Therefore the present study is designed to investigate the impact of additional protein intake on muscle strength and physical performance in physically active elderly. Moreover, muscle mass will be determined. Furthermore, we assess the influence…
ID
Source
Brief title
Condition
- Other condition
- Musculoskeletal and connective tissue disorders NEC
Synonym
Health condition
sarcopenie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcomes are differences in change in muscle strength and physical
performance between the intervention and control group after 12 weeks.
Moreover, muscle mass will be determined to assess differences between the
intervention and control group.
Primary outcome
Maximal voluntary contraction (leg extension strength) of 3 repeated measures
(3RM) and physical performance (determined with Short Physical Performance
Battery (SPPB)).
Secondary outcome
During the Four Days Marches we will assess differences between the
protein-supplemented group and the placebo-supplemented group for recovery of
physical performance, of muscle strength and biomarkers (muscle and joint).
Secondary study parameters are changes in:
o Muscle contractile function*
o Handgrip strength (dynamometer)
o Timed up-and-go (TUG) test
o Anthropometrics
o Body composition (DEXA)
*Performed in a subgroup of 60 subjects (30 intervention, 30 placebo)
Other parameters are:
o Physical fitness (Åstrand-Rhyming test)
o Physical activity (SQUASH) and exercise training (diary)
o Daily dietary and protein intake (24h-recalls)
o Compliance (protein supplementation)
o Blood analyses (protein, glucose and insulin (for screening diabetes),
creatinin (for screening renal insufficiency), inflammatory biomarkers, joint
markers)
o Urine analyses (protein, inflammatory biomarkers, joint markers)
o Questionnaire screening sarcopenia (SARC-F)
o Questionnaire quality of life (EQ5D)
o Questionnaire muscle and joint pain (Short-Form McGill Pain Questionnaire
(SF-MPQ) and Brief pain inventory vragenlijst (BPI-SF))
Background summary
Sarcopenia is age related loss of skeletal muscle mass, muscle strength and
muscle function. These declines can lead to a decrease in physical performance,
decreased independence and enhanced vulnerability, and subsequently increased
health care costs. Previous studies have shown beneficial effects of enhanced
protein intake in frail elderly but little is known about the effect of
enhancing protein intake in currently healthy active elderly. It has been shown
that active elderly have the same age-related declines in muscle strength as
their inactive peers, while protein recommendations are often not met in both
groups.
Study objective
Therefore the present study is designed to investigate the impact of additional
protein intake on muscle strength and physical performance in physically active
elderly. Moreover, muscle mass will be determined. Furthermore, we assess the
influence of the protein supplementation on the physical performance and muscle
and joint health during the Four Days Marches.
Study design
The proposed intervention is a 13-week double-blind randomized
placebo-controlled trial with 2 arms. The effects of daily protein
supplementation (2x 15g provided at breakfast and after exercise) on muscle
strength and physical performance will be investigated.
Intervention
The elderly will be randomly divided into the protein or placebo group. The
daily supplementation consists of a protein product (30 grams of protein) or a
placebo (consisting of carbohydrates). It will be given in the form of 2 drinks
that need to be consumed during breakfast and after exercise (or on days
without exercise during lunch).
Study burden and risks
The risks involved in participating in this experiment are minimal. Stukje
tekst over eiwitsupplement Most procedures do not involve any risks for the
subjects. The only measurements with a limited burden are blood sampling,
muscle contractile function and the DXA scan. Withdrawal of a venous blood
sample is associated with a 5% risk of developing a haemorrhage, but will fully
disappear within 2 weeks and is not associated with any (functional)
limitations. Furthermore, the electrostimulation of the quadriceps muscle might
feel unpleasant, despite the low force that is generated (30% of the maximal
voluntary contraction). Finally, the radiation dosage of a DXA-scan is 4.2 µSv,
which is not associated with any health risk.
Philips van Leijdenlaan 15
Nijmegen 6525 EX
NL
Philips van Leijdenlaan 15
Nijmegen 6525 EX
NL
Listed location countries
Age
Inclusion criteria
- 65 years or older
- Registered for the Nijmegen Four Days Marches 2017
- Protein intake less than 1.0 gram/kilogram bodyweight/day
- Able to understand and perform the study procedures
Exclusion criteria
- Type I or type II diabetes (fasted blood glucose level *7,0 mmol)
- Allergic or sensitive for milk proteins, or lactose intolerant.
- Having diagnosed COPD or treatmet with cancer
- Having diagnosed renal insufficiency
- Having diagnosed intestinal diseases influencing the uptake of protein (i.e. active inflammatory bowel disease, Crohn*s disease)
- Use of statins
- Involved in a heavy resistance type exercise program
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL60137.072.16 |
| OMON | NL-OMON23080 |