NCT03934762

Brief Summary

Aloe vera, sometimes described as pharmaceutical aloe, is a flowering succulent plant with many therapeutic properties such as wound and burn wound healing, treatment of diabetes and reduction of blood lipid profile. These benefits have been primary attributed to its high content in polysaccharides, anthraquinones and lectins. However, aloe vera includes more than 200 ingredients and nutrients (i.e. vitamins, saponins, amino acids, anthraquinones, minerals and trace-elements, salicylic acid, saccharides, lignin, enzymes, sterols) the combination of which offers more powerful effects and health-related benefits compared to each one of them separately. Thus, based on the ingredients and nutrients included, it has been proposed that aloe vera may also offer anti-inflammatory, antioxidative, analgesic and anabolic benefits. Exercise training, especially when it is unaccustomed or characterized by increased intensity, results in skeletal muscle microtrauma accompanied by elevated plasma levels of Creatine Kinase (CK), increased sensation of muscle soreness (DOMS), reduced force generating capacity and marked declines in speed and agility. Both anti-inflammatory and antioxidative mechanisms in skeletal muscle are crucial for the termination of inflammatory response and muscle healing process following exercise-induced aseptic muscle injury and inflammation. Although, it has been proposed that ale vera may elicit anti-inflammatory and antioxidative activity, its effectiveness in alleviating exercise-induced skeletal muscle injury and its symptoms, has not been investigated yet. Therefore, the aim of the present pilot study is to examine the effect of transdermal aloe veral delivery on skeletal muscle damage symptoms following an intense eccentric exercise protocol.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 25, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 26, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 2, 2019

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2019

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2019

Completed
Last Updated

January 2, 2020

Status Verified

April 1, 2019

Enrollment Period

20 days

First QC Date

April 26, 2019

Last Update Submit

December 30, 2019

Conditions

Keywords

aseptic inflammationmuscle traumamuscle strengthaloe vera

Outcome Measures

Primary Outcomes (3)

  • Change in creatine kinase activity in plasma

    Creatine kinase activity will be measured in plasma by utilizing a Clinical Chemistry Analyzer and commercially available kits.

    At baseline, 1 hour post-exercise, 6 hours post-exercise and daily for 7 consecutive days post-exercise

  • Change in performance of knee extensor muscles

    Maximal knee extensor concentric, eccentric and isometric peak torque will be measured on an isokinetic dynamometer.

    At baseline, 1 hour post-exercise, 6 hours post-exercise and daily for 7 consecutive days post-exercise

  • Change in delayed onset of muscle soreness

    Muscle soreness will be assessed during palpation of the muscle belly and the distal region of relaxed quadriceps muscle following three repetitions of a full squat.

    At baseline, 1 hour post-exercise, 6 hours post-exercise and daily for 7 consecutive days post-exercise

Study Arms (3)

Placebo

ACTIVE COMPARATOR

A placebo solution will be applied on the quadriceps of one of the lower limbs immediately after the exercise protocol and daily for 7 consecutive days.

Biological: Placebo

Natural aloe vera

EXPERIMENTAL

A natural aloe vera solution (peel and leaf) will be applied on the quadriceps of one of the lower limbs immediately after the exercise protocol and daily for 7 consecutive days.

Biological: Natural Aloe Vera

Aloe vera soup

EXPERIMENTAL

An aloe vera soup solution will be applied on the quadriceps of one of the lower limbs immediately after the exercise protocol and daily for 7 consecutive days.

Biological: Aloe vera soup

Interventions

PlaceboBIOLOGICAL

A placebo solution that will not include aloe vera will be applied on the quadriceps of one of the lower limbs.

Placebo

Natural aloe vera solution including peel and leaf from aloe will be applied on the the quadriceps of one of the lower limbs.

Natural aloe vera
Aloe vera soupBIOLOGICAL

Aloe vera solution including aloe vera soup will be applied on the the quadriceps of one of the lower limbs.

Aloe vera soup

Eligibility Criteria

Age18 Years - 25 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Absence of musculoskeletal injury for at least 6 months prior to the study.
  • No consumption of performance-enhancing supplements or medication for at least 6 months prior to the study.
  • No consumption of anti-inflammatory and antioxidant supplements for at least 6 months prior to the study.
  • No participation in exercise including eccentric muscle contractions for at least 3 days prior to the study.

You may not qualify if:

  • Recent history of musculoskeletal injury.
  • Consumption of performance-enhancing supplements and medication.
  • Consumption of anti-inflammatory and antioxidant supplements (\> 6 months).
  • Participation in exercise including eccentric muscle contractions during the last 3 days prior to the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SmArT LABORATORY, SCHOOL OF PHYSICAL EDUCATION & SPORTS SCIENCES, UNIVERSITY OF THESSALY

Trikala, 42100, Greece

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 26, 2019

First Posted

May 2, 2019

Study Start

April 25, 2019

Primary Completion

May 15, 2019

Study Completion

May 30, 2019

Last Updated

January 2, 2020

Record last verified: 2019-04

Locations