Back to results

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

Primary Purpose

Joint Pain, Knee Inflammation, Biomechanical; Lesion

Status

Completed

Phase

Phase 2

Locations

Spain

Study Type

Interventional

Intervention

Polyherbal Exten(d) vs Placebo

About this trial

This is an interventional treatment trial for Joint Pain focused on measuring Harpagophytum, Zingiber officinae, Bixa orellana, Joint pain, Inflammation, Biomechanics

Eligibility Criteria

40 Years - 60 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Universidad Politecnica de Madrid

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Exten(d)

Placebo

Arm Description

Subjects have to take Exten(d) capsules (3 times a day, total 2 g/day) during breakfast, lunch and diner, during 4 weeks.

Subjects have to take Placebo capsules (3 times a day, total 2 g/day) during breakfast, lunch and diner, during 4 weeks.

Outcomes

Primary Outcome Measures

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.

Effects of Exten(d) on biomechanicals running technique

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

Secondary Outcome Measures

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)

Impedancemetric variables

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

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

knee pain perception

Visual Analogue Scale pain perception

Biochemical variables

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

Hematological variables

Changes in the hematological profile

Full Information

NCT ID

NCT04150211

First Posted

October 16, 2019

Last Updated

October 31, 2019

Sponsor

Natural Origins

Collaborators

Universidad Politecnica de Madrid

1. Study Identification

Unique Protocol Identification Number

NCT04150211

Brief Title

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

Acronym

Exten(d)

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Completed

Study Start Date

September 10, 2018 (Actual)

Primary Completion Date

October 8, 2018 (Actual)

Study Completion Date

December 14, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Natural Origins

Collaborators

Universidad Politecnica de Madrid

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Joint Pain, Knee Inflammation, Biomechanical; Lesion

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Single dose, Randomized, triple Blinded, Placebo-controlled Study

Masking

ParticipantInvestigatorOutcomes Assessor

Masking Description

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.

Allocation

Randomized

Enrollment

33 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Exten(d)

Arm Type

Active Comparator

Arm Description

Subjects have to take Exten(d) capsules (3 times a day, total 2 g/day) during breakfast, lunch and diner, during 4 weeks.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Subjects have to take Placebo capsules (3 times a day, total 2 g/day) during breakfast, lunch and diner, during 4 weeks.

Intervention Type

Dietary Supplement

Intervention Name(s)

Polyherbal Exten(d) vs Placebo

Intervention Description

Supplementation during 4 weeks

Primary Outcome Measure Information:

Title

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

Description

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

Title

Effects of Exten(d) on biomechanicals running technique

Description

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 Outcome Measure Information:

Title

Enzymes safety variables

Description

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

Title

Impedancemetric variables

Description

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

Time Frame

Changes from baseline at week 4

Title

VO2max

Description

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

Title

knee pain perception

Description

Visual Analogue Scale pain perception

Time Frame

Changes from baseline at week 4

Title

Biochemical variables

Description

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

Time Frame

Changes from baseline at week 4

Title

Hematological variables

Description

Changes in the hematological profile

Time Frame

Changes from baseline at week 4

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marcela Gonzalez-Gross, phD

Organizational Affiliation

INEF- Universidad Politecnica de Madrid

Official's Role

Principal Investigator

Facility Information:

Facility Name

Universidad Politecnica de Madrid

City

Madrid

ZIP/Postal Code

28040

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34067240

Citation

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.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs