Universidad Politecnica de Madrid
Madrid, 28040, Spain
NCT Number: NCT04150211
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.
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Notify Me40 year–60 year
Male
Interventional
Phase 2
Madrid, 28040, Spain
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Supplementation during 4 weeks
Time frame: 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.
Time frame: Changes from baseline running technique at week 4
Biomechanics techniques assessment by VICON technology before and after the incremental test to exhaustion
Time frame: 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)
Time frame: Changes from baseline at week 4
Body composition assessment (DXA): fat mass, lean mass, total water (%), muscle mass (kg)
Time frame: 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
Time frame: Changes from baseline at week 4
Visual Analogue Scale pain perception
Time frame: Changes from baseline at week 4
Changes in metabolic biomarkers: total Bilirubin, Urea, Albumin, Creatinin, Cholesterol, HDL, LDL, TG
Time frame: Changes from baseline at week 4
Changes in the hematological profile
Natural Origins
Industry
Effects of Dietary Supplementation With Exten(d) Blend on Training Ability in Recreational Runners: A Pilot Randomized, Triple-blind, Placebo Controlled Trial
Acronym: Exten(d)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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