Wpływ PeptiStrong i Białka Serwatkowego na Funkcję Mięśni u Osób Starszych
Wpływ PeptiStrong i niskiej dawki białka serwatkowego w porównaniu z samą wysoką dawką białka serwatkowego na funkcję mięśni u osób starszych
Examining the effects of PeptiStrong and protein on muscle function in older adults
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Liverpool, Zjednoczone Królestwo, L3 3AF
- LJMU, Byrom Street
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Inny
- Przydział: Nielosowe
- Model interwencyjny: Przydział równoległy
- Maskowanie: Poczwórny
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: PeptiStrong + whey protein
2.4g PeptiStrong (provides 1.6g protein) + 8.4g of whey protein = 10g total protein |
Fava bean protein hydrolysate containing bioactive peptides mixed with whey protein as dry powder for drinkable protein shake |
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Aktywny komparator: Whey protein
20g whey protein |
Whey protein as dry powder for drinkable protein shake |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Hand Grip Strength via hand held dynamometer
Ramy czasowe: Baseline to Week 4
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Change from baseline to end of study in grip strength as assessed via hand held dynamometer |
Baseline to Week 4
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Chair Stand Test - Part of short performance physical battery
Ramy czasowe: Baseline to week 4
|
Change from baseline to end of study in physical function assessment via chair stands. This test measures the time taken to complete 5 sit-to-stand repetitions in seconds. A lower time (fewer seconds) = better performance. As part of the full short performance physical battery it is converted to a subscore of 0-4, where a higher score = better performance |
Baseline to week 4
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Gait Speed as part of short performance physical battery
Ramy czasowe: Baseline to week 4
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Change from baseline to end of study in physical function assessment assessed as time to walk a fixed distance in seconds and reporting in meters per second. Higher speeds indicate better performance. This is converted to a subscore of 0-4 within the full short performance physical battery |
Baseline to week 4
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6 Minute Walking Endurance Test
Ramy czasowe: Baseline to week 4
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Change from baseline to end of study in physical function and endurance assessed as the total distance walked in 6 minutes in meters. A greater distance reflects better walking endurance and functional capacity. |
Baseline to week 4
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Balance test as part of short performance physical battery
Ramy czasowe: Baseline to week 4
|
Change from baseline to end of study in balance as assessed by the ability to hold three standing positions of increasing difficulty: side-by-side, semi-tandem, and tandem stance in seconds. Higher scores indicate better balance. The overall score is converted to a a sub-score of 0-4 within the full short performance physical battery. |
Baseline to week 4
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Balance assessment via force plates
Ramy czasowe: Baseline to week 4
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Change from baseline to end of study in balance as assessed via force plates |
Baseline to week 4
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Quality of Life via the Sarcopenia Quality of Life (SarQoL®) Questionnaire
Ramy czasowe: Baseline to week 4
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Change from baseline to end of study in quality of life as measured via subjective SarQOL questionnaire. The total score ranges from 0 to 100, with higher scores reflecting a higher quality of life. |
Baseline to week 4
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Fatigue via Multidimensional Fatigue Inventory Questionnaire
Ramy czasowe: Baseline to week 4
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Change from baseline to end of study in self-reported fatigue as assessed via multidimensional fatigue inventory questionnaire. This 20-item questionnaire covers five dimensions: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation, and Reduced Activity. Each subscale score ranges from 4 to 20, with higher scores indicating greater fatigue |
Baseline to week 4
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C-reactive protein (CRP) via blood test
Ramy czasowe: Baseline to week 4
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Change from baseline to the end of study in inflammatory marker C-reactive protein (CRP) in serum as mg/L |
Baseline to week 4
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Interleukins via blood test
Ramy czasowe: Baseline to week 4
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Change from baseline to the end of study in Interleukin inflammatory markers in serum as pg/mL |
Baseline to week 4
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Body composition: Muscle mass and body fat via bioelectrical impedance analysis
Ramy czasowe: Baseline to week 4
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Change from baseline to end of study in muscle mass and body fat as measured by bioelectrical impedance analysis in kilograms and % of total body weight |
Baseline to week 4
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Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Graeme Close, Professor, Liverpool John Moore University
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- PEPVFH+60/26
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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