Protein-Enriched Food Multi-Mix Impact on Nutritional Status of Community-Residing Older Adults
4 de maio de 2026 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Real)
90
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
Punjab Province
-
Lahore, Punjab Province, Paquistão
- Community
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Sem intervenção: 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.
|
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.
|
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.
|
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.
|
|
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.
|
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Nutritional Status
Prazo: 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
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de agosto de 2025
Conclusão Primária (Real)
1 de novembro de 2025
Conclusão do estudo (Real)
5 de novembro de 2025
Datas de inscrição no estudo
Enviado pela primeira vez
14 de abril de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
4 de maio de 2026
Primeira postagem (Real)
6 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
6 de maio de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
4 de maio de 2026
Última verificação
1 de abril de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- REC-UOL-/491/08/24
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano IPD
Primary reason for not sharing the IPD is to protect participants privacy.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .