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Effects of Recoverben® on Recovery After Exhaustive Exercise

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ClinicalTrials.gov Identifier: NCT02923102
Recruitment Status : Completed
First Posted : October 4, 2016
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Vital Solutions GmbH

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Muscle Fatigue Muscle Soreness Dietary Supplement: Aloysia citriodora extract Dietary Supplement: Maltodextrin Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Recoverben® on Recovery After Exhaustive Exercise in Healthy People - a Randomized, Double-blind, Placebo-controlled Study With Parallel Design
Study Start Date : October 2016
Actual Primary Completion Date : January 15, 2017
Actual Study Completion Date : March 15, 2017

Resource links provided by the National Library of Medicine


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 Name: Recoverben®

Placebo Comparator: Placebo Formulation
Dietary Supplement: Maltodextrin (no active ingredient)
Dietary Supplement: Maltodextrin
2 capsules with 200mg - daily dosage 400mg
Other Name: Placebo




Primary Outcome Measures :
  1. Change of muscle soreness (VAS) over time [ Time Frame: Chance over time after 10 days of supplementation (pre stress test and 3h, 24h, 48 h, 96h after stress test) ]
    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 :
  1. Monitoring of related adverse events [ Time Frame: During study execution over 15 days ]
    Reporting of adverse effects to evaluate tolerability

  2. Change of maximal concentric strength/ maximal voluntary contraction (MVC) over time [ Time Frame: Chance over time after 10 days of supplementation (pre stress test and 3h, 24h and 48 h after stress test) ]
    Maximal concentric strength of the M. Quadriceps femoris will be assessed by measuring maximal isometric concentric strength using a dynamometer

  3. Change of pressure pain (Algometry) over time [ Time Frame: Chance over time after 10 days of supplementation (pre stress test and 3h, 24h and 48 h after stress test) ]
    The threshold for pressure induced pain will be measured using an algometer.

  4. Change of retrospective pain (Likert scale) over time [ Time Frame: Chance over time after 10 days of supplementation (pre stress test and 24h, 48h, 96h after stress test) ]
    Evaluation of the perceived pain retrospectively by using the Likert scale for muscle soreness

  5. 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) ]
  6. 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) ]
  7. 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) ]


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Ages Eligible for Study:   22 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02923102


Locations
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Germany
Biotesys GmbH
Esslingen, Germany, 73728
Sponsors and Collaborators
Vital Solutions GmbH
Investigators
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Study Chair: Claudia Reule, Dr. BioTeSys GmbH

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Vital Solutions GmbH
ClinicalTrials.gov Identifier: NCT02923102     History of Changes
Other Study ID Numbers: BTS822/14
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Vital Solutions GmbH:
Recovery
Muscle soreness
Lemon Verbena
Additional relevant MeSH terms:
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Myalgia
Fatigue
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Musculoskeletal Pain
Pain
Neurologic Manifestations