Effects of Recoverben® on Recovery After Exhaustive Exercise

Study Overview
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Brief Summary
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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
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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).

Official Title
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Effects of Recoverben® on Recovery After Exhaustive Exercise in Healthy People - a Randomized, Double-blind, Placebo-controlled Study With Parallel Design

Conditions
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Healthy Volunteers, Muscle Fatigue, Muscle Soreness

Intervention / Treatment
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* Dietary Supplement: Aloysia citriodora extract
* Dietary Supplement: Maltodextrin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Aloysia citriodora extract<br>Dietary Supplement: Aloysia citriodora extract | Dietary Supplement: Aloysia citriodora extract<br>* 2 capsules with 200mg - daily dosage 400mg<br>* Other names: Recoverben®;|
| Placebo Comparator: Placebo Formulation<br>Dietary Supplement: Maltodextrin (no active ingredient) | Dietary Supplement: Maltodextrin<br>* 2 capsules with 200mg - daily dosage 400mg<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Chance over time after 10 days of supplementation (pre stress test and 3h, 24h, 48 h, 96h after stress test) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monitoring of related adverse events | Reporting of adverse effects to evaluate tolerability | 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 | 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. | 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 | Chance over time after 10 days of supplementation (pre stress test and 24h, 48h, 96h after stress test) | 
| Change of creatine kinase over time |  | 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 |  | 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 |  | Chance over time after 10 days of supplementation (pre stress test and 3h, 24h and 48 h after stress test) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Recovery, Muscle soreness, Lemon Verbena