Protein Supplements to Cyclists

Not Applicable

• Conditions: Reconstitution After Bicycle Intervention
• Interventions: Dietary Supplement: Active protein drink

• Registration Number: NCT03136133
• Lead Sponsor: Haukeland University Hospital

Brief Summary

To investigate the effect of marine peptide combined with dietary protein on the capacity to recover after exhaustive endurance cycling as measured by exercise capacity and blood glucose homeostasis.

Detailed Description

The current study uses cyclists as test subjects since they represent a physical demanding sport requiring both high endurance capacity and muscle strength. In the recovery phase following exhaustive physical activity there is a need both for rebuilding the muscle energy stores, for muscle repair and for compensatory muscle cell development. Therefore, marine peptide combined with dietary protein will be given in order to examine the capacity to recover after exhaustive endurance cycling.

Study Timeline

• Study First Submitted: 2017-04-27
• Study First Submitted QC: 2017-04-27
• Study First Posted: 2017-05-02
• Status Verified: 2017-09
• Study Start: 2017-09-14
• Last Update Submitted: 2017-09-14
• Last Update Posted: 2017-09-15
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 16

Inclusion Criteria

• Signed informed Consent
• The subject is a man between 40-50 years
• The subject has a body mass index (BMI) between 19-29
• Willing to comply with all study procedures and be available for the length of the study
• In good general health as judged by the physician at the screening visit

Exclusion Criteria

• The subject has had surgery or trauma with significant blood loss or has donated blood within the last 3 months prior to the screening visit
• Diabetes type 1 or 2, or persistent high blood sugar levels
• The subject has tested positive for human immunodeficiency virus (HIV)
• Hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (anti-HCV)
• The subject has taken any investigational drugs within 1 month prior to screening
• Treated with antibiotics within 3 months prior to screening (oral, parenteral or rectal), but not spray or ointment
• Treated with steroids within 1 month prior to screening (including oral treatment)
• Treated with medication that effects the intestinal function such as, H2- protonpump inhibitors, diuretics, antiemetics, antidepressants, antacids,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo drink	Active protein drink	Placebo drink
Active protein drink	Active protein drink	Active protein drink

Primary Outcome Measures

Name	Time	Method
Change in blood glucose compared to placebo	Change from baseline to every 30 minutes after dosing, for 2 hours

Secondary Outcome Measures

Name	Time	Method
Change in insulin-like peptide 5 compared to placebo	Change from baseline to every 30 minutes after dosing, for 2 hours

Trial Locations

Locations (1)

Haukeland University Hospital; 🇳🇴 Bergen, Norway