Clinical trial NCT04150211: Effects of Exten(d) Supplementation on Training Ability in Recreational Runners
Official title: Effects of Dietary Supplementation With Exten(d) Blend on Training Ability in Recreational Runners: A Pilot Randomized, Triple-blind, Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Joint Pain
Knee Inflammation
Biomechanical; Lesion
Keywords: Harpagophytum
Zingiber officinae
Bixa orellana
Joint pain
Inflammation
Biomechanics
Lead sponsor: Natural Origins
Sponsor class: INDUSTRY
Collaborators: name: Universidad Politecnica de Madrid
First posted: 2019-11-04
Enrollment: 33
Sex: MALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single dose, Randomized, triple Blinded, Placebo-controlled Study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Effects of Exten(d) herbal blend on knee and popliteus inflammation
timeFrame: Changes from baseline at week 4
measure: Effects of Exten(d) on biomechanicals running technique
timeFrame: Changes from baseline running technique at week 4
Secondary outcomes:
measure: Enzymes safety variables
timeFrame: Changes from baseline at week 4
measure: Impedancemetric variables
timeFrame: Changes from baseline at week 4
measure: VO2max
timeFrame: Changes from baseline at week 4
measure: knee pain perception
timeFrame: Changes from baseline at week 4
measure: Biochemical variables
timeFrame: Changes from baseline at week 4
measure: Hematological variables
timeFrame: Changes from baseline at week 4
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Universidad Politecnica de Madrid
Study officials:
affiliation: INEF- Universidad Politecnica de Madrid
name: Marcela Gonzalez-Gross, phD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.