Effects of Recoverben® on Recovery After Exhaustive Exercise

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02923102
• Other study ID #: BTS822/14
• Status: Completed
• Phase: N/A
• First received: September 28, 2016
• Last updated: November 1, 2017
• Start date: October 2016
• Est. completion date: March 15, 2017

Study information

• Verified date: November 2017
• Source: Vital Solutions GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 15, 2017
• Est. primary completion date: January 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Healthy Volunteers
• Muscle Fatigue
• Muscle Soreness
• Myalgia

Intervention

Dietary Supplement:
• Aloysia citriodora extract
2 capsules with 200mg - daily dosage 400mg
• Maltodextrin
2 capsules with 200mg - daily dosage 400mg

Locations

Country	Name	City	State
Germany	Biotesys GmbH	Esslingen

Sponsors (1)

Lead Sponsor	Collaborator
Vital Solutions GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Monitoring of related adverse events	Reporting of adverse effects to evaluate tolerability	During study execution over 15 days
Secondary	Change of maximal concentric strength/ maximal voluntary contraction (MVC) over time	Maximal concentric strength of the M. Quadriceps femoris will be assessed by measuring maximal isometric concentric strength using a dynamometer	Chance over time after 10 days of supplementation (pre stress test and 3h, 24h and 48 h after stress test)
Secondary	Change of pressure pain (Algometry) over time	The threshold for pressure induced pain will be measured using an algometer.	Chance over time after 10 days of supplementation (pre stress test and 3h, 24h and 48 h after stress test)
Secondary	Change of retrospective pain (Likert scale) over time	Evaluation of the perceived pain retrospectively by using the Likert scale for muscle soreness	Chance over time after 10 days of supplementation (pre stress test and 24h, 48h, 96h after stress test)
Secondary	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)
Secondary	Change of of glutathione peroxidase over time		Chance over time after 10 days of supplementation (pre stress test and 24h and 48 h after stress test)
Secondary	Change of interleukin-6 over time		Chance over time after 10 days of supplementation (pre stress test and 3h, 24h and 48 h after stress test)