Skeletal Muscle DamageNCT03934762
Aloe Vera Ointment Application and Skeletal Muscle Recovery
A study testing Natural Aloe Vera and Aloe vera soup in people with Skeletal Muscle Damage and Exercise-induced Aseptic Inflammation, run by University of Thessaly at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Skeletal Muscle Damage, Exercise-induced Aseptic Inflammation, Performance
- What is being tested?
- Natural Aloe Vera and Aloe vera soup
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteGreece
- Study dates
- 25 Apr 2019to 30 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Greece1 site
SmArT LABORATORY, SCHOOL OF PHYSICAL EDUCATION & SPORTS SCIENCES, UNIVERSITY OF THESSALY
Trikala, 42100
About this study
Official title: Effect of Aloe Vera Ointment Application on Muscle Damage and Performance Recovery Kinetics Following an Intense Eccentric Exercise Protocol: A Pilot Study.
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.
Read the 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.
- Being tested
- Placebo, Natural Aloe Vera, Aloe vera soup
- Keywords
- aseptic inflammation, muscle trauma, muscle strength, aloe vera
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboBiological
A placebo solution that will not include aloe vera will be applied on the quadriceps of one of the lower limbs.
Natural Aloe VeraBiological
Natural aloe vera solution including peel and leaf from aloe will be applied on the the quadriceps of one of the lower limbs.
Aloe vera soupBiological
Aloe vera solution including aloe vera soup will be applied on the the quadriceps of one of the lower limbs.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Biological: Aloe vera soup |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: At baseline, 1 hour post-exercise, 6 hours post-exercise and daily for 7 consecutive days post-exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study start25 Apr 2019
- Primary completion15 May 2019
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skeletal Muscle DamageStudies of the same condition, open and under way.
- More trials run by University of ThessalyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ioannis G. Fatouros, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03934762
- Sponsor's protocol ID
- ALOE VERA-PILOT STUDY-UTH
- Status last verified
- Apr 2019
- First submitted
- 26 Apr 2019
- Last updated
- 2 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aloe Vera Ointment Application on Muscle Damage and Performance Recovery Kinetics Following an Intense Eccentric Exercise Protocol: A Pilot Study.
- ClinicalTrials.gov ID
- NCT03934762
- Acronym / sponsor ID
- ALOE VERA-PILOT STUDY-UTH
- Keywords
- aseptic inflammation, muscle trauma, muscle strength, aloe vera
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 25 Apr 2019 (actual)
- Primary completion
- 15 May 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 2 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Active comparator | Biological: PlaceboA 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. |
| Natural aloe vera | Experimental | Biological: Natural Aloe VeraA 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. |
| Aloe vera soup | Experimental | Biological: Aloe vera soupAn 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboA placebo solution that will not include aloe vera will be applied on the quadriceps of one of the lower limbs. | Biological | Placebo |
| Natural Aloe VeraNatural aloe vera solution including peel and leaf from aloe will be applied on the the quadriceps of one of the lower limbs. | Biological | Natural aloe vera |
| Aloe vera soupAloe vera solution including aloe vera soup will be applied on the the quadriceps of one of the lower limbs. | Biological | Aloe vera soup |
Primary outcome
Change in creatine kinase activity in plasma
Time frame: At baseline, 1 hour post-exercise, 6 hours post-exercise and daily for 7 consecutive days post-exercise
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
Time frame: At baseline, 1 hour post-exercise, 6 hours post-exercise and daily for 7 consecutive days post-exercise
Maximal knee extensor concentric, eccentric and isometric peak torque will be measured on an isokinetic dynamometer.
Change in delayed onset of muscle soreness
Time frame: At baseline, 1 hour post-exercise, 6 hours post-exercise and daily for 7 consecutive days post-exercise
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Natural Aloe Vera and Aloe vera soup in people with Skeletal Muscle Damage and Exercise-induced Aseptic Inflammation, run by University of Thessaly at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in creatine kinase activity in plasma (time frame: At baseline, 1 hour post-exercise, 6 hours post-exercise and daily for 7 consecutive days post-exercise). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2020.