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

NCT04150211 | Completed Phase 2

• 1 other identifier: Nat.Origins-Exten(d)-2019
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Joint Pain; Knee Inflammation; Biomechanical; Lesion

Keywords

Harpagophytum; Zingiber officinae; Bixa orellana; Joint pain; Inflammation; Biomechanics

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Enzymes safety variables

  Changes from baseline at week 4

• Impedancemetric variables

  Changes from baseline at week 4

• VO2max

  Changes from baseline at week 4

• knee pain perception

  Changes from baseline at week 4

• Biochemical variables

  Changes from baseline at week 4

Study Arms (2)

Exten(d)

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Polyherbal Exten(d) vs Placebo DIETARY_SUPPLEMENT

Supplementation during 4 weeks

Exten(d); Placebo

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Natural Origins: lead
• Universidad Politecnica de Madrid: collaborator

Study Sites (1)

Universidad Politecnica de Madrid

Madrid, 28040, Spain

Location

Related Publications (1)

• 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.

  PMID: 34067240 DERIVED

MeSH Terms

Conditions

Arthralgia; Inflammation

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Marcela Gonzalez-Gross, phD

  INEF- Universidad Politecnica de Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Each pill bottle was assigned a five characters numeric code and a letter (A or B). Then, the codes were randomly distributed to the participants. Once the study finished, an external person to the study revealed the placebo and controlled group for each letter.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffessor Doctor

Model Details: Single dose, Randomized, triple Blinded, Placebo-controlled Study

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: November 4, 2019
• Study Start: September 10, 2018
• Primary Completion: October 8, 2018
• Study Completion: December 14, 2018
• Last Updated: November 4, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)