A randomized, double-blind, placebo-controlled study to evaluate the benefit of LI12542F6 supplementation in conjunction with an exercise program to enhance muscle strength in healthy aging subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 3
- 主要终点
- Improvement from baseline to end of the study in
研究概览
简要总结
The purpose of this study is to assess clinical effectiveness of LI12542F6 in conjunction with an exercise program to enhance muscle strength in healthy aging subjects. A total of 92 male and female subjects of age between 55 and 70 years will be included in the study. Assessment of inclusion and exclusion criteria will be done based on clinical and laboratory investigations. The eligible subjects will be randomized as per the computer generated randomization list. The subjects will be assigned to either one of the two study groups (LI12542F6 650 mg or Placebo) at 1:1 ratio. The participants will be instructed to take two capsules daily in the morning after breakfast for 12 weeks. The outcome measures include muscle strength (1RM) using leg extension exercise, muscle fatigue using 80% 1RM to failure, 30-second sit to stand test, six minute walk test, grip strength, hs-CRP, serum testosterone and SHBG, body composition using dexa scan including lean mass, muscle quality, SF-36 quality of life questionnaire and immune function questionnaire. Besides, the study will also record the vital signs and adverse events to evaluate the herbal composition’s safety and tolerability. The safety assessment of the LI12542F6 will also include the routine laboratory investigations on blood, urine and clinical chemistry at screening and the final visit of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 55.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy, physically active-able to climb stairs, rise from a squatting position, walk along a straight line, hop on either foot, and perform typical activities of daily living without support) male and post-menopausal female subjects aged between 55 and 70 years with a Body Mass Index-BMI of between 22 and 29.9 kg per m
- •Subjects who are not sarcopenic, based on the criteria of Asian Working Group for Sarcopenia -skeletal muscle index will be greater than 7 kg per m2 in males and greater than 5.7 kg per m2 in females; Hand-grip strength will be greater than 26 kg for men and greater than 17 kg for women; Gait speed will be greater than 0.8 m per sec for both men and women.
- •Subjects who are not nutritionally deprived or malnourished.
- •Subjects with clinical lab observations within normal range or considered not clinically significant by the principal investigator.
- •Subject willing to provide written informed consent and agree to be available for regular follow up throughout the study duration.
- •Willing to participate in Strength Training Program and perform suggested exercises on three alternating days per week, for 12 weeks.
- •Willing to keep dietary records to allow macronutrient intake to be calculated during the study period.
排除标准
- •Subjects having Allergy or hypersensitivity to any of the ingredients in the investigational products.
- •Subjects with any pre-existing medical conditions which in the opinion of the investigator makes the subject unsuitable for inclusion.
- •Subjects underwent treatment for COVID 19 or tested positive during the study will be excluded.
- •Subjects with gastrointestinal diseases such as Crohns disease or gastrointestinal surgery.
- •Evidence or history of clinically significant in the judgement of the Investigator hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies, thyroid dysfunction.
- •Subjects having history of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
- •Subjects who are participating in another clinical trial or have received any investigational product within 30 days prior to visit 1-screening.
- •Any surgery or fracture in lower limb in past 6 months or any impairment or disease severely affecting gait-e.g. Parkinsons disease, peripheral polyneuropathy, intermittent claudication in advanced peripheral vascular disease, spinal stenosis, or severe osteoarthritis of the knee or hip with ineffective pain management.
- •Subjects who requires regular assistance from another person for general activities of daily living-e.g. bathing, dressing, toileting.
- •Subjects with any underlying muscle disease including active myopathy or muscular dystrophy.
- •Subjects with diabetes-FBS greater than 125mg per dL, hypertension-Systolic greater than 145 and Diastolic greater than 90 mmHg. Subjects with COPD, asthma, any respiratory or breathing related disorders.
- •Subjects consuming alcohol -greater than 5 drinks per week and smoking greater than 5 cigarettes per day.
- •Subjects using any dietary supplements that could interfere with the study outcomes, including protein, amino acids, leucine, beta-alanine, HMB or other supplements known to impact muscle.
- •Subjects under medications including anti-hypertensives, inhaled beta agonists, anti-hyperlipidemics, psychotropic etc.
- •Confirmed rheumatoid arthritis or other systemic autoimmune disease requiring immunosuppressive therapy or corticosteroids.
- •Myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention-e.g. angioplasty or stent placement, or deep vein thrombosis or pulmonary embolism within 12 weeks prior to screening.
- •Subjects with HIV positive or any other STDs.
结局指标
主要结局
Improvement from baseline to end of the study in
时间窗: Baseline, Week 4, Week 8 and Week 12
Muscle strength (1 RM) using Leg extension exercise
时间窗: Baseline, Week 4, Week 8 and Week 12
次要结局
- Improvement from baseline to end of the study in(Serum testosterone and SHBG of male subjects)