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

Natural Origins

Status and phase: Completed; Phase 2

Conditions: Joint Pain; Knee Inflammation; Biomechanical; Lesion

Treatments: Dietary Supplement: Polyherbal Exten(d) vs Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04150211

Nat.Origins-Exten(d)-2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: Male

Ages: 40 to 60 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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33 participants in 2 patient groups, including a placebo group

Exten(d)

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Polyherbal Exten(d) vs Placebo

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Polyherbal Exten(d) vs Placebo