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Protein-Enriched Food Multi-Mix Impact on Nutritional Status of Community-Residing Older Adults

Protein Enriched Food Multi-Mix' Nutritional Status in Community-Residing Older Adults

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07569809
Enrollment
90
Registered
2026-05-06
Start date
2025-08-01
Completion date
2025-11-05
Last updated
2026-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malnutrition Elderly

Keywords

Malnutrition, Undernutrition, Food multi-mix

Brief 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 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.

Interventions

DIETARY_SUPPLEMENTProtein-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_SUPPLEMENTFortified Food Multi-Mix (FMM)

This is the fortified version of the standard FMM, with added essential micronutrients to improve nutritional status.

OTHERPhysical Activity

A structured physical activity regimen appropriate for older adults was implemented daily. The activities were designed to enhance muscle strength, mobility, and overall health.

Sponsors

University of Lahore
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

Open-label study; participants and investigators were aware of the intervention.

Intervention 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

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change in Nutritional StatusBaseline and after 12 weeks of interventionNutritional 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.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 7, 2026