Protein-Enriched Food Multi-Mix Impact on Nutritional Status of Community-Residing Older Adults
4 mai 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
90
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Punjab Province
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Lahore, Punjab Province, Pakistan
- Community
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La 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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Aucune 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.
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Expérimental: 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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Expérimental: 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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Expérimental: 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.
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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.
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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Expérimental: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Nutritional Status
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 août 2025
Achèvement primaire (Réel)
1 novembre 2025
Achèvement de l'étude (Réel)
5 novembre 2025
Dates d'inscription aux études
Première soumission
14 avril 2026
Première soumission répondant aux critères de contrôle qualité
4 mai 2026
Première publication (Réel)
6 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
6 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
4 mai 2026
Dernière vérification
1 avril 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- REC-UOL-/491/08/24
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
Primary reason for not sharing the IPD is to protect participants privacy.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .