MedPath

Weight training in combination with protein supplementation in older overweight people

Not Applicable
Conditions
Sarcopenia
Musculoskeletal Diseases
Registration Number
ISRCTN14158719
Lead Sponsor
McMaster University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Ongoing
Sex
All
Target Recruitment
80
Inclusion Criteria

Current participant inclusion criteria as of 04/04/2024:
1. Male or female, between the ages of 60-85 years, inclusive
2. Willing and able to provide informed consent
3. Be in general good health meaning that the participant doesn’t have any conditions that could pose a risk when performing the measurements (determined by a medical questionnaire and according to the results of several physical performance tests)
4. Non-smoking
5. Have a body mass index (BMI) between 25-40 kg/m² (inclusive)
6. Be able to carry out normal daily living activities and not engage in an exercise training program or diet
7. Not currently taking any protein or weight loss supplements or medications known to affect protein metabolism (i.e., glucocorticoids)

Previous participant inclusion criteria:
1. Male or female, between the ages of 60-80 years, inclusive
2. Willing and able to provide informed consent
3. Be in general good health meaning that the participant doesn’t have any conditions that could pose a risk when performing the measurements (determined by a medical questionnaire and according to the results of several physical performance tests)
4. Non-smoking
5. Have a body mass index (BMI) between 25-40 kg/m² (inclusive)
6. Be able to carry out normal daily living activities and not engage in an exercise training program or diet
7. Not currently taking any protein or weight loss supplements or medications known to affect protein metabolism (i.e., glucocorticoids)

Exclusion Criteria

Current participant exclusion criteria:
1. Use of tobacco or related products
2. Vegan or vegetarian diet
3. Any concurrent medical, orthopedic, or psychiatric condition that, in the opinion of the Investigator, would compromise his/her ability to comply with the study requirements
4. Use assistive walking devices (e.g., cane or walker)
5. History of cancer within the last 5 years, except basal cell carcinoma, non-squamous skin carcinoma, prostate cancer or carcinoma in situ, with no significant progression over the past 2 years
6. Significant orthopedic, cardiovascular, pulmonary, renal, liver, infectious disease, immune disorder, metabolic/endocrine disorders, or other diseases that would preclude oral protein supplement ingestion and/or assessment of safety and study objectives (except for drug-treated stage 1 or 2 hypertension)
7. Any cachexia-related condition (e.g., relating to cancer, tuberculosis, or human immunodeficiency virus infection and acquired immune deficiency syndrome) or any genetic muscle diseases or disorders
8. Current illnesses which could interfere with the study (e.g. prolonged severe diarrhea, regurgitation, difficulty swallowing)
9. Hypersensitivity or known allergy to any of the components in the test formulations
10. Excessive alcohol consumption (>21 units/week for men and >14 units/week for women)
11. History of bleeding diathesis, platelet or coagulation disorders, or antiplatelet/anticoagulation therapy (up to 81mg of baby aspirin per day taken as a prophylactic is permitted)
12. Personal or family history of a clotting disorder or deep vein thrombosis
13. Routine/daily usage of non-steroidal anti-inflammatory drugs (NSAIDs, prescription use or daily use of over-the-counter medication), use of corticosteroids, testosterone replacement therapy (ingestion, injection, or transdermal), any anabolic steroid, creatine, whey protein supplements, casein or branched-chain amino acids (BCAAs) within 45 days prior to screening
14. Type 2 diabetics

Previous participant exclusion criteria:
1. Use of tobacco or related products
2. Vegan or vegetarian diet
3. Any concurrent medical, orthopedic, or psychiatric condition that, in the opinion of the Investigator, would compromise his/her ability to comply with the study requirements
4. Use assistive walking devices (e.g., cane or walker)
5. History of cancer within the last 5 years, except basal cell carcinoma, non-squamous skin carcinoma, prostate cancer or carcinoma in situ, with no significant progression over the past 2 years
6. Significant orthopedic, cardiovascular, pulmonary, renal, liver, infectious disease, immune disorder, metabolic/endocrine disorders, or other diseases that would preclude oral protein supplement ingestion and/or assessment of safety and study objectives (except for drug-treated stage 1 or 2 hypertension)
7. Any cachexia-related condition (e.g., relating to cancer, tuberculosis, or human immunodeficiency virus infection and acquired immune deficiency syndrome) or any genetic muscle diseases or disorders
8. Current illnesses which could interfere with the study (e.g. prolonged severe diarrhea, regurgitation, difficulty swallowing)
9. Hypersensitivity or known allergy to any of the components in the test formulations
10. Excessive alcohol consumption (>21 units/week for men and >14 units/week for women)
11. History of bleeding diathesis, platelet or coagulation disorders, or antiplatelet/anticoagulation therapy (up to 81mg of baby aspirin per

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath