Skip to main content
OpenTrials
Completed

NCT Number: NCT04496856

Effects of Whey and Collagen on FFM, Muscle Strength and Wound Healing in Elderly Surgical Patients

The purpose of the study is to compare the effect of whey protein and collagen on fat free mass, muscle strength, functional ability, wound healing and life quality in elderly patients undergoing elective knee- or hip surgery (defined as elective knee- or hip arthroplasty). The patients are admitted at the department of Orthopaedic Surgery at Herlev Gentofte Hospital.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hip Arthritis Atrophy Knee Arthritis Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Herlev/Gentofte Hospital

Gentofte Municipality, Hellerup, 2900, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 65+ years
  • Scheduled elective knee- or hip surgery
  • Must be able to understand and speak danish
  • Must be able to chew and swallow food with a regular consistency
  • Must be able to consume the assigned protein supplementation
  • Must be able to consent participation

Exclusion criteria

  • Vegan
  • Demensia
  • Critical complications to the surgery which prevents the patient from participating in the rehabilitation program
  • Plasma-creatinin above 250 micromol/L
  • Palliative patients
  • Known intolerance of whey protein and/or collagen
  • Patients with a pacemaker

Treatment and study plan

Whey protein and Collagen supplementation

Dietary Supplement

Participants of each arm will consume 30 g daily of the assigned protein supplementation for 30 days. The protein supplementation will be given as protein powder which the participants will have to dissolve in cold drinks. During the intervention fat free mass, muscle strength, functional ability, wound healing and life quality of the participants will be monitored.

Primary outcomes

  1. The difference in fat free mass

    Time frame: Weekly for 30 days

    The outcome will be monitored through BIA and the development of fat free mass in the operated leg will be compared to the development of fat free mass in the non-operated leg.

Secondary outcomes

  1. Wound healing

    Time frame: Weekly for 30 days

    The amount of days until the wound is healed (defined as: the epithelium is covered without crust). This will be monitored trough pictures and assessed on a scale from 1-5 by a masked doctor.

  2. Redness and infection

    Time frame: Weekly for 30 days

    The redness and infection around the wound assessed on a scale from 1-5 by a masked doctor through pictures.

  3. Handgrip strength

    Time frame: Weekly for 30 days

    Handgrip strength measured by a handdynanometer (SAEHAN) in kg and percentage

  4. Extension strength of quadriceps femoris

    Time frame: Weekly for 30 days

    Measured in amounts of repetitions of 0.5 or 1.0 kg.

  5. Life quality

    Time frame: Weekly for 30 days

    Measured trough EuroQol-5D-5L

  6. Difference in functional ability (NMS)

    Time frame: Weekly 30 days

    Assessed by New mobility score

  7. Difference in Chair stand test

    Time frame: Weekly for 30 days

    Measured by amount of repetitions

Other outcomes

  1. Palatability of the protein supplementation

    Time frame: 30 days

    Assessed on a scale from 1-5

  2. Consistency of the protein supplementation

    Time frame: 30 days

    Assessed on a scale from 1-5

  3. Compliance of the protein supplementation intake

    Time frame: Weekly for 30 days

    Assessed trough a weekly form, which the participants will fill in

  4. Rapported side effects

    Time frame: 30 days

    Participants will be informed to rapport if they experience any side effects throughout the intervention

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Herlev and Gentofte Hospital

Registry information

Official study title

The Effects of Whey Protein and Collagen on Fat Free Mass, Muscle Strength and Wound Healing in Elderly Patients Undergoing Elective Knee- or Hip Surgery

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 3, 2020
Registry last updated
Sep 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.