Healthy VolunteersNCT02923102
Effects of Recoverben® on Recovery After Exhaustive Exercise
A study testing Aloysia citriodora extract and Maltodextrin in people with Healthy Volunteers and Muscle Fatigue, run by Vital Solutions GmbH at 1 site in Germany.
Trial summary
The aim of the study is to investigate a pre and post workout supplementation (15 days) with Recoverben® , a Aloysia citriodora extract on recovery after exhaustive exercise. Effects will be investigated with 400mg Recoverben® and compared to placebo. Read more about this study
- Who is it for?
- Ages 22 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Muscle Fatigue, Muscle Soreness
- What is being tested?
- Aloysia citriodora extract and Maltodextrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2016to 15 Mar 2017
- 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 22 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is able and willing to sign the Informed Consent Form prior to screening evaluations
- Health volunteers: Subject is in good physical and mental health as established by medical his-tory, physical examination, electrocardiogram, vital signs, results of biochemistry and haematology
- Men and women
- Age ≥ 22 and ≤ 50 years
- BMI: 19-30 kg/m2
- Physically active 1-3 times per week
- Nonsmoker
- Able and willing to follow the study protocol procedures
Who cannot join
- Relevant history, presence of any medical disorder or chronic intake of medication/dietary supplements (e.g. polyphenols, anti-inflammatory or anti-oxidative drugs or supplements, antihyper-tensive drugs) potentially interfering with this study at screening.
- For this study clinically relevant abnormal laboratory, vital signs or physical findings at screening
- Diabetes or serious cardiovascular diseases
- Change of dietary habits within the 2 weeks prior to screening (for instance start of a diet high in vegetables and fruits (≥ 5 portions per day))
- Diet high in vegetables and fruits ≥ 5 portions per day
- Participants anticipating a change in their lifestyle or physical activity levels during the study.
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- Subjects not willing to abstain from intake of analgesic medication (e.g. Aspirin) 24 hours prior to visit 2 until visit 5.
- Subjects with history of drug, alcohol or other substances abuse, or other factors limiting their ability to co-operate during the study.
- Known hypersensitivity to the study preparation or to single ingredients
- Pregnant subject or subject planning to become pregnant during the study; breast-
- Known HIV-infection
- Known acute or chronic hepatitis B and C infection
- Blood donation within 4 weeks prior to visit 1 or during the study.
- Subject involved in any clinical or food study within the preceding month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Recoverben® on Recovery After Exhaustive Exercise in Healthy People - a Randomized, Double-blind, Placebo-controlled Study With Parallel Design
The aim of the study is to investigate a pre and post workout supplementation (15 days) with Recoverben® , a Aloysia citriodora extract on recovery after exhaustive exercise. Effects will be investigated with 400mg Recoverben® and compared to placebo.
Read the detailed description
The aim of the study is to investigate a pre and post workout supplementation (15 days) with Recoverben® , a Aloysia citriodora extract on recovery after exhaustive exercise. Effects will be investigated with 400mg Recoverben® and compared to placebo.
Targeted parameter will be determined at the beginning of the study and after supplementation, each. Parameter include maximal strength (MVC), muscle soreness (VAS), pain sensitivity (Algometry) and biomarkers (CK, IL-6, glutathione peroxidase).
- Conditions
- Healthy Volunteers, Muscle Fatigue, Muscle Soreness
- Being tested
- Aloysia citriodora extract, Maltodextrin
- Keywords
- Recovery, Muscle soreness, Lemon Verbena
- Medical subject headings
- Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aloysia citriodora extractDietary supplement
Also called Recoverben®
2 capsules with 200mg - daily dosage 400mg
MaltodextrinDietary supplement
Also called Placebo
2 capsules with 200mg - daily dosage 400mg
| Study group | Role | What they receive |
|---|---|---|
| Aloysia citriodora extract | Active comparator | Dietary Supplement: Aloysia citriodora extract Receives: Dietary Supplement: Aloysia citriodora extract |
| Placebo Formulation | Placebo comparator | Dietary Supplement: Maltodextrin (no active ingredient) Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of muscle soreness (VAS) over time
In the current study, pain following eccentric exercise will be assessed by using a 100 mm visual analogue scale after the subjects performing a standardized movement.
