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

Joint Pain Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04150211
• Other study ID #: Nat.Origins-Exten(d)-2019
• Status: Completed
• Phase: Phase 2
• Start date: September 10, 2018
• Est. completion date: December 14, 2018

Study information

• Verified date: October 2019
• Source: Natural Origins
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 14, 2018
• Est. primary completion date: October 8, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthralgia
• Biomechanical; Lesion
• Inflammation
• Joint Pain
• Knee Inflammation

Intervention

Dietary Supplement:
• Polyherbal Exten(d) vs Placebo
Supplementation during 4 weeks

Locations

Country	Name	City	State
Spain	Universidad Politecnica de Madrid	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Natural Origins	Universidad Politecnica de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

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