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

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.

Study Overview

• Status: Completed
• Conditions: Malnutrition Elderly
• Intervention / Treatment: Dietary supplement: Protein-Enriched Food Multi-Mix (FMM); Dietary supplement: Fortified Food Multi-Mix (FMM); Other: Physical Activity

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab Province
    • Lahore, Punjab Province, Pakistan
      • Community

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group (Group 1); 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.
Experimental: Protein-Enriched Food Multi-Mix (FMM) (Group 2); 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.	Dietary supplement: 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.
Experimental: Fortified Food Multi-Mix (FMM) (Group 3); 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.	Dietary supplement: Fortified Food Multi-Mix (FMM); This is the fortified version of the standard FMM, with added essential micronutrients to improve nutritional status.
Experimental: Food Multi-Mix (FMM)+ Physical Activity (Group 4); 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.	Dietary supplement: 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.; Other: Physical 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.
Experimental: Fortified Food Multi-Mix (FMM) + Physical Activity (Group 5); 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.	Dietary supplement: Fortified Food Multi-Mix (FMM); This is the fortified version of the standard FMM, with added essential micronutrients to improve nutritional status.; Other: Physical 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and after 12 weeks of intervention

Collaborators and Investigators

• Sponsor: University of Lahore

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2025
• Primary Completion (Actual): November 1, 2025
• Study Completion (Actual): November 5, 2025

Study Registration Dates

• First Submitted: April 14, 2026
• First Submitted That Met QC Criteria: May 4, 2026
• First Posted (Actual): May 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Malnutrition; Undernutrition; Food multi-mix
• Additional Relevant MeSH Terms: Nutrition Disorders; Nutritional and Metabolic Diseases; Malnutrition; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: REC-UOL-/491/08/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Primary reason for not sharing the IPD is to protect participants privacy.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No