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Completed

NCT Number: NCT02923102

Effects of Recoverben® on Recovery After Exhaustive Exercise

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.

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Key information

Age range

22 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Biotesys GmbH

Esslingen am Neckar, 73728, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aloysia citriodora extract

Dietary Supplement

2 capsules with 200mg - daily dosage 400mg

Other names: Recoverben®

Maltodextrin

Dietary Supplement

2 capsules with 200mg - daily dosage 400mg

Other names: Placebo

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Vital Solutions GmbH

Industry

Registry information

Official study title

Effects of Recoverben® on Recovery After Exhaustive Exercise in Healthy People - a Randomized, Double-blind, Placebo-controlled Study With Parallel Design

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 4, 2016
Registry last updated
Nov 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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