To compare the effects of three different protein-enhancement strategies (whey protein (WP), mixed plant-based protein (BRFP), and use of protein-rich food products (PFP) on exercise-induced muscle damage in older adults compared to isocaloric…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
inspanningsgerelateerde spierschade, sarcopenie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Circulating creatine kinase concentration is the primary outcome.
Secondary outcome
Secondary study parameters are circulating lactate dehydrogenase
concentrations, muscle soreness, and muscle function.
Background summary
Exercise is an important strategy for the primary and secondary prevention of
chronic disease development and can improve general health, but an acute bout
of exercise also induces muscle damage. A sufficient and high-quality protein
intake is of utmost importance for muscle repair and healthy aging.
Nevertheless, more than half of Dutch elderly does not reach daily protein
intake recommendations, which underscores the need for protein-enhancement
strategies. Traditional strategies focus on animal-based protein due to its
high quality, but a high-quality mix of plant-based proteins or use of
protein-rich food products may yield similar benefits, while decreasing the
ecological footprint and improve sustainability of results.
Study objective
To compare the effects of three different protein-enhancement strategies (whey
protein (WP), mixed plant-based protein (BRFP), and use of protein-rich food
products (PFP) on exercise-induced muscle damage in older adults compared to
isocaloric carbohydrate control.
Study design
This explorative study is a partially-blind randomized controlled trial.
Participants are instructed to consume either protein supplements (WP or BRFP),
protein-rich food products (PFP) or isocaloric carbohydrate control for 4
subsequent weeks. After two weeks, participants will optionally perform a
single bout of walking exercise (30-50km), and after four weeks participants
will perform a bout of walking exercise on 4 consecutive days (Nijmegen Four
Days Marches). Pre- and post-exercise measurements are performed to investigate
the effect on EIMD and muscle soreness.
Intervention
Participants will be randomly assigned to a protein-enhancement group or
control group. Participants are instructed to consume 40g of supplement (30g of
protein)/control powder per day for five weeks, which can be dissolved in
water. The food product-group will be coached on the use of protein-rich food
products via a mobile application and receive feedback on their protein intake
during the study period.
Study burden and risks
The risks involved in participating in this study are minimal. The protein
supplements provided are generally available existing products with no adverse
effects. Protein and control supplements will be produced according to the
HACCP/ISO22000 regulations in certified facilities and using approved and
commercially available ingredients. The burden of this study is solely
attributed to site visits (9 visits) and physical examinations. Nevertheless,
site visits take primarily place during an exercise and training event, which
limits the burden. Furthermore, most study procedures do not involve any risks
for the participants. Measurements with a limited burden are blood sampling,
since it is associated with a 5% risk of developing haemorrhage, which will
fully disappear within 2 weeks and is not associated with any functional
limitations. Based on previous studies, participants in protein-enhancement
groups may benefit from improved physical performance and reduced muscle
soreness. All participants will receive a personal summary of the obtained
study results after completion of the study.
Reinier Postlaan 4
Nijmegen 6525GC
NL
Reinier Postlaan 4
Nijmegen 6525GC
NL
Listed location countries
Age
Inclusion criteria
- 60 years or older
- Registered for the Nijmegen Four Days Marches (i.e., able to walk 30-50 km on
consequtive days)
- A habitual protein intake <1.2 g/kg/d (based on the PRO55+ screening tool)
- Able to understand and perform the study procedures
- Able to use a smartphone
Exclusion criteria
- Allergic or sensitive for milk proteins, or lactose or gluten intolerant
- Diagnosed type I or type II diabetes mellitus
- Diagnosed intestinal diseases influencing the uptake of protein (i.e., active
inflammatory bowel disease, Crohn*s disease)
- Consumption of other freely available protein supplements during the study
period.
- If the subject intends to perform additional exercise bouts that cause muscle
damage in the 4 days before the single- and multiple exercise bouts.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | ClinicalTrials.gov: in afwachting van identificatienummer |
| CCMO | NL86007.091.24 |