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

NCT07569809 | Completed

• 1 other identifier: REC-UOL-/491/08/24
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Malnutrition Elderly

Keywords

Malnutrition; Undernutrition; Food multi-mix

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (5)

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.

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.

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.

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.

Dietary Supplement: Fortified Food Multi-Mix (FMM); Other: Physical Activity

Interventions

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.

Food Multi-Mix (FMM)+ Physical Activity (Group 4); Protein-Enriched Food Multi-Mix (FMM) (Group 2)

Fortified Food Multi-Mix (FMM) DIETARY_SUPPLEMENT

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

Fortified Food Multi-Mix (FMM) (Group 3); Fortified Food Multi-Mix (FMM) + Physical Activity (Group 5)

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.

Food Multi-Mix (FMM)+ Physical Activity (Group 4); Fortified Food Multi-Mix (FMM) + Physical Activity (Group 5)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Lahore: lead

Study Sites (1)

Community

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Malnutrition

Interventions

Exercise

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open-label study; participants and investigators were aware of the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: May 6, 2026
• Study Start: August 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: November 5, 2025
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)