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

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

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.

Study Overview

• Status: Completed
• Conditions: Joint Pain; Biomechanical; Lesion; Knee Inflammation
• Intervention / Treatment: Dietary supplement: Polyherbal Exten(d) vs Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 2

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Universidad Politécnica de Madrid

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Exten(d); 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; Supplementation during 4 weeks
Placebo Comparator: Placebo; 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; Supplementation during 4 weeks

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

Collaborators and Investigators

• Sponsor: Natural Origins
• Collaborators: Universidad Politecnica de Madrid
• Investigators: Principal Investigator: Marcela Gonzalez-Gross, phD, INEF- Universidad Politecnica de Madrid

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2018
• Primary Completion (Actual): October 8, 2018
• Study Completion (Actual): December 14, 2018

Study Registration Dates

• First Submitted: October 16, 2019
• First Submitted That Met QC Criteria: October 31, 2019
• First Posted (Actual): November 4, 2019

Study Record Updates

• Last Update Posted (Actual): November 4, 2019
• Last Update Submitted That Met QC Criteria: October 31, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Inflammation; Biomechanics; Joint pain; Bixa orellana; Harpagophytum; Zingiber officinae
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Inflammation
• Other Study ID Numbers: Nat.Origins-Exten(d)-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No