Pain, stiffness, range of motion, psychological mood state (wellbeing, mood, vigor) and cellular oxidation Not Applicable Pain Stiffness Range of motion Psychological mood state (wellbeing, mood, vigor) Cellular oxidation
Conditions
Interventions
30 participants will be randomly allocated to the active group or the placebo group. This study is a double-blind study.
Participants in the active group will receive 400 mg AmLexin (A
Sponsors
Unigen Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: 1. Range of motions (ROM), assessed using digital inclinometry 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) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Oxidation-reduction potential (ORP), assessed using the Luoxis' proprietary RedoxSYS Diagnostic System at the baseline and 7 days post-marathon 2. Profile of mood states, assessed using the Profile of Mood States Survey (POMS) at the baseline and 1 and 7 days post-marathon | — |
Countries
United States of America
Outcome results
None listed