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Completed

NCT Number: NCT07569809

Protein-Enriched Food Multi-Mix Impact on Nutritional Status of 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.

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Key information

Conditions

Malnutrition Elderly Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Community

Lahore, Punjab Province, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 activity

Other

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Lahore

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 6, 2026
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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