Joint PainPhase 2Exten(d)NCT04150211

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

A Phase 2 study of Joint Pain and Knee Inflammation, run by Natural Origins at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 40 to 60 years, men onlyHealthy volunteers can take part
Conditions the study is for: Joint Pain, Knee Inflammation, Biomechanical; Lesion
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 33 participants
Where: 1 siteSpain
Study dates: 10 Sep 2018to 14 Dec 2018
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 60 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site

Universidad Politecnica de Madrid
Madrid, 28040

Other trials in Spain

About this study

Official title: 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.

Read the 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.

Conditions: Joint Pain, Knee Inflammation, Biomechanical; Lesion
Being tested: Polyherbal Exten(d) vs Placebo
Keywords: Harpagophytum, Zingiber officinae, Bixa orellana, Joint pain, Inflammation, Biomechanics
Medical subject headings: Arthralgia, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Polyherbal Exten(d) vs PlaceboDietary supplement
Supplementation during 4 weeks

Study groups in NCT04150211
Study group	Role	What they receive
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. Receives: 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. Receives: Dietary Supplement: Polyherbal Exten(d) vs Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
Measured: Changes from baseline running technique at week 4

Secondary outcomes (6)

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)
Measured: Changes from baseline at week 4
Impedancemetric variables
Body composition assessment (DXA): fat mass, lean mass, total water (%), muscle mass (kg)
Measured: 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
Measured: Changes from baseline at week 4
knee pain perception
Visual Analogue Scale pain perception
Measured: Changes from baseline at week 4
Biochemical variables
Changes in metabolic biomarkers: total Bilirubin, Urea, Albumin, Creatinin, Cholesterol, HDL, LDL, TG
Measured: Changes from baseline at week 4
Hematological variables
Changes in the hematological profile
Measured: Changes from baseline at week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Sep 201814 Dec 2018

First posted4 Nov 2019
Study start10 Sep 2018
Primary completion8 Oct 2018
Study completion14 Dec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Joint PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Single dose, Randomized, triple Blinded, Placebo-controlled Study
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04150211
Sponsor's protocol ID: Nat.Origins-Exten(d)-2019
Acronym: Exten(d)
Status last verified: Oct 2019
First submitted: 16 Oct 2019
Last updated: 4 Nov 2019
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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.
PubMed 34067240

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Dietary Supplementation With Exten(d) Blend on Training Ability in Recreational Runners: A Pilot Randomized, Triple-blind, Placebo Controlled Trial
ClinicalTrials.gov ID: NCT04150211
Acronym / sponsor ID: Exten(d) / Nat.Origins-Exten(d)-2019
Conditions: Joint Pain, Knee Inflammation, Biomechanical; Lesion
Keywords: Harpagophytum, Zingiber officinae, Bixa orellana, Joint pain, Inflammation, Biomechanics
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 33 participants (actual)
Lead sponsor: Natural OriginsIndustry (pharma, biotech, devices)
Collaborators: Universidad Politecnica de Madrid
Study start: 10 Sep 2018 (actual)
Primary completion: 8 Oct 2018 (actual)
Study completion: 14 Dec 2018 (actual)
First posted: 4 Nov 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Triple-blind, randomized, placebo-controlled, parallel group, pilot safety, and efficacy study.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2
Model description: Single dose, Randomized, triple Blinded, Placebo-controlled Study

Arm	Type	Receives
Exten(d)	Active comparator	Dietary Supplement: Polyherbal Exten(d) vs PlaceboSubjects have to take Exten(d) capsules (3 times a day, total 2 g/day) during breakfast, lunch and diner, during 4 weeks.
Placebo	Placebo comparator	Dietary Supplement: Polyherbal Exten(d) vs PlaceboSubjects have to take Placebo capsules (3 times a day, total 2 g/day) during breakfast, lunch and diner, during 4 weeks.

Who may qualify

Ages: 40 to 60 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Polyherbal Exten(d) vs PlaceboSupplementation during 4 weeks	Dietary supplement	Exten(d), Placebo

Primary outcome

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.
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

6 secondary outcomes

Enzymes safety variables
Time frame: Changes from baseline at week 4
Impedancemetric variables
Time frame: Changes from baseline at week 4
VO2max
Time frame: Changes from baseline at week 4
knee pain perception
Time frame: Changes from baseline at week 4
Biochemical variables
Time frame: Changes from baseline at week 4
Hematological variables
Time frame: Changes from baseline at week 4

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2019.
Derived from this study: PubMed 34067240Gonzalez-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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marcela Gonzalez-Gross, phD principal investigator

INEF- Universidad Politecnica de Madrid

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study of Joint Pain and Knee Inflammation, run by Natural Origins at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effects of Exten(d) herbal blend on knee and popliteus inflammation (time frame: Changes from baseline at week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04150211, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2019.