To assess the effects of intradialytic exercise and protein ingestion on amino acid loss into the dialysate and plasma total amino acid concentrations.
ID
Source
Brief title
Condition
- Appetite and general nutritional disorders
- Renal disorders (excl nephropathies)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameters are amino acid loss into the dialysate and plasma
total amino acid concentrations.
Secondary outcome
Secondary study parameters are the loss of essential amino acids into the
dialysate, plasma essential amino acid, glucose, and insulin concentrations,
interstitial glucose concentrations, and changes in blood pressure.
Background summary
Chronic hemodialysis patients suffer from poor physical functioning due to
progressive loss of skeletal muscle mass and function. Preliminary data from
our lab shows that 8 - 15 grams of amino acids are lost into the dialysate
during a hemodialysis session, causing a significant decline in plasma amino
acid concentrations. Few studies in chronic hemodialysis patients suggest that
oral protein ingestion during hemodialysis is able to prevent this decline and
associated muscle protein breakdown. However, the amount of protein required to
achieve this effect (±60 g) is not feasible for clinical practice. Nonetheless,
a feasible amount of protein combined with an additional anabolic stimulus,
such as exercise, might be able to prevent the hemodialysis-induced decline in
plasma amino acid concentrations. In healthy adults, exercise before protein
ingestion enhances the net protein balance of skeletal muscle and improves
postprandial glycemia. However, the effect of intradialytic exercise on plasma
and dialysate amino acid concentrations throughout hemodialysis is unclear. In
addition, it is not known if this effect differs between fed and fasted
patients. Knowledge about the acute metabolic response after protein ingestion
and exercise during hemodialysis is important for the development of
intradialytic anabolic strategies in chronic hemodialysis patients.
Study objective
To assess the effects of intradialytic exercise and protein ingestion on amino
acid loss into the dialysate and plasma total amino acid concentrations.
Study design
Randomized cross-over (four groups) study design.
Intervention
During four HD sessions, patients will (A) ingest a placebo drink, (B) ingest a
placebo drink and perform aerobic exercise, (C) ingest a protein supplement,
and (D) ingest a protein supplement and perform aerobic exercise. Following
initiation of the hemodialysis session, arterial plasma samples will be
obtained with 30-min intervals during a 4 h period for analysis of plasma amino
acid, glucose, and insulin concentrations. In addition, spent dialysate will be
collected and glucose monitoring will be applied continuously throughout the
hemodialysis session.
Study burden and risks
The risks involved in participating in this experiment are minimal. Blood and
spent dialysate samples will be collected from the arterial blood line and
dialysate line, respectively, without extra burden or risk for the patients.
Oral food intake during hemodialysis is routine for most patients and is well
tolerated. The protein supplements are produced according to HACCP standards
and are safe for human use. Intradialytic exercise is common practice in many
hemodialysis departments, and (serious) adverse events are rarely reported.
Universiteitsingel 50
Maastricht 6229 ER
NL
Universiteitsingel 50
Maastricht 6229 ER
NL
Listed location countries
Age
Inclusion criteria
- Aged >18 years
- Ability to provide written informed consent
- Hemodialysis treatment for >3 months
- Well-functioning arteriovenous shunt in upper or lower arm
Exclusion criteria
- Unstable cardiac status (i.e. cardiac ischemia)
- Physical limitations affecting usage of the bike
- Poor blood sugar control
- Active infection or illness
- Poorly functioning shunt
- Previous episodes of intradialytic hypotension related to food intake
- Hospitalization <3 months prior to study period
- Missed hemodialysis session <1 month prior to study period
- Allergies to milk protein
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 |
---|---|
CCMO | NL65880.068.18 |