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临床试验/NCT07528469
NCT07528469招募中不适用

The Effects of PeptiStrong and Low Dose Whey Protein Versus High Dose Whey Protein Alone on Muscle Function In Older Adults

Nuritas Ltd1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年4月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
80
试验地点
1
主要终点
Hand Grip Strength via hand held dynamometer

研究概览

简要总结

Examining the effects of PeptiStrong and protein on muscle function in older adults

详细描述

The aim of this study is to compare two protein drinks containing whey protein (derived from milk) in healthy adults aged 60 to 85 years. One group will consume a standard whey protein drink (20g), while the other group will consume a drink with half the total protein dose (10g) made of whey protein and PeptiStrong, a fava bean hydrolysate containing bioactive peptides.

The study will assess whether the lower protein drink containing PeptiStrong will lead to equal or greater improvements than the standard drink in physical function, such as the ability to stand up from a chair, walk at a normal pace, maintain balance, and grip strength. The study will also examine markers related to inflammation, fatigue, and quality of life.

The intended value of this research is to improve understanding of how targeted nutritional strategies may help maintain or improve muscle function in older adults. The findings may help inform future nutritional recommendations and the development of practical dietary interventions aimed at supporting healthy ageing and independence.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
60 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women aged 60 to 85 years at the time of enrolment
  • Community-dwelling (living independently or with minimal assistance)
  • Able to walk independently (with or without a walking aid) and complete simple physical function tests (such as standing up from a chair and walking short distances)
  • Willing and able to attend two study visits at the research facility (baseline and end of study)
  • Willing and able to consume a protein drink containing whey protein (derived from milk) once daily for 30 days
  • Able to understand the study information and provide written informed consent

排除标准

  • Any known food allergy or intolerance to fava bean protein or milk protein
  • Diagnosed kidney disease or any medical condition where increased protein intake is contraindicated
  • Yes to any of the answers on the "Older Adult Functional Assessment Screening Questionnaire"
  • Individuals with implanted electronic devices
  • Current or recent (within the past 3 months) participation in another clinical research study involving a nutritional or exercise intervention
  • Conditions that significantly impair mobility or balance such that safe completion of the physical function tests is not possible

研究组 & 干预措施

PeptiStrong + whey protein

Experimental

2.4g PeptiStrong (provides 1.6g protein) + 8.4g of whey protein = 10g total protein

干预措施: PeptiStrong + whey protein (Dietary Supplement)

Whey protein

Active Comparator

20g whey protein

干预措施: Whey protein (Dietary Supplement)

结局指标

主要结局

Hand Grip Strength via hand held dynamometer

时间窗: Baseline to Week 4

Change from baseline to end of study in grip strength as assessed via hand held dynamometer

次要结局

  • Chair Stand Test - Part of short performance physical battery(Baseline to week 4)
  • Gait Speed as part of short performance physical battery(Baseline to week 4)
  • 6 Minute Walking Endurance Test(Baseline to week 4)
  • Balance test as part of short performance physical battery(Baseline to week 4)
  • Balance assessment via force plates(Baseline to week 4)
  • Quality of Life via the Sarcopenia Quality of Life (SarQoL®) Questionnaire(Baseline to week 4)
  • Fatigue via Multidimensional Fatigue Inventory Questionnaire(Baseline to week 4)
  • C-reactive protein (CRP) via blood test(Baseline to week 4)
  • Interleukins via blood test(Baseline to week 4)
  • Body composition: Muscle mass and body fat via bioelectrical impedance analysis(Baseline to week 4)

研究者

发起方
Nuritas Ltd
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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