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Completed

NCT Number: NCT04150211

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

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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Key information

Age range

40 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Universidad Politecnica de Madrid

Madrid, 28040, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polyherbal Exten(d) vs Placebo

Dietary Supplement

Supplementation during 4 weeks

Primary outcomes

  1. Effects of Exten(d) herbal blend on knee and popliteus inflammation

    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.

  2. Effects of Exten(d) on biomechanicals running technique

    Time frame: Changes from baseline running technique at week 4

    Biomechanics techniques assessment by VICON technology before and after the incremental test to exhaustion

Secondary outcomes

  1. Enzymes safety variables

    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)

  2. Impedancemetric variables

    Time frame: Changes from baseline at week 4

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

  3. VO2max

    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

  4. knee pain perception

    Time frame: Changes from baseline at week 4

    Visual Analogue Scale pain perception

  5. Biochemical variables

    Time frame: Changes from baseline at week 4

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

  6. Hematological variables

    Time frame: Changes from baseline at week 4

    Changes in the hematological profile

Sponsors and collaborators

Lead sponsor

Natural Origins

Industry

Collaborators

  • Universidad Politecnica de Madrid

Registry information

Official study title

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)

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 4, 2019
Registry last updated
Nov 4, 2019

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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