Clinical trial NCT02923102: Effects of Recoverben® on Recovery After Exhaustive Exercise
Official title: Effects of Recoverben® on Recovery After Exhaustive Exercise in Healthy People - a Randomized, Double-blind, Placebo-controlled Study With Parallel Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Muscle Fatigue
Muscle Soreness
Keywords: Recovery
Muscle soreness
Lemon Verbena
Lead sponsor: Vital Solutions GmbH
Sponsor class: INDUSTRY
First posted: 2016-10-04
Enrollment: 40
Sex: ALL
Minimum age (years): 22
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.
* 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

Primary outcomes:
measure: Change of muscle soreness (VAS) over time
timeFrame: Chance over time after 10 days of supplementation (pre stress test and 3h, 24h, 48 h, 96h after stress test)
Secondary outcomes:
measure: Monitoring of related adverse events
timeFrame: During study execution over 15 days
measure: Change of maximal concentric strength/ maximal voluntary contraction (MVC) over time
timeFrame: Chance over time after 10 days of supplementation (pre stress test and 3h, 24h and 48 h after stress test)
measure: Change of pressure pain (Algometry) over time
timeFrame: Chance over time after 10 days of supplementation (pre stress test and 3h, 24h and 48 h after stress test)
measure: Change of retrospective pain (Likert scale) over time
timeFrame: Chance over time after 10 days of supplementation (pre stress test and 24h, 48h, 96h after stress test)
measure: Change of creatine kinase over time
timeFrame: Chance over time after 10 days of supplementation (pre stress test and 3h, 24h and 48 h after stress test)
measure: Change of of glutathione peroxidase over time
timeFrame: Chance over time after 10 days of supplementation (pre stress test and 24h and 48 h after stress test)
measure: Change of interleukin-6 over time
timeFrame: Chance over time after 10 days of supplementation (pre stress test and 3h, 24h and 48 h after stress test)
Other outcomes:
Locations:
city: Esslingen
country: Germany
facility: Biotesys GmbH
Study officials:
affiliation: BioTeSys GmbH
name: Claudia Reule, Dr.
role: STUDY_CHAIR
References:
citation: 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.