Protein Supplements to Cyclists

Effekt of Marine Peptide Supplementation on Recovery Following Endurance Cycling

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.

Study Overview

• Status: Unknown
• Conditions: Reconstitution After Bicycle Intervention
• Intervention / Treatment: Dietary supplement: Active protein drink

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 Type: Interventional
• Enrollment (Anticipated): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Bergen, Norway, 5021
    • Recruiting
    • Haukeland University Hospital
    • Contact: Trygve Hausken, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Dietary supplement: Active protein drink; Fish protein from cod to be used for man after Heavy excercise to restitute

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Collaborators: Firmenich Bjørge Biomarine As

Publications and helpful links

General Publications

• Mjos I, Thorsen E, Hausken T, Lied E, Nilsen RM, Bronstad I, Edvardsen E, Frisk B. The effect of low dose marine protein hydrolysates on short-term recovery after high intensity performance cycling: a double-blinded crossover study. J Int Soc Sports Nutr. 2019 Oct 29;16(1):48. doi: 10.1186/s12970-019-0318-3. Erratum In: J Int Soc Sports Nutr. 2020 Jan 3;17(1):1.

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2017
• Primary Completion (Anticipated): December 31, 2018
• Study Completion (Anticipated): December 31, 2018

Study Registration Dates

• First Submitted: April 27, 2017
• First Submitted That Met QC Criteria: April 27, 2017
• First Posted (Actual): May 2, 2017

Study Record Updates

• Last Update Posted (Actual): September 15, 2017
• Last Update Submitted That Met QC Criteria: September 14, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 2017/56

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No