跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
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:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
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)

Loading locations...

相似试验

已完成
3 期
Effect of Maolactin™ FMR on Exercise Recovery, Inflammation and Muscle Comfort in an Otherwise Healthy PopulationChronic InflammationMobilityMuscle PainJoint Pain
NCT06444763RDC Clinical Pty Ltd97
已完成
3 期
Effect of Maolactin on Gastrointestinal Tract (GIT) HealthGastrointestinal Dysfunction
NCT06104917RDC Clinical Pty Ltd91
已完成
不适用
Study on the Effect of Rhubarb Extract on Stool Frequency and Biological Markers of Intestinal Function in Seniors With Low DefecationConstipation - Functional
NCT05541991ortis45
已完成
3 期
L-citrulline and Metformin in Duchenne's Muscular DystrophyDuchenne's Muscular Dystrophy (DMD)
NCT01995032University Hospital, Basel, Switzerland47
已完成
不适用
Possible Effects of the Dietary Supplement Magnesium Compared to PlaceboHealth Promotion
NCT06332248Dan Hasson1,013