. 2017 Mar 8;2(1):e000156. doi: 10.1136/bmjsem-2016-000156

Table 1.

Inclusion and exclusion criteria for decision of study eligibility

Inclusion criteria	Exclusion criteria
Subject is able and willing to sign the informed consent form prior to screening evaluations. Voluntary male and female adults (age 55–75 years) BMI: 19–30 kg/m² Non-smoker or smoker with a maximum of 10 cigarettes/day Subject is in good physical and mental health as established by medical history, physical examination, ECG, vital signs, results of biochemistry and haematology. Healthy volunteers with borderline-to-normal muscle mass: Definition of cut-off levels as determined by BIA measurement during screening: women SMI >22% to ≤31%, men SMI ≤31% to ≤40, 5%. Volunteers have to be non-active athletes. Amateur or professional athletes will not be included in this study. Willing to perform accompanied moderate training according to recommendations from WHO for healthy volunteers during the course of the study. Not anticipating any planned changes in lifestyle regarding activity and nutrition for the duration of the study	Women: known pregnancy, breastfeeding or intention to become pregnant during the study Volunteers with high-protein diet (>1–2 g/kg body weight) or additional intake of protein supplements/protein-containing bars or shakes Relevant history or presence of any medical disorder, potentially interfering with this study (eg, volunteers having experienced any cardiovascular events such as infarction, angina, surgical endocoronary intervention or stroke in the last 6 months or volunteers suffering from diabetes) Intake of medications that directly affect parameters of muscle or joint function or inflammation within 2 weeks prior to visit 1 or during the study For this study, clinically relevant abnormal laboratory, ECG, vital signs or physical findings at screening Known hypersensitivity to the study preparation or to single ingredients Regular intake of dietary supplements affecting muscle or joint function within 2 weeks prior to visit 1 or during the study Drug, alcohol and medication abuses Known HIV infection Known acute or chronic hepatitis B and C infection Participation in another clinical study within the last 4 weeks and concurrent participation in another clinical study Blood donation within 4 weeks prior to study start (visit 1) or during the study

Inclusion criteria

Exclusion criteria

Subject is able and willing to sign the informed consent form prior to screening evaluations.
Voluntary male and female adults (age 55–75 years)
BMI: 19–30 kg/m²
Non-smoker or smoker with a maximum of 10 cigarettes/day
Subject is in good physical and mental health as established by medical history, physical examination, ECG, vital signs, results of biochemistry and haematology.
Healthy volunteers with borderline-to-normal muscle mass: Definition of cut-off levels as determined by BIA measurement during screening: women SMI >22% to ≤31%, men SMI ≤31% to ≤40, 5%.
Volunteers have to be non-active athletes. Amateur or professional athletes will not be included in this study.
Willing to perform accompanied moderate training according to recommendations from WHO for healthy volunteers during the course of the study.
Not anticipating any planned changes in lifestyle regarding activity and nutrition for the duration of the study

Women: known pregnancy, breastfeeding or intention to become pregnant during the study
Volunteers with high-protein diet (>1–2 g/kg body weight) or additional intake of protein supplements/protein-containing bars or shakes
Relevant history or presence of any medical disorder, potentially interfering with this study (eg, volunteers having experienced any cardiovascular events such as infarction, angina, surgical endocoronary intervention or stroke in the last 6 months or volunteers suffering from diabetes)
Intake of medications that directly affect parameters of muscle or joint function or inflammation within 2 weeks prior to visit 1 or during the study
For this study, clinically relevant abnormal laboratory, ECG, vital signs or physical findings at screening
Known hypersensitivity to the study preparation or to single ingredients
Regular intake of dietary supplements affecting muscle or joint function within 2 weeks prior to visit 1 or during the study
Drug, alcohol and medication abuses
Known HIV infection
Known acute or chronic hepatitis B and C infection
Participation in another clinical study within the last 4 weeks and concurrent participation in another clinical study
Blood donation within 4 weeks prior to study start (visit 1) or during the study

BIA, Bioelectrical Impedance Analysis; BMI, Body Mass Index; SMI, Skeletal Mass Index.