ISRCTN14158719进行中（未招募）未知
Practical strength training combined with high-quality dairy protein consumption to promote metabolic health and physical function in older overweight/obese men and women: a randomized controlled trial
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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)
排除标准
- •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
研究者
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