NCT06444763已完成3 期
Effect of Maolactin™ FMR Supplementation on Exercise Recovery, Inflammation, and Muscle Comfort in an Otherwise Healthy Population: A Double-blind Randomized Placebo-controlled Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- Change in Inflammatory status
研究概览
简要总结
This is a double blind, randomised, placebo-controlled, parallel-group trial to evaluate the effect of Maolactin FMR supplementation on chronic inflammation, mobility and muscle and joint pain in an otherwise healthy population of adults over 45 years old over 10 weeks with 8 weeks supplementation.
This is PART B of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults 45 years and older
- •Generally healthy
- •BMI 25.0 - 35.0 kg/m2
- •C-reactive protein (CRP) equal to or greater than 2.0 mg/L
- •Feel pain or discomfort in joints/muscle for at least 3 months
- •Able to provide informed consent
- •Agree not to change current diet and/or exercise frequency or intensity during study period
- •Agree to not participate in another clinical trial while enrolled in this trial
排除标准
- •Serious illness(1) e.g., mood disorders such as depression, anxiety or bipolar disorder, neurological disorders such as MS, kidney disease, liver disease or heart conditions
- •Unstable illness(2) e.g., diabetes and thyroid gland dysfunction
- •Unstable intake of any medication or supplement(3)
- •Acute injuries on reporting area
- •Current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years
- •Currently taking Coumadin (Warfarin), Heparin, Dalteparin, Enoxaparin or other anticoagulation therapy including low dose aspirin
- •Receiving medications known to affect inflammation such as steroids
- •Active smokers, nicotine use or drug (prescription or illegal substances) abuse
- •Chronic past and/or current alcohol use (>21 alcoholic drinks per week)
- •Pregnant or lactating women
- •Allergic to any of the ingredients in active or placebo formula
- •Participants who are currently participating in any other clinical trial or who have participated in any other clinical trial during the past 1 month
- •Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
- •A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.
- •An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity.
- •An unstable intake is any dose that has changed by more than 10% of the previous dose in the past 4-weeks
研究组 & 干预措施
Maolactin
Experimental
2 capsules containing a total of 500 mg/day active proteins taken once daily before the morning meal
干预措施: Maolactin (Drug)
Maltodextrin
Placebo Comparator
2 capsules containing maltodextrin (0mg/day active proteins) taken once daily before the morning meal
干预措施: Maltodextrin (Drug)
结局指标
主要结局
Change in Inflammatory status
时间窗: Baseline and Week 8
Change in Inflammatory status as assessed by C-reactive protein (CRP) via blood test
次要结局
- Change in Weight(Baseline and Week 8)
- Change in Body Mass Index (BMI)(Baseline and Week 8)
- Change in Musculoskeletal Health Questionnaire (MSK-HQ)(Baseline, Week 4 and Week 8)
- Change in Visual Analogue Scale (VAS) Muscle Pain(Baseline, Week 4 and Week 8)
- Change in Visual Analogue Scale (VAS) Pain(Baseline, Week 4 and Week 8)
- Change in Visual Analogue Scale (VAS) Fatigue(Baseline, Week 4 and Week 8)
- Change in Visual Analogue Scale (VAS) Mobility(Baseline, Week 4 and Week 8)
- Change in Visual Analogue Scale (VAS) Stiffness(Baseline, Week 4 and Week 8)
- Change in Multidimensional Fatigue Inventory (MFI)(Baseline, Week 4 and Week 8)
- Change in Blood Pressure (BP)(Baseline and Week 8)
- Change in Heart Rate (HR)(Baseline and Week 8)
- Change in Oxygen Saturation(Baseline and Week 8)
- Change in Cytokines(Baseline and Week 8)
- Change in Monocyte Chemotactic Protein-1 (MCP-1)(Baseline and Week 8)
- Change in Nuclear Factor KappaB (NF-kB)(Baseline and Week 8)
- Change in P-selectin(Baseline and Week 8)
- Change in E-selectin(Baseline and Week 8)
- Change in Matrix Metalloproteinase-3 (MMP3)(Baseline and Week 8)
- Change in Cartilage Oligomeric Matrix Protein (COMP/thrombospondin-5)(Baseline and Week 8)
- Change in Type II procollagen (CPII)(Baseline and Week 8)
- Change in Type II collagen (C2C)(Baseline and Week 8)
- Change in Creatine Kinase (CK)(Baseline and Week 8)
- Change in Myoglobin(Baseline and Week 8)
- Change in Full Blood Count (FBC)(Baseline and Week 8)
- Change in Platelet agglomeration(Baseline and Week 8)
- Change in Lipoprotein-associated phospholipase A2 (Lp-PLA2)(Baseline and Week 8)
- Change in Intercellular Cell Adhesion Molecule-1 (ICAM-1)(Baseline and Week 8)
- Change in Intercellular Cell Adhesion Molecule-2 (ICAM-2)(Baseline and Week 8)
- Change in Vascular Cell Adhesion Molecule-1 (VCAM-1)(Baseline and Week 8)
- Change in Vascular Cell Adhesion Molecule-2 (VCAM-2)(Baseline and Week 8)
- Change in Platelet Endothelial Cell Adhesion Molecule-1 (PECAM-1)(Baseline and Week 8)
- Change in Erythrocyte Sedimentation Rate (ESR)(Baseline and Week 8)
- Change in Lactate Dehydrogenase (LDH)(Baseline and Week 8)
- Change in P38 Mitogen-activated Protein Kinases (P38)(Baseline and Week 8)
- Change in Electrolytes and Liver Function Tests (E/LFT)(Baseline and Week 8)
- Change in 2 minute walk test(Baseline and Week 8)
- Change in sit-to-stand test(Baseline and Week 8)
- Change in Hand Grip Strength(Baseline and Week 8)
- Change in Adverse Events(Baseline to week 8)
- Change in Gastrointestinal Tolerance(1 week after starting product and Week 8)
研究者
研究点 (1)
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