Protein Supplements to Cyclists

Reconstitution After Bicycle Intervention Clinical Trial

Official title:

Effekt of Marine Peptide Supplementation on Recovery Following Endurance Cycling

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03136133
• Other study ID #: 2017/56
• Status: Recruiting
• Phase: N/A
• First received: April 27, 2017
• Last updated: September 14, 2017
• Start date: September 14, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: September 2017
• Source: Haukeland University Hospital
• Contact: Trygve Hausken, MD
• Phone: +4755972134
• Email: trygve.hausken[@]helse-bergen.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 50 Years

Eligibility

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,

Related Conditions & MeSH terms

• Reconstitution After Bicycle Intervention

Intervention

Dietary Supplement:
• Active protein drink
Fish protein from cod to be used for man after Heavy excercise to restitute

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen

Sponsors (2)

Lead Sponsor	Collaborator
Haukeland University Hospital	Firmenich Bjørge Biomarine As

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in blood glucose compared to placebo		Change from baseline to every 30 minutes after dosing, for 2 hours
Secondary	Change in insulin-like peptide 5 compared to placebo		Change from baseline to every 30 minutes after dosing, for 2 hours