Protein Supplements to Cyclists

Study Overview
=================
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.

Official Title
-----------------
Effekt of Marine Peptide Supplementation on Recovery Following Endurance Cycling

Conditions
-----------------
Reconstitution After Bicycle Intervention

Intervention / Treatment
-----------------
* Dietary Supplement: Active protein drink


Participation Criteria
=================
Eligibility Criteria
-----------------
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,

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Crossover, placebo controlled
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active protein drink<br>Active protein drink | Dietary Supplement: Active protein drink<br>* Fish protein from cod to be used for man after Heavy excercise to restitute<br>|
| Placebo Comparator: Placebo drink<br>Placebo drink | Dietary Supplement: Active protein drink<br>* Fish protein from cod to be used for man after Heavy excercise to restitute<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood glucose compared to placebo |  | Change from baseline to every 30 minutes after dosing, for 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in insulin-like peptide 5 compared to placebo |  | Change from baseline to every 30 minutes after dosing, for 2 hours |