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临床试验/NCT06436781
NCT06436781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

RDC Clinical Pty Ltd1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2024年9月12日最近更新:
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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
33
试验地点
1
主要终点
Change in post exercise muscle breakdown
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

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 post exercise inflammation, exercise recovery and muscle fatigue and pain in an otherwise healthy population of adults 18-65 years old over 10 weeks with 8 weeks of supplementation.

This is PART A 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
18 Years 至 65 Years（Adult, Older Adult）
性别
All
接受健康志愿者
是

入选标准

  • •Adults 18-65 years old
  • •Generally healthy
  • •BMI 19.0 - 29.9 kg/m2
  • •Able to provide informed consent
  • •Generally active, low to moderately trained (with a minimum of 1 resistance exercise sessions per week)
  • •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

  • •Undertaking high intensity exercise training and or undertaking more than 3 days of resistance training per week.
  • •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 post exercise muscle breakdown

时间窗: Baseline (Pre-exercise and 0, 1, 2, 24 and 48 hours post exercise) and Week 8 (Pre-exercise and 0, 1, 2, 24 and 48 hours post exercise)

Change in post exercise muscle breakdown as assessed by creatine kinase (CK) via blood test

次要结局

  • Change in Blood Pressure (BP)(Baseline and Week 8)
  • Change in Heart Rate (HR)(Baseline (Time 0 and every 5 minutes until return to baseline) and Week 8 (Time 0 and every 5 minutes until return to baseline))
  • Change in Visual Analogue Scale (VAS) Muscle Pain(Baseline (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)) and Week 8 (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)))
  • Change in Visual Analogue Scale (VAS) Pain(Baseline (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)) and Week 8 (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)))
  • Change in Visual Analogue Scale (VAS) Mobility(Baseline (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)) and Week 8 (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)))
  • Change in Visual Analogue Scale (VAS) Stiffness(Baseline (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)) and Week 8 (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)))
  • Change in Weight(Baseline and Week 8)
  • Change in Oxygen Saturation(Baseline and Week 8)
  • Change in Cytokines(Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post))
  • Change in Nuclear Factor KappaB (NF-kB)(Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post))
  • Change in P-selectin(Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post))
  • Change in C-reactive protein (CRP)(Baseline (Pre-exercise and 0, 1, 2, 24 and 48 hours post exercise) and Week 8 (Pre-exercise and 0, 1, 2, 24 and 48 hours post exercise))
  • Change in Number of Repetitions to Fatigue(Baseline (Session 1 and Session 2 (+24 hours)) and Week 8 (Session 1, Session 2 (+24 hours))
  • Change in Adverse Events(8 week period from enrolment to participant conclusion)
  • Change in Gastrointestinal Tolerance(1 week after starting product)
  • Change in Body Mass Index (BMI)(Baseline and Week 8)
  • Change in Musculoskeletal Health Questionnaire (MSK-HQ)(Baseline (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)) and Week 8 (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)))
  • Change in Multidimensional Fatigue Inventory (MFI)(Baseline (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)) and Week 8 (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)))
  • Change in Visual Analogue Scale (VAS) Fatigue(Baseline (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)) and Week 8 (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)))
  • Change in The Perceived Recovery Status Scale (PRSS)(Baseline (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)) and Week 8 (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)))
  • Change in E-selectin(Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post))
  • Change in Lipoprotein-associated Phospholipase A2 (Lp-PLA2)(Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post))
  • Change in Intercellular Cell Adhesion Molecule-1 (ICAM-1)(Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post))
  • Change in Vascular Cell Adhesion Molecule-1 (VCAM-1)(Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post))
  • Change in Platelet Endothelial Cell Adhesion Molecule-1 (PECAM-1)(Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post))
  • Change in Erythrocyte Sedimentation Rate (ESR)(Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post))
  • Change in Lactic acid(Baseline (Pre-exercise and 0, 1, 2, 24 and 48 hours post exercise) and Week 8 (Pre-exercise and 0, 1, 2, 24 and 48 hours post exercise))
  • Change in myoglobin(Baseline (Pre-exercise and 0, 1, 2, 24 and 48 hours post exercise) and Week 8 (Pre-exercise and 0, 1, 2, 24 and 48 hours post exercise))
  • Change in 1 Repetition Max (1-RM)(Baseline (Session 1 and Session 2 (+24 hours)) and Week 8 (Session 1, Session 2 (+24 hours)))
  • Change in Electrolytes and Liver Function Tests (E/LFT)(Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post))
  • Change in Intercellular Cell Adhesion Molecule-2 (ICAM-2)(Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post))
  • Change in P38 Mitogen-activated Protein Kinases (P38)(Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post))
  • Change in Lactate Dehydrogenase (LDH)(Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post))
  • Change in diet(Baseline and Week 8)
  • Change in Hand Grip Strength(Baseline (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)) and Week 8 (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)))
  • Change in BORG Perception of intensity (RPE)(Baseline (Session 1 and Session 2 (+24 hours)) and Week 8 (Session 1, Session 2 (+24 hours))

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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