Clinical trial NCT03136133: Protein Supplements to Cyclists
Official title: Effekt of Marine Peptide Supplementation on Recovery Following Endurance Cycling
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Reconstitution After Bicycle Intervention
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: Firmenich Bjørge Biomarine As
First posted: 2017-05-02
Enrollment: 16
Sex: MALE
Minimum age (years): 40
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover, placebo controlled
Primary purpose: TREATMENT

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.

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,

Primary outcomes:
measure: Change in blood glucose compared to placebo
timeFrame: Change from baseline to every 30 minutes after dosing, for 2 hours
Secondary outcomes:
measure: Change in insulin-like peptide 5 compared to placebo
timeFrame: Change from baseline to every 30 minutes after dosing, for 2 hours
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
Study officials:
References:
citation: 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.