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| Name | Class |
|---|---|
| Universidad Politecnica de Madrid | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exten(d) | Active Comparator | Subjects have to take Exten(d) capsules (3 times a day, total 2 g/day) during breakfast, lunch and diner, during 4 weeks. |
|
| Placebo | Placebo Comparator | Subjects have to take Placebo capsules (3 times a day, total 2 g/day) during breakfast, lunch and diner, during 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polyherbal Exten(d) vs Placebo | Dietary Supplement | Supplementation during 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effects of Exten(d) herbal blend on knee and popliteus inflammation | 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. | Changes from baseline at week 4 |
| Effects of Exten(d) on biomechanicals running technique | Biomechanics techniques assessment by VICON technology before and after the incremental test to exhaustion | Changes from baseline running technique at week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Enzymes safety variables | Blood based biomarkers assay for liver injury enzymes (Alanine transaminase GPT, Aspartate transaminase GOT, Gamma glutamyl-transpeptidase GGT) and muscle injury CPK (IU/L) | Changes from baseline at week 4 |
| Impedancemetric variables |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marcela Gonzalez-Gross, phD | INEF- Universidad Politecnica de Madrid | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad Politecnica de Madrid | Madrid | 28040 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34067240 | Derived | Gonzalez-Gross M, Quesada-Gonzalez C, Rueda J, Sillero-Quintana M, Issaly N, Diaz AE, Gesteiro E, Escobar-Toledo D, Torres-Peralta R, Roller M, Guadalupe-Grau A. Analysis of Effectiveness of a Supplement Combining Harpagophytum procumbens, Zingiber officinale and Bixa orellana in Healthy Recreational Runners with Self-Reported Knee Pain: A Pilot, Randomized, Triple-Blind, Placebo-Controlled Trial. Int J Environ Res Public Health. 2021 May 22;18(11):5538. doi: 10.3390/ijerph18115538. |
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| ID | Term |
|---|---|
| D018771 | Arthralgia |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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Single dose, Randomized, triple Blinded, Placebo-controlled Study
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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.
Body composition assessment (DXA): fat mass, lean mass, total water (%), muscle mass (kg) |
| Changes from baseline at week 4 |
| VO2max | 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 | Changes from baseline at week 4 |
| knee pain perception | Visual Analogue Scale pain perception | Changes from baseline at week 4 |
| Biochemical variables | Changes in metabolic biomarkers: total Bilirubin, Urea, Albumin, Creatinin, Cholesterol, HDL, LDL, TG | Changes from baseline at week 4 |
| Hematological variables | Changes in the hematological profile | Changes from baseline at week 4 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |