Protein Supplements to Cyclists

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03136133
• Date of registration: 27/04/2017
• Prospective Registration: Yes
• Primary sponsor: Haukeland University Hospital
• Public title: Protein Supplements to Cyclists
• Scientific title: Effekt of Marine Peptide Supplementation on Recovery Following Endurance Cycling
• Date of first enrolment: September 14, 2017
• Target sample size: 16
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03136133
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Single (Participant).
• Phase: N/A

Countries of recruitment

Norway

Contacts

• Name: Trygve Hausken, MD

• Name: Trygve Hausken, MD

Key inclusion & exclusion 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,



Age minimum: 40 Years
Age maximum: 50 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Reconstitution After Bicycle Intervention

Intervention(s)

Dietary Supplement: Active protein drink

Primary Outcome(s)

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

Secondary Outcome(s)

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

Secondary ID(s)

2017/56

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Firmenich Bjørge Biomarine As