Biomechanical; Lesion, Joint Pain, Knee Inflammation
Conditions
Keywords
Harpagophytum, Zingiber officinae, Bixa orellana, Joint pain, Inflammation, Biomechanics
Brief summary
The study will assess running biomechanics and joint inflammation of physically active males between 40 and 60 years of age, mainly runners, suffering from knee joint inflammation and pain after training. Participants were split into two groups, intervention and placebo, to evaluate the safety and efficacy of Exten(d) supplementation during 4 weeks.
Detailed description
Triple-blind, randomized, placebo-controlled, parallel group, pilot safety, and efficacy study. 30 healthy physically active males (40 to 60 years old) suffering from knee joint inflammation and pain after training were randomly assigned to the Exten(d) or Placebo group. During the first visit and after 4 weeks supplementation (either 2 g daily of Exten(d) capsules or placebo capsules) the participants were subjected to a three-stage exercise session: (i) running biomechanical assessment, (ii) exercise physiology maximal effort test and (iii) running biomechanical assessment after the incremental exercise to exhaustion. The volunteers have been assessed to determine: (1) inflammation by I-R thermography and pain perception, (2) running technics though biomechanic analysis and (3) performance.
Interventions
DIETARY_SUPPLEMENTPolyherbal Exten(d) vs Placebo
Supplementation during 4 weeks
Sponsors
Universidad Politecnica de Madrid
Natural Origins
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Each pill bottle was assigned a five characters numeric code and a letter (A or B). Then, the codes were randomly distributed to the participants. Once the study finished, an external person to the study revealed the placebo and controlled group for each letter.
Intervention model description
Single dose, Randomized, triple Blinded, Placebo-controlled Study
Eligibility
Sex/Gender
MALE
Age
40 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Male recreational runners who run for at least 150 minutes per week divided into two or more sessions. * The participants were expected to describe some degree of knee inflammation and/or discomfort after training in order to be accepted. Knee discomfort was considered significant whenever a subject referred to a punctuation of ≥ 2 in a Visual Analogue Scale (VAS). * Agree not to initiate any new exercise or diet programs during the entire study period * Agree not to change their current diet or exercise program during the entire study period * Agree not to stretch, utilize ice massage, take anti-inflammatory medications (eg, aspirin, ibuprofen), or use any other treatment during the trial.
Exclusion criteria
* Use of anti-inflammatory medications or pain medications 1 week before the screening visit and during the study * Daily use of dietary supplements and herbal supplements beginning at the screening visit and during the study * Antibiotic use in the past 3 months * Chronic disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effects of Exten(d) herbal blend on knee and popliteus inflammation | Changes from baseline at week 4 | Knee and popliteus inflammation assessment by IR Thermography after the warm-up, after the first Biomechanical test, after the incremental test to exhaustion and after the second biomechanical test. |
| Effects of Exten(d) on biomechanicals running technique | Changes from baseline running technique at week 4 | Biomechanics techniques assessment by VICON technology before and after the incremental test to exhaustion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VO2max | Changes from baseline at week 4 | VO2max assessment during an incremental test to exhaustion on a computerized treadmill. Expired gases measurment by a Jaeger Oxycon Pro gas analyser during the incremental test |
| knee pain perception | Changes from baseline at week 4 | Visual Analogue Scale pain perception |
| Enzymes safety variables | Changes from baseline at week 4 | Blood based biomarkers assay for liver injury enzymes (Alanine transaminase GPT, Aspartate transaminase GOT, Gamma glutamyl-transpeptidase GGT) and muscle injury CPK (IU/L) |
| Hematological variables | Changes from baseline at week 4 | Changes in the hematological profile |
| Biochemical variables | Changes from baseline at week 4 | Changes in metabolic biomarkers: total Bilirubin, Urea, Albumin, Creatinin, Cholesterol, HDL, LDL, TG |
| Impedancemetric variables | Changes from baseline at week 4 | Body composition assessment (DXA): fat mass, lean mass, total water (%), muscle mass (kg) |
Countries
Spain
Outcome results
None listed