Effects of AmLexin (Acacia Catechu and Morus Alba) on Redox and Subjective Pain in Healthy Physically Active Adults
Not Applicable
Completed
- Conditions
- Pain, stiffness, range of motion, psychological mood state (wellbeing, mood, vigor) and cellular oxidationNot ApplicablePain Stiffness Range of motion Psychological mood state (wellbeing, mood, vigor) Cellular oxidation
- Registration Number
- ISRCTN10377494
- Lead Sponsor
- nigen Inc.
- Brief Summary
2018 Results article in https://pubmed.ncbi.nlm.nih.gov/30661328/ (added 07/12/2021)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
1. Aged 18-70
2. BMI < 30 kg/m²
3. Healthy and active
4. No recurrent pain or limitations in range of motion
5. Ability to complete training for, and complete, a 13.1 mile half-marathon run
6. Willing to consume dietary supplements under investigation
7. Willing to undertake all protocol measurements and training regimens
8. Ability to understand and sign the informed consent form
Exclusion Criteria
1. Recurrent pain, use of pain medications or pain supplements
2. Pregnant or breastfeeding women
3. Inability to complete prescribed training regimen
4. Current use of other pain support supplement or over-the-counter drug
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> The following are assessed at the baseline, weekly during the training regimen (weeks 1, 2, 3, 4, 5, 6, 7 and 8), and daily for a week post half-marathon:<br> 1. Range of motions (ROM), assessed using digital inclinometry<br> 2. Pain, stiffness and activities of daily living, assessed using a visual analogue scale (VAS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)<br>
- Secondary Outcome Measures
Name Time Method <br> 1. Oxidation-reduction potential (ORP), assessed using the Luoxis' proprietary RedoxSYS Diagnostic System at the baseline and 7 days post-marathon<br> 2. Profile of mood states, assessed using the Profile of Mood States Survey (POMS) at the baseline and 1 and 7 days post-marathon<br>