Measured: Chance over time after 10 days of supplementation (pre stress test and 3h, 24h, 48 h, 96h after stress test)
Secondary outcomes (7)
Monitoring of related adverse events
Reporting of adverse effects to evaluate tolerability
Measured: During study execution over 15 days
Change of maximal concentric strength/ maximal voluntary contraction (MVC) over time
Maximal concentric strength of the M. Quadriceps femoris will be assessed by measuring maximal isometric concentric strength using a dynamometer
Measured: Chance over time after 10 days of supplementation (pre stress test and 3h, 24h and 48 h after stress test)
Change of pressure pain (Algometry) over time
The threshold for pressure induced pain will be measured using an algometer.
Measured: Chance over time after 10 days of supplementation (pre stress test and 3h, 24h and 48 h after stress test)
Change of retrospective pain (Likert scale) over time
Evaluation of the perceived pain retrospectively by using the Likert scale for muscle soreness
Measured: Chance over time after 10 days of supplementation (pre stress test and 24h, 48h, 96h after stress test)
Change of creatine kinase over time
Measured: Chance over time after 10 days of supplementation (pre stress test and 3h, 24h and 48 h after stress test)
Change of of glutathione peroxidase over time
Measured: Chance over time after 10 days of supplementation (pre stress test and 24h and 48 h after stress test)
Change of interleukin-6 over time
Measured: Chance over time after 10 days of supplementation (pre stress test and 3h, 24h and 48 h after stress test)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study startOct 2016
- Primary completion15 Jan 2017
- Study completion15 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vital Solutions GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Claudia Reule, Dr., Study chair, BioTeSys GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02923102
- Sponsor's protocol ID
- BTS822/14
- Status last verified
- Nov 2017
- First submitted
- 28 Sep 2016
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Buchwald-Werner S, Naka I, Wilhelm M, Schutz E, Schoen C, Reule C. Effects of lemon verbena extract (Recoverben(R)) supplementation on muscle strength and recovery after exhaustive exercise: a randomized, placebo-controlled trial. J Int Soc Sports Nutr. 2018 Jan 23;15:5. doi: 10.1186/s12970-018-0208-0. eCollection 2018.
PubMed 29410606
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Recoverben® on Recovery After Exhaustive Exercise in Healthy People - a Randomized, Double-blind, Placebo-controlled Study With Parallel Design
- ClinicalTrials.gov ID
- NCT02923102
- Acronym / sponsor ID
- BTS822/14
- Conditions
- Healthy Volunteers, Muscle Fatigue, Muscle Soreness
- Keywords
- Recovery, Muscle soreness, Lemon Verbena
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Vital Solutions GmbHIndustry (pharma, biotech, devices)
- Study start
- Oct 2016
- Primary completion
- 15 Jan 2017 (actual)
- Study completion
- 15 Mar 2017 (actual)
- First posted
- 4 Oct 2016 (estimated)
- 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.
The aim of the study is to investigate a pre and post workout supplementation (15 days) with Recoverben® , a Aloysia citriodora extract on recovery after exhaustive exercise. Effects will be investigated with 400mg Recoverben® and compared to placebo.
Detailed description
The aim of the study is to investigate a pre and post workout supplementation (15 days) with Recoverben® , a Aloysia citriodora extract on recovery after exhaustive exercise. Effects will be investigated with 400mg Recoverben® and compared to placebo.
