Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    marine peptides
Previous Study | Return to List | Next Study

Protein Supplements to Cyclists

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03136133
Recruitment Status : Unknown
Verified September 2017 by Haukeland University Hospital.
Recruitment status was:  Recruiting
First Posted : May 2, 2017
Last Update Posted : September 15, 2017
Sponsor:
Collaborator:
Firmenich Bjørge Biomarine As
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Reconstitution After Bicycle Intervention Dietary Supplement: Active protein drink Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Crossover, placebo controlled
Masking: Single (Participant)
Masking Description: Protein drink With matching placebo
Primary Purpose: Treatment
Official Title: Effekt of Marine Peptide Supplementation on Recovery Following Endurance Cycling
Actual Study Start Date : September 14, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Arm Intervention/treatment
Active Comparator: Active protein drink
Active protein drink
Dietary Supplement: Active protein drink
Fish protein from cod to be used for man after Heavy excercise to restitute

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




Primary Outcome Measures :
  1. Change in blood glucose compared to placebo [ Time Frame: Change from baseline to every 30 minutes after dosing, for 2 hours ]

Secondary Outcome Measures :
  1. Change in insulin-like peptide 5 compared to placebo [ Time Frame: Change from baseline to every 30 minutes after dosing, for 2 hours ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03136133


Contacts
Layout table for location contacts
Contact: Trygve Hausken, MD +4755972134 trygve.hausken@helse-bergen.no
Contact: Bente Frisk +4755970440 bente.frisk@helse-bergen.no

Locations
Layout table for location information
Norway
Haukeland University Hospital Recruiting
Bergen, Norway, 5021
Contact: Trygve Hausken, MD         
Sponsors and Collaborators
Haukeland University Hospital
Firmenich Bjørge Biomarine As

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT03136133     History of Changes
Other Study ID Numbers: 2017/56
First Posted: May 2, 2017    Key Record Dates
Last Update Posted: September 15, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No