Effects of Exten(d) Supplementation on Training Ability in Recreational Runners

Study Overview
=================
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.

Official Title
-----------------
Effects of Dietary Supplementation With Exten(d) Blend on Training Ability in Recreational Runners: A Pilot Randomized, Triple-blind, Placebo Controlled Trial

Conditions
-----------------
Joint Pain, Knee Inflammation, Biomechanical; Lesion

Intervention / Treatment
-----------------
* Dietary Supplement: Polyherbal Exten(d) vs Placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single dose, Randomized, triple Blinded, Placebo-controlled Study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Exten(d)<br>Subjects have to take Exten(d) capsules (3 times a day, total 2 g/day) during breakfast, lunch and diner, during 4 weeks. | Dietary Supplement: Polyherbal Exten(d) vs Placebo<br>* Supplementation during 4 weeks<br>|
| Placebo Comparator: Placebo<br>Subjects have to take Placebo capsules (3 times a day, total 2 g/day) during breakfast, lunch and diner, during 4 weeks. | Dietary Supplement: Polyherbal Exten(d) vs Placebo<br>* Supplementation during 4 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Harpagophytum, Zingiber officinae, Bixa orellana, Joint pain, Inflammation, Biomechanics