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Effects of Recoverben® on Recovery After Exhaustive Exercise

Primary Purpose

Healthy Volunteers, Muscle Fatigue, Muscle Soreness

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Aloysia citriodora extract

Maltodextrin

About this trial

This is an interventional prevention trial for Healthy Volunteers focused on measuring Recovery, Muscle soreness, Lemon Verbena

Eligibility Criteria

22 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Biotesys GmbH

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Aloysia citriodora extract

Placebo Formulation

Arm Description

Dietary Supplement: Aloysia citriodora extract

Dietary Supplement: Maltodextrin (no active ingredient)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Monitoring of related adverse events

Reporting of adverse effects to evaluate tolerability

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

Change of pressure pain (Algometry) over time

The threshold for pressure induced pain will be measured using an algometer.

Change of retrospective pain (Likert scale) over time

Evaluation of the perceived pain retrospectively by using the Likert scale for muscle soreness

Change of creatine kinase over time

Change of of glutathione peroxidase over time

Change of interleukin-6 over time

Full Information

NCT ID

NCT02923102

First Posted

September 28, 2016

Last Updated

November 1, 2017

Sponsor

Vital Solutions GmbH

1. Study Identification

Unique Protocol Identification Number

NCT02923102

Brief Title

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

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

October 2016 (undefined)

Primary Completion Date

January 15, 2017 (Actual)

Study Completion Date

March 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Vital Solutions GmbH

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy Volunteers, Muscle Fatigue, Muscle Soreness

Keywords

Recovery, Muscle soreness, Lemon Verbena

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Aloysia citriodora extract

Arm Type

Active Comparator

Arm Description

Dietary Supplement: Aloysia citriodora extract

Arm Title

Placebo Formulation

Arm Type

Placebo Comparator

Arm Description

Dietary Supplement: Maltodextrin (no active ingredient)

Intervention Type

Dietary Supplement

Intervention Name(s)

Aloysia citriodora extract

Other Intervention Name(s)

Recoverben®

Intervention Description

2 capsules with 200mg - daily dosage 400mg

Intervention Type

Dietary Supplement

Intervention Name(s)

Maltodextrin

Other Intervention Name(s)

Placebo

Intervention Description

2 capsules with 200mg - daily dosage 400mg

Primary Outcome Measure Information:

Title

Change of muscle soreness (VAS) over time

Description

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.

Time Frame

Chance over time after 10 days of supplementation (pre stress test and 3h, 24h, 48 h, 96h after stress test)

Secondary Outcome Measure Information:

Title

Monitoring of related adverse events

Description

Reporting of adverse effects to evaluate tolerability

Time Frame

During study execution over 15 days

Title

Change of maximal concentric strength/ maximal voluntary contraction (MVC) over time

Description

Maximal concentric strength of the M. Quadriceps femoris will be assessed by measuring maximal isometric concentric strength using a dynamometer

Time Frame

Chance over time after 10 days of supplementation (pre stress test and 3h, 24h and 48 h after stress test)

Title

Change of pressure pain (Algometry) over time

Description

The threshold for pressure induced pain will be measured using an algometer.

Time Frame

Chance over time after 10 days of supplementation (pre stress test and 3h, 24h and 48 h after stress test)

Title

Change of retrospective pain (Likert scale) over time

Description

Evaluation of the perceived pain retrospectively by using the Likert scale for muscle soreness

Time Frame

Chance over time after 10 days of supplementation (pre stress test and 24h, 48h, 96h after stress test)

Title

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)

Title

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)

Title

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

22 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Claudia Reule, Dr.

Organizational Affiliation

BioTeSys GmbH

Official's Role

Study Chair

Facility Information:

Facility Name

Biotesys GmbH

City

Esslingen

ZIP/Postal Code

73728

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

29410606

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.

Results Reference

derived

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Effects of Recoverben® on Recovery After Exhaustive Exercise

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