- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05149079
Effects of a Marine Protein Hydrolysate in Healthy Adults (MARPEP)
Randomized, Double Blind, Placebo Controlled Clinical Study to Investigate the Effect of a Marine Protein Hydrolysate in Healthy Adults
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Marine protein sources, including fish and fish protein hydrolysates, may have particular health benefits. Health benefits from fish consumption have been attributed to the n-3 polyunsaturated fatty acids, in particular eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). Proteins from marine sources may contain valuable bioactive components, with amino acid composition and protein profiles that differ from terrestrial sources. Generally, the dietary source of protein can affect cellular energy metabolism, and hydrolyzed peptides can have potent and specific bioactive potential.
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bergen, Norway, 5009
- Research Unit for Health Trials
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy female and male subjects at age 20-80 years old understanding Norwegian oral and written information
- Waist circumference for males < 102 cm and females < 88 cm
Exclusion Criteria:
- Pregnancy or lactation
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo (whey protein supplement)
Participants will consume 18 g of the placebo whey protein supplement each day for 12 weeks.
|
Whey protein powder, commercially available
Other Names:
|
Active Comparator: Cod protein hydrolysate supplement
Participants will consume 18 g of the cod protein supplement each day for 12 weeks.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in the cardiovascular index (triacylglycerol/high density lipoprotein (HDL)-cholesterol × waist/hip ratio)
Time Frame: Baseline to 12 weeks
|
Triacylclygerol and HDL-cholesterol concentrations will be measured in serum.
Waist and hip circumference will be measured using anthropometric tape over light clothing.
For waist circumference, the minimum circumference between the iliac crest and the rib cage will be used.
For waist circumference the circumference at the level of the greatest protrusion of the buttocks is used.
|
Baseline to 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in the Quick1 index, a surrogate marker of insulin sensitivity
Time Frame: Baseline to 12 weeks
|
Measured in serum and calculated as 1 / (log(fasting insulin μU/mL) + log(fasting glucose mg/dL)
|
Baseline to 12 weeks
|
Changes in fasting insulin
Time Frame: Baseline to 12 weeks
|
Measured in serum
|
Baseline to 12 weeks
|
Changes in fasting insulin C-peptide
Time Frame: Baseline to 12 weeks
|
Measured in serum
|
Baseline to 12 weeks
|
Changes in fasting glucose
Time Frame: Baseline to 12 weeks
|
Measured in serum
|
Baseline to 12 weeks
|
Changes in total cholesterol
Time Frame: Baseline to 12 weeks
|
Measured in serum
|
Baseline to 12 weeks
|
Changes in non-high density lipoprotein (HDL) cholesterol
Time Frame: Baseline to 12 weeks
|
Measured in serum
|
Baseline to 12 weeks
|
Changes in non-esterified fatty acids (NEFA)
Time Frame: Baseline to 12 weeks
|
Measured in serum
|
Baseline to 12 weeks
|
Changes in triacylglycerol (TAG)
Time Frame: Baseline to 12 weeks
|
Measured in serum
|
Baseline to 12 weeks
|
Changes in gut microbiota composition
Time Frame: Baseline to 12 weeks
|
Measured by 16S sequencing
|
Baseline to 12 weeks
|
Changes in short chained fatty acids (SCFA)
Time Frame: Baseline to 12 weeks
|
Faecal SCFA concentrations calculated as (mmol/L) × wet faecal weight x faecal moisture content (g/100 g) × 10
|
Baseline to 12 weeks
|
Changes in fat mass/fat free mass ratio
Time Frame: Baseline to 12 weeks
|
Body composition measured by bioimpedance analysis
|
Baseline to 12 weeks
|
Changes in waist-hip ratio
Time Frame: Baseline to 12 weeks
|
Waist and hip circumference will be measured using anthropometric tape over light clothing.
For waist circumference, the minimum circumference between the iliac crest and the rib cage will be used.
For waist circumference the circumference at the level of the greatest protrusion of the buttocks is used
|
Baseline to 12 weeks
|
Changes in waist-to-height ratio (WHtR)
Time Frame: Baseline to 12 weeks
|
Waist circumference will be measured using anthropometric tape over light clothing.
Hight will be measured using a stadiometer.
For waist circumference, the minimum circumference between the iliac crest and the rib cage will be used.
|
Baseline to 12 weeks
|
Changes in blood pressure
Time Frame: Baseline to 12 weeks
|
Blood pressure measurement will be performed manually by a trained nurse using standard equipment
|
Baseline to 12 weeks
|
Changes in heart rate
Time Frame: Baseline to 12 weeks
|
Heart rate will be determined manually by a trained nurse
|
Baseline to 12 weeks
|
Changes in glucagon-like peptide 1 (GLP-1, hormone involved in appetite and metabolism regulation)
Time Frame: Baseline to 12 weeks
|
Measured in plasma by ELISA (enzyme-linked immunosorbent assay)
|
Baseline to 12 weeks
|
Changes in gastric inhibitory polypