ProMuscle, A protein supplementation and exercise strategy to promote muscle protein anabolism in frail elderly people

Sarcopenia is the age associated loss of skeletal muscle mass and function.
Especially frail elders have a high risk for adverse health outcomes, such as
institutionalization, falls and hospitalization. Resistance-type exercise
training has been shown to represent an effective strategy to augment skeletal
muscle mass and strength and improve functional capacity in both healthy and
frail elderly people. Food intake and in particular protein intake is essential
to promote net muscle protein anabolism for both young and older subjects. It
has been described that 25-30 g of high quality protein each meal (i.e. ~10 g
essential amino acids) is sufficient to maximally stimulate skeletal muscle
protein synthesis, indicating the importance of the dose and timing of protein
supplementation.
Until now, very few studies have investigated both the effects of nutritional
supplementation and exercise on body composition in frail elderly people. In
fact, only one study has investigated the combined effect of protein
supplementation and resistance-type exercise on skeletal muscle mass, showing a
increase of 2.7% in fat free mass (FFM) after 9 months. There is no evidence
of the possible beneficial effects of timed protein supplementation in the
presence of resistance type exercise in frail elderly people. We hypothesize
that the supplementation of 15 g of protein at breakfast and lunch will
increase skeletal muscle mass frail elderly individuals. Together with the
habitual protein intake, the protein supplementation will result in
approximately 25 g per meal, which has been described as sufficient to
maximally stimulate skeletal muscle protein synthesis. Furthermore, we
hypothesize that a sufficient amount of dietary protein, supplemented as
described above, will further augment the gain in skeletal muscle mass during
resistance-type exercise training in the frail elderly.

The present study is designed to investigate whether timed protein
supplementation in the presence or absence of a resistance-type exercise
training will increase skeletal muscle mass in frail elderly.

Six month randomized control trial, with 4 arms in parallel (2x2 factorial
design). The effect of a daily protein supplementation (2x 15g provided at
breakfast and during lunch), in the presence or absence of a concomitant
resistance-type exercise training program will be investigated.

The proposed intervention is a 6 month randomized control trial, with 4 arms in
parallel (2x2 factorial design). In this study, the effect of a daily protein
supplementation (2x 15g provided at breakfast and during lunch), in the
presence or absence of a concomitant resistance-type exercise training program,
will be assessed by measuring the gain in muscle mass in 120 frail elderly
volunteers. After screening, the subjects will be randomly assigned to one of
the four intervention groups:
1. Protein group
2. Protein + resistance-type exercise
3. Placebo group
4. Placebo + resistance-type exercise

The full study comprises a screening and a 6 month intervention period in which
skeletal muscle mass is our primary outcome parameter.

Benefits
The subjects will receive a final report of the tests that will be performed.
In this report, their own results will be presented. Moreover, the final group
results will be presented after the results have been published. Food products
will not be restricted during the intervention and the participants are able to
maintain their daily activities. All the drinks will be provided during the
trial. In the exercise groups the participant will be individually trained by
an experienced trainer. It has been well established that exercise improves
physical performance in daily live. After 6 months, we think that the skeletal
muscle mass is increased and physical performance is improved. The training and
testing will be carried out in groups which also has a social aspect. After
full completion of the study, the participants will receive ¤250. The subjects
can quit the study at any time for any reason if they wish to do so.

Risks
The risks involved in participating in this experiment are minimal. A
venapunction is comparable to a normal blood collection and the only risk is
that of a small local hematoma. In total 72 ml blood will be collected
throughout the entire intervention. (48 ml to obtain plasma (creatinine,
glucose and insulin) and 24 ml to collect peripheral blood (PBMC). The incision
made for obtaining the muscle biopsy will be done by an experienced physician
and will heal completely. The test beverages are made from normal nutritional
ingredients and for this reason do not bring any health risks. The exercise
training and 1RM measurements might result in feelings of muscle soreness.
Therefore, an experienced investigator will supervise all training sessions.