Effects of Recoverben® on Recovery After Exhaustive Exercise

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers; Muscle Soreness; Muscle Fatigue
• Intervention / Treatment: Dietary supplement: Aloysia citriodora extract; Dietary supplement: Maltodextrin

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Esslingen, Germany, 73728
    • BioTeSys GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Aloysia citriodora extract; Dietary Supplement: Aloysia citriodora extract	Dietary supplement: Aloysia citriodora extract; 2 capsules with 200mg - daily dosage 400mg; Other Names: Recoverben®
PLACEBO_COMPARATOR: Placebo Formulation; Dietary Supplement: Maltodextrin (no active ingredient)	Dietary supplement: Maltodextrin; 2 capsules with 200mg - daily dosage 400mg; Other Names: Placebo

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Vital Solutions GmbH
• Investigators: Study Chair: Claudia Reule, Dr., BioTeSys GmbH

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (ACTUAL): January 15, 2017
• Study Completion (ACTUAL): March 15, 2017

Study Registration Dates

• First Submitted: September 28, 2016
• First Submitted That Met QC Criteria: September 30, 2016
• First Posted (ESTIMATE): October 4, 2016

Study Record Updates

• Last Update Posted (ACTUAL): November 6, 2017
• Last Update Submitted That Met QC Criteria: November 1, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Recovery; Muscle soreness; Lemon Verbena
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Musculoskeletal Pain; Myalgia
• Other Study ID Numbers: BTS822/14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO