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

4. maj 2026 opdateret af: University of Lahore

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.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

90

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: 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.
Eksperimentel: 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.
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.
Eksperimentel: 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.
This is the fortified version of the standard FMM, with added essential micronutrients to improve nutritional status.
Eksperimentel: 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.
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.
A structured physical activity regimen appropriate for older adults was implemented daily. The activities were designed to enhance muscle strength, mobility, and overall health.
Eksperimentel: 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.
This is the fortified version of the standard FMM, with added essential micronutrients to improve nutritional status.
A structured physical activity regimen appropriate for older adults was implemented daily. The activities were designed to enhance muscle strength, mobility, and overall health.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Nutritional Status
Tidsramme: 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.
Baseline and after 12 weeks of intervention

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. august 2025

Primær færdiggørelse (Faktiske)

1. november 2025

Studieafslutning (Faktiske)

5. november 2025

Datoer for studieregistrering

Først indsendt

14. april 2026

Først indsendt, der opfyldte QC-kriterier

4. maj 2026

Først opslået (Faktiske)

6. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. maj 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

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INGEN

IPD-planbeskrivelse

Primary reason for not sharing the IPD is to protect participants privacy.

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