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Effects of Recoverben® on Recovery After Exhaustive Exercise

V

Vital Solutions Swiss

Status

Completed

Conditions

Healthy Volunteers
Muscle Soreness
Muscle Fatigue

Treatments

Dietary Supplement: Aloysia citriodora extract
Dietary Supplement: Maltodextrin

Study type

Interventional

Funder types

Industry

Identifiers

NCT02923102
BTS822/14

Details and patient eligibility

About

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.

Full 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).

Enrollment

40 patients

Sex

All

Ages

22 to 50 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

40 participants in 2 patient groups, including a placebo group

Aloysia citriodora extract
Active Comparator group
Description:
Dietary Supplement: Aloysia citriodora extract
Treatment:
Dietary Supplement: Aloysia citriodora extract
Placebo Formulation
Placebo Comparator group
Description:
Dietary Supplement: Maltodextrin (no active ingredient)
Treatment:
Dietary Supplement: Maltodextrin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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