection. Many older adults in Pakistan are unable to meet their daily protein requirements due to socioeconomic and dietary constraints. This project aims to develop a protein-enriched food multi-mix (FMM) tailored to the cultural preferences and nutritional needs of older adults in Pakistan. The concept of FMM is a novel and scientific approach to food diversification, combining traditional food knowledge with modern food technology. A randomized control trial was conducted to investigate the efficacy of the proposed protein-enriched recipe. The duration of the intervention study was 3 months, and one serving of the product was given to the study participants.
- Conditions
- Malnutrition Elderly
- Being tested
- Protein-Enriched Food Multi-Mix (FMM), Fortified Food Multi-Mix (FMM), Physical Activity
- Keywords
- Malnutrition, Undernutrition, Food multi-mix
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein-Enriched Food Multi-Mix (FMM)Dietary supplement
The FMM was developed using locally sourced cereals and legumes and was enhanced with soybean meal. It was tailored to the taste preferences and dietary needs of older adults.
Fortified Food Multi-Mix (FMM)Dietary supplement
This is the fortified version of the standard FMM, with added essential micronutrients to improve nutritional status.
Physical ActivityOther
A structured physical activity regimen appropriate for older adults was implemented daily. The activities were designed to enhance muscle strength, mobility, and overall health.
| Study group | Role | What they receive |
|---|---|---|
| Control Group (Group 1) | No intervention | Participants in this group continued their usual diet without any additional intervention. Their nutritional status was monitored throughout the study as a baseline reference for comparison. |
| Protein-Enriched Food Multi-Mix (FMM) (Group 2) | Experimental | Participants received a protein-enriched food multi-mix (FMM) developed from locally available cereals, legumes, and soybean meal. The FMM is culturally tailored and designed to enhance the dietary protein intake of older adults. Receives: Dietary Supplement: Protein-Enriched Food Multi-Mix (FMM) |
| Fortified Food Multi-Mix (FMM) (Group 3) | Experimental | Participants received a version of the FMM that is fortified with additional micronutrients (e.g., vitamins and minerals) to address both malnutrition and common micronutrient deficiencies among older adults. Receives: Dietary Supplement: Fortified Food Multi-Mix (FMM) |
| Food Multi-Mix (FMM)+ Physical Activity (Group 4) | Experimental | The standard protein-enriched FMM along with a structured daily physical activity regimen tailored for older adults. This group is designed to assess the synergistic effect of nutrition and physical activity on overall health and function. Receives: Dietary Supplement: Protein-Enriched Food Multi-Mix (FMM); Other: Physical Activity |
| Fortified Food Multi-Mix (FMM) + Physical Activity (Group 5) | Experimental | The fortified version of the FMM was given to the participants combined with a structured daily physical activity plan. This group is intended to evaluate the combined effect of enhanced nutrition and exercise on nutritional status and physical performance. Receives: Dietary Supplement: Fortified Food Multi-Mix (FMM); Other: Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Nutritional Status
Nutritional status was assessed by using the Mini-Nutritional Assessment-Short Form (MNA-SF), a validated screening tool with scores ranging from 0 to 14, where higher scores indicate better nutritional status and lower scores indicate risk of malnutrition or malnutrition. This form consists of six main items and has a scoring of a total of 14 points classified as normal (12-14), at risk of malnutrition (8-11), and malnourished (0-7). The difference in MNA-SF scores before and after the intervention was measured to evaluate the effectiveness of the FMM and physical activity.
Measured: Baseline and after 12 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start1 Aug 2025
- Primary completion1 Nov 2025
- Study completion5 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malnutrition ElderlyStudies of the same condition, open and under way.
- More trials run by University of LahoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study involved five parallel groups: 1) a control group consuming their normal diet 2) one receiving the protein-enriched food multi-mix (FMM), 3) one receiving Fortified FMM, 4) one receiving FMM with daily physical activity, 5) one receiving fortified FMM with daily Physical activity
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07569809
- Sponsor's protocol ID
- REC-UOL-/491/08/24
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Primary reason for not sharing the IPD is to protect participants privacy.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protein Enriched Food Multi-Mix' Nutritional Status in Community-Residing Older Adults
- ClinicalTrials.gov ID
- NCT07569809
- Acronym / sponsor ID
- REC-UOL-/491/08/24
- Conditions
- Malnutrition Elderly
- Keywords
- Malnutrition, Undernutrition, Food multi-mix
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 5 Nov 2025 (actual)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Malnutrition is a major health concern among older adults in Pakistan due to cultural, economic, and health barriers that limit proper nutrition. This study aims to develop a culturally appropriate, protein-enriched food multi-mix (FMM) using locally available cereals, legumes, and soybean meal to improve the nutritional status of older adults. The study includes both a cross-sectional survey to assess malnutrition prevalence and a randomized controlled trial to evaluate the impact of the FMM intervention.
