Protein-Enriched Food Multi-Mix Impact on Nutritional Status of Community-Residing Older Adults
2026년 5월 4일 업데이트: 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.
연구 개요
상태
완전한
정황
상세 설명
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.
연구 유형
중재적
등록 (실제)
90
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Punjab Province
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Lahore, Punjab Province, 파키스탄
- Community
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: 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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실험적: 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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실험적: 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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실험적: 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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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Nutritional Status
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2025년 8월 1일
기본 완료 (실제)
2025년 11월 1일
연구 완료 (실제)
2025년 11월 5일
연구 등록 날짜
최초 제출
2026년 4월 14일
QC 기준을 충족하는 최초 제출
2026년 5월 4일
처음 게시됨 (실제)
2026년 5월 6일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 6일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 4일
마지막으로 확인됨
2026년 4월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- REC-UOL-/491/08/24
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
Primary reason for not sharing the IPD is to protect participants privacy.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .