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

2026年5月4日 更新者: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.

研究概览

详细说明

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.

研究类型

介入性

注册 (实际的)

90

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Punjab Province
      • Lahore、Punjab Province、巴基斯坦
        • Community

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
无干预: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.
实验性的: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.
实验性的: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.
实验性的: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.
实验性的: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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in Nutritional Status
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年8月1日

初级完成 (实际的)

2025年11月1日

研究完成 (实际的)

2025年11月5日

研究注册日期

首次提交

2026年4月14日

首先提交符合 QC 标准的

2026年5月4日

首次发布 (实际的)

2026年5月6日

研究记录更新

最后更新发布 (实际的)

2026年5月6日

上次提交的符合 QC 标准的更新

2026年5月4日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

IPD 计划说明

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

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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