Targeted parameter will be determined at the beginning of the study and after supplementation, each. Parameter include maximal strength (MVC), muscle soreness (VAS), pain sensitivity (Algometry) and biomarkers (CK, IL-6, glutathione peroxidase).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aloysia citriodora extract | Active comparator | Dietary Supplement: Aloysia citriodora extractDietary Supplement: Aloysia citriodora extract |
| Placebo Formulation | Placebo comparator | Dietary Supplement: MaltodextrinDietary Supplement: Maltodextrin (no active ingredient) |
Who may qualify
- Ages
- 22 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Subject is able and willing to sign the Informed Consent Form prior to screening evaluations
- Health volunteers: Subject is in good physical and mental health as established by medical his-tory, physical examination, electrocardiogram, vital signs, results of biochemistry and haematology
- Men and women
- Age ≥ 22 and ≤ 50 years
- BMI: 19-30 kg/m2
Key exclusion criteria (14 listed)
- Relevant history, presence of any medical disorder or chronic intake of medication/dietary supplements (e.g. polyphenols, anti-inflammatory or anti-oxidative drugs or supplements, antihyper-tensive drugs) potentially interfering with this study at screening.
- For this study clinically relevant abnormal laboratory, vital signs or physical findings at screening
- Diabetes or serious cardiovascular diseases
- Change of dietary habits within the 2 weeks prior to screening (for instance start of a diet high in vegetables and fruits (≥ 5 portions per day))
- Diet high in vegetables and fruits ≥ 5 portions per day
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 |
|---|---|---|
| Aloysia citriodora extractAlso: Recoverben®2 capsules with 200mg - daily dosage 400mg | Dietary supplement | Aloysia citriodora extract |
| MaltodextrinAlso: Placebo2 capsules with 200mg - daily dosage 400mg | Dietary supplement | Placebo Formulation |
Primary outcome
Change of muscle soreness (VAS) over time
Time frame: Chance over time after 10 days of supplementation (pre stress test and 3h, 24h, 48 h, 96h after stress test)
In the current study, pain following eccentric exercise will be assessed by using a 100 mm visual analogue scale after the subjects performing a standardized movement.
7 secondary outcomes
Monitoring of related adverse events
Time frame: During study execution over 15 days
Change of maximal concentric strength/ maximal voluntary contraction (MVC) over time
Time frame: Chance over time after 10 days of supplementation (pre stress test and 3h, 24h and 48 h after stress test)
Change of pressure pain (Algometry) over time
Time frame: Chance over time after 10 days of supplementation (pre stress test and 3h, 24h and 48 h after stress test)
Change of retrospective pain (Likert scale) over time
Time frame: Chance over time after 10 days of supplementation (pre stress test and 24h, 48h, 96h after stress test)
Change of creatine kinase over time
Time frame: Chance over time after 10 days of supplementation (pre stress test and 3h, 24h and 48 h after stress test)
Change of of glutathione peroxidase over time
Time frame: Chance over time after 10 days of supplementation (pre stress test and 24h and 48 h after stress test)
Change of interleukin-6 over time
Time frame: Chance over time after 10 days of supplementation (pre stress test and 3h, 24h and 48 h after stress test)
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 6 Nov 2017.
- Derived from this study: PubMed 29410606Buchwald-Werner S, Naka I, Wilhelm M, Schutz E, Schoen C, Reule C. Effects of lemon verbena extract (Recoverben(R)) supplementation on muscle strength and recovery after exhaustive exercise: a randomized, placebo-controlled trial. J Int Soc Sports Nutr. 2018 Jan 23;15:5. doi: 10.1186/s12970-018-0208-0. eCollection 2018.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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.
Claudia Reule, Dr. study chair
BioTeSys GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aloysia citriodora extract and Maltodextrin in people with Healthy Volunteers and Muscle Fatigue, run by Vital Solutions GmbH at 1 site in Germany.
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 8 inclusion and 14 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 6 Nov 2017. 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 Germany. 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. Some participants in this study may receive a placebo. 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 of muscle soreness (VAS) over time (time frame: Chance over time after 10 days of supplementation (pre stress test and 3h, 24h, 48 h, 96h after stress test)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02923102, which also lists 1 linked publication.
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 6 Nov 2017.