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Aloe Vera Ointment Application and Skeletal Muscle Recovery

Primary Purpose

Skeletal Muscle Damage, Exercise-induced Aseptic Inflammation, Performance

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Placebo
Natural Aloe Vera
Aloe vera soup
Sponsored by
University of Thessaly
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skeletal Muscle Damage focused on measuring aseptic inflammation, muscle trauma, muscle strength, aloe vera

Eligibility Criteria

18 Years - 25 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Placebo

Natural aloe vera

Aloe vera soup

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
Change in performance of knee extensor muscles
Maximal knee extensor concentric, eccentric and isometric peak torque will be measured on an isokinetic dynamometer.
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.

Secondary Outcome Measures

Full Information

First Posted
April 26, 2019
Last Updated
December 30, 2019
Sponsor
University of Thessaly
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1. Study Identification

Unique Protocol Identification Number
NCT03934762
Brief Title
Aloe Vera Ointment Application and Skeletal Muscle Recovery
Official Title
Effect of Aloe Vera Ointment Application on Muscle Damage and Performance Recovery Kinetics Following an Intense Eccentric Exercise Protocol: A Pilot Study.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
April 25, 2019 (Actual)
Primary Completion Date
May 15, 2019 (Actual)
Study Completion Date
May 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Thessaly

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
For the purpose of study, ten male participants will be included in a pilot clinical trial. Initially, participants will undergo a baseline testing including assessment of body height, body mass and body composition, isokinetic evaluation of isometric, concentric and eccentric muscle strength of quadriceps, determination of VO2max, evaluation of DOMS level and resting blood sampling for the measurement of CK. Participants will be also provided with 7-day diet recalls and will be taught by a trained dietitian on how to adjust food/liquid portions and sizes and how to complete diet recalls (1 recall/day over a 7-day period). After baseline testing, subjects will participate in two trials, in a randomized, double-blind repeated measures design. In the first trial they will execute a bilateral eccentric exercise protocol. Immediately after the exercise protocol and daily for 7 consecutive days, will be applied transdermal treatment with placebo (Control) in one leg and with natural aloe vera (Experimental, aloe vera peel and leaf) in the other. Following a 7-day wash-out period the second trial will be conducted. Participants will execute the same eccentric exercise protocol, but they will be treated with either placebo (Control) or aloe vera soup (Experimental). The selection of the treatment for each leg will be randomly selected. In both trials, assessment of DOMS and strength (isometric, concentric and eccentric) in both legs and blood sampling (for the measurement of CK) will be performed at 1h and 6h post-exercise as well as daily for 7 consecutive days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skeletal Muscle Damage, Exercise-induced Aseptic Inflammation, Performance
Keywords
aseptic inflammation, muscle trauma, muscle strength, aloe vera

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Natural aloe vera
Arm Type
Experimental
Arm Description
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.
Arm Title
Aloe vera soup
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
A placebo solution that will not include aloe vera will be applied on the quadriceps of one of the lower limbs.
Intervention Type
Biological
Intervention Name(s)
Natural Aloe Vera
Intervention Description
Natural aloe vera solution including peel and leaf from aloe will be applied on the the quadriceps of one of the lower limbs.
Intervention Type
Biological
Intervention Name(s)
Aloe vera soup
Intervention Description
Aloe vera solution including aloe vera soup will be applied on the the quadriceps of one of the lower limbs.
Primary Outcome Measure Information:
Title
Change in creatine kinase activity in plasma
Description
Creatine kinase activity will be measured in plasma by utilizing a Clinical Chemistry Analyzer and commercially available kits.
Time Frame
At baseline, 1 hour post-exercise, 6 hours post-exercise and daily for 7 consecutive days post-exercise
Title
Change in performance of knee extensor muscles
Description
Maximal knee extensor concentric, eccentric and isometric peak torque will be measured on an isokinetic dynamometer.
Time Frame
At baseline, 1 hour post-exercise, 6 hours post-exercise and daily for 7 consecutive days post-exercise
Title
Change in delayed onset of muscle soreness
Description
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.
Time Frame
At baseline, 1 hour post-exercise, 6 hours post-exercise and daily for 7 consecutive days post-exercise

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
SmArT LABORATORY, SCHOOL OF PHYSICAL EDUCATION & SPORTS SCIENCES, UNIVERSITY OF THESSALY
City
Trikala
ZIP/Postal Code
42100
Country
Greece

12. IPD Sharing Statement

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Aloe Vera Ointment Application and Skeletal Muscle Recovery

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