Effects of Recoverben® on Recovery After Exhaustive Exercise

NCT ID: NCT02923102

Last Updated: 2017-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-03-15

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).

Conditions

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Healthy Volunteers Muscle Fatigue Muscle Soreness

Keywords

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Recovery Muscle soreness Lemon Verbena

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Aloysia citriodora extract

Dietary Supplement: Aloysia citriodora extract

Group Type ACTIVE_COMPARATOR

Aloysia citriodora extract

Intervention Type DIETARY_SUPPLEMENT

2 capsules with 200mg - daily dosage 400mg

Placebo Formulation

Dietary Supplement: Maltodextrin (no active ingredient)

Group Type PLACEBO_COMPARATOR

Maltodextrin

Intervention Type DIETARY_SUPPLEMENT

2 capsules with 200mg - daily dosage 400mg

Interventions

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Aloysia citriodora extract

2 capsules with 200mg - daily dosage 400mg

Intervention Type DIETARY_SUPPLEMENT

Maltodextrin

2 capsules with 200mg - daily dosage 400mg

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Recoverben® Placebo

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
Minimum Eligible Age

22 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vital Solutions GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Claudia Reule, Dr.

Role: STUDY_CHAIR

BioTeSys GmbH

Locations

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Biotesys GmbH

Esslingen am Neckar, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 29410606 (View on PubMed)

Other Identifiers

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BTS822/14

Identifier Type: -

Identifier Source: org_study_id