Effects of a Marine Protein Hydrolysate in Healthy Adults
NCT ID: NCT05149079
Last Updated: 2021-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
67 participants
INTERVENTIONAL
2021-02-01
2021-05-31
Brief Summary
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Detailed Description
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Rest raw materials (RRM) from cod (Fjordlaks AS, Norway) are used for the hydrolysis production (Food Grade). Freshly minced RRM were treated with enzymes optimized to generate bioactive hydrolysates using facilities and techniques approved for human consumption. The investigational products are given in a dose of 18 g protein per day, corresponding to the protein content of a standard meal, and similar to doses recommended in a range of protein supplements.
The study enrolls around 70 men and women age of 20-80 years with waist circumference of \< 102 cm for men and \< 88 cm for women. Prospective study participants were informed of the study and invited to participate through advertising primarily in social media (Facebook advertisement, geographically limited to 12 km surrounding the city centers of Bergen and Ålesund). Participants provided written informed consent, and were screened via self-reporting in an online form in EasyTrial hosted by the Research Unit for Clinical Trials at the University of Bergen. Data collection by the study staff at baseline verifies inclusion and exclusion criteria and participant eligibility prior to randomization. The potential participants are informed about practical details at a digital or physical meeting 1-2 weeks prior to baseline.
Groups of participants (40-60% males/females) are block randomized to the two treatments using randomly selected block sizes, and stratified according to sex.
The participants are given a container with the powder sufficient for the entire study period, and a spoon to measure the intake at breakfast (6 g), lunch (6 g) and supper (6 g), or morning (9 g) and evening (9 g) according to individual preference. The patients will mix the powder products in water or mineral water. Flavours have been masked by supplementation with beet powder, and mixing 0.5 g fish hydrolysate per serving in the placebo, to minimize differences in taste of the placebo and active product.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo (whey protein supplement)
Participants will consume 18 g of the placebo whey protein supplement each day for 12 weeks.
Placebo
Whey protein powder, commercially available
Cod protein hydrolysate supplement
Participants will consume 18 g of the cod protein supplement each day for 12 weeks.
Cod protein hydrolysate
Rest raw materials (RRM) from cod (Fjordlaks AS, Norway) are used for the hydrolysis production (Food Grade). Freshly minced RRM is treated wth enzymes optimized to generate bioactive hydrolysates using facilities and techniques approved for human consumption.
Interventions
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Cod protein hydrolysate
Rest raw materials (RRM) from cod (Fjordlaks AS, Norway) are used for the hydrolysis production (Food Grade). Freshly minced RRM is treated wth enzymes optimized to generate bioactive hydrolysates using facilities and techniques approved for human consumption.
Placebo
Whey protein powder, commercially available
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Waist circumference for males \< 102 cm and females \< 88 cm
Exclusion Criteria
* Having used high-dose omega-3 PUFA supplements (\>2 g/day) less than 28 days prior to randomization
* Use of corticosteroids that will influence protein metabolism
* Antibiotic treatment previous 3 months
* Alcohol or drug abuse or any conditions associated with poor compliance
* Medical diagnosis of malabsorption disorders, Crohn's disease, or lactose intolerance
* Scheduled hospitalization during the course of the study that could compromise the study
* Diabetes type I or II, serious high blood pressure at screening, serious infections, diseases requiring medication that can influence the study
* Known or suspected sensitivity or allergic reactions to the IMP or excipients
* Presence of other major medical or psychiatric illness that would affect the ability to participate in the study or put the subject at increased risk
* Intake of statins. If needed to obtain the recruitment goals, we will accept people using a low dose of statin
20 Years
80 Years
ALL
Yes
Sponsors
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Haukeland University Hospital
OTHER
Alesund Hospital
OTHER
Norwegian University of Science and Technology
OTHER
University of Bergen
OTHER
Responsible Party
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Principal Investigators
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Rolf K Berge, PhD
Role: STUDY_DIRECTOR
University of Bergen, Norway
Locations
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Research Unit for Health Trials
Bergen, , Norway
Countries
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References
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Kim SK, Ngo DH, Vo TS. Marine fish-derived bioactive peptides as potential antihypertensive agents. Adv Food Nutr Res. 2012;65:249-60. doi: 10.1016/B978-0-12-416003-3.00016-0.
Erdmann K, Cheung BW, Schroder H. The possible roles of food-derived bioactive peptides in reducing the risk of cardiovascular disease. J Nutr Biochem. 2008 Oct;19(10):643-54. doi: 10.1016/j.jnutbio.2007.11.010. Epub 2008 May 20.
Other Identifiers
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FHF-Study
Identifier Type: -
Identifier Source: org_study_id