Detailed description
Malnutrition, particularly under nutrition poses a significant threat to the health and quality of life of older adults in Pakistan. Age-related changes in body composition, including a decrease in total body protein, lead to complications such as poor wound healing, reduced skin elasticity, and lower resistance to infection. Many older adults in Pakistan are unable to meet their daily protein requirements due to socioeconomic and dietary constraints. This project aims to develop a protein-enriched food multi-mix (FMM) tailored to the cultural preferences and nutritional needs of older adults in Pakistan. The concept of FMM is a novel and scientific approach to food diversification, combining traditional food knowledge with modern food technology. A randomized control trial was conducted to investigate the efficacy of the proposed protein-enriched recipe. The duration of the intervention study was 3 months, and one serving of the product was given to the study participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- The study involved five parallel groups: 1) a control group consuming their normal diet 2) one receiving the protein-enriched food multi-mix (FMM), 3) one receiving Fortified FMM, 4) one receiving FMM with daily physical activity, 5) one receiving fortified FMM with daily Physical activity
| Arm | Type | Receives |
|---|---|---|
| Control Group (Group 1) | No intervention | –Participants in this group continued their usual diet without any additional intervention. Their nutritional status was monitored throughout the study as a baseline reference for comparison. |
| Protein-Enriched Food Multi-Mix (FMM) (Group 2) | Experimental | Dietary Supplement: Protein-Enriched Food Multi-Mix (FMM)Participants received a protein-enriched food multi-mix (FMM) developed from locally available cereals, legumes, and soybean meal. The FMM is culturally tailored and designed to enhance the dietary protein intake of older adults. |
| Fortified Food Multi-Mix (FMM) (Group 3) | Experimental | Dietary Supplement: Fortified Food Multi-Mix (FMM)Participants received a version of the FMM that is fortified with additional micronutrients (e.g., vitamins and minerals) to address both malnutrition and common micronutrient deficiencies among older adults. |
| Food Multi-Mix (FMM)+ Physical Activity (Group 4) | Experimental | Dietary Supplement: Protein-Enriched Food Multi-Mix (FMM), Other: Physical ActivityThe standard protein-enriched FMM along with a structured daily physical activity regimen tailored for older adults. This group is designed to assess the synergistic effect of nutrition and physical activity on overall health and function. |
| Fortified Food Multi-Mix (FMM) + Physical Activity (Group 5) | Experimental | Dietary Supplement: Fortified Food Multi-Mix (FMM), Other: Physical ActivityThe fortified version of the FMM was given to the participants combined with a structured daily physical activity plan. This group is intended to evaluate the combined effect of enhanced nutrition and exercise on nutritional status and physical performance. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- People aged 60 years and above
- Community-residing older adults
- Older adults without severe chronic diseases (e.g., end-stage renal disease, liver cirrhosis, uncontrolled diabetes, and cancer)
- Older adults following a normal diet with no dietary restriction
- Able to eat themselves
Key exclusion criteria (5 listed)
- Critically ill patients admitted to the hospital
- Older adults having medical conditions that require a restriction of protein-enriched foods
- Persons with a mental illness and disability
- People who are allergic to protein
- Older adults having malabsorption syndrome and swallowing problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protein-Enriched Food Multi-Mix (FMM)The FMM was developed using locally sourced cereals and legumes and was enhanced with soybean meal. It was tailored to the taste preferences and dietary needs of older adults. | Dietary supplement | Food Multi-Mix (FMM)+ Physical Activity (Group 4), Protein-Enriched Food Multi-Mix (FMM) (Group 2) |
| Fortified Food Multi-Mix (FMM)This is the fortified version of the standard FMM, with added essential micronutrients to improve nutritional status. | Dietary supplement | Fortified Food Multi-Mix (FMM) (Group 3), Fortified Food Multi-Mix (FMM) + Physical Activity (Group 5) |
| Physical ActivityA structured physical activity regimen appropriate for older adults was implemented daily. The activities were designed to enhance muscle strength, mobility, and overall health. | Other | Food Multi-Mix (FMM)+ Physical Activity (Group 4), Fortified Food Multi-Mix (FMM) + Physical Activity (Group 5) |
Primary outcome
Change in Nutritional Status
Time frame: Baseline and after 12 weeks of intervention
Nutritional status was assessed by using the Mini-Nutritional Assessment-Short Form (MNA-SF), a validated screening tool with scores ranging from 0 to 14, where higher scores indicate better nutritional status and lower scores indicate risk of malnutrition or malnutrition. This form consists of six main items and has a scoring of a total of 14 points classified as normal (12-14), at risk of malnutrition (8-11), and malnourished (0-7). The difference in MNA-SF scores before and after the intervention was measured to evaluate the effectiveness of the FMM and physical activity.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No. Primary reason for not sharing the IPD is to protect participants privacy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein-Enriched Food Multi-Mix (FMM), Fortified Food Multi-Mix (FMM) and Physical Activity in people with Malnutrition Elderly, run by University of Lahore at 1 site in Pakistan.
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 7 inclusion and 5 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: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Nutritional Status (time frame: Baseline and after 12 weeks of intervention). 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 6 May 2026.