- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07569809
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
Status
Afsluttet
Betingelser
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
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Punjab Province
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Lahore, Punjab Province, Pakistan
- Community
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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 |
|---|---|
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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.
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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.
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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.
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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.
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This is the fortified version of the standard FMM, with added essential micronutrients to improve nutritional status.
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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.
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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.
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Nutritional Status
Tidsramme: Baseline and after 12 weeks of intervention
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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.
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Baseline and after 12 weeks of intervention
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- REC-UOL-/491/08/24
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
Primary reason for not sharing the IPD is to protect participants privacy.
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