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

Natural Origins33 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Joint Pain Knee Inflammation Biomechanical; Lesion

Interventions

Polyherbal Exten(d) vs PlaceboDIETARY_SUPPLEMENT

Supplementation during 4 weeks

Eligibility

Sex: MALEMin age: 40 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Universidad Politecnica de Madrid

Madrid, Spain

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: Changes from baseline running technique at week 4

Secondary Outcomes

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)

Time frame: Changes from baseline at week 4

Impedancemetric variables

Body composition assessment (DXA): fat mass, lean mass, total water (%), muscle mass (kg)

Time frame: 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

Time frame: Changes from baseline at week 4

knee pain perception

Visual Analogue Scale pain perception

Time frame: Changes from baseline at week 4

Biochemical variables

Changes in metabolic biomarkers: total Bilirubin, Urea, Albumin, Creatinin, Cholesterol, HDL, LDL, TG

Data from ClinicalTrials.gov

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