Effects of Recoverben® on Recovery After Exhaustive Exercise

NCT02923102 | Completed

• 1 other identifier: BTS822/14
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers; Muscle Fatigue; Muscle Soreness

Keywords

Recovery; Muscle soreness; Lemon Verbena

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Monitoring of related adverse events

  During study execution over 15 days

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

  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

  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

  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)

Study Arms (2)

Aloysia citriodora extract

ACTIVE COMPARATOR

Dietary Supplement: Aloysia citriodora extract

Dietary Supplement: Aloysia citriodora extract

Placebo Formulation

PLACEBO COMPARATOR

Dietary Supplement: Maltodextrin (no active ingredient)

Dietary Supplement: Maltodextrin

Interventions

Aloysia citriodora extract DIETARY_SUPPLEMENT

2 capsules with 200mg - daily dosage 400mg

Also known as: Recoverben®

Aloysia citriodora extract

Maltodextrin DIETARY_SUPPLEMENT

2 capsules with 200mg - daily dosage 400mg

Also known as: Placebo

Placebo Formulation

Eligibility Criteria

• Age: 22 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vital Solutions GmbH: lead

Study Sites (1)

Biotesys GmbH

Esslingen am Neckar, 73728, Germany

Location

Related Publications (1)

• 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.

  PMID: 29410606 DERIVED

MeSH Terms

Conditions

Myalgia

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Claudia Reule, Dr.

  BioTeSys GmbH

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2016
• First Posted: October 4, 2016
• Study Start: October 1, 2016
• Primary Completion: January 15, 2017
• Study Completion: March 15, 2017
• Last Updated: November 6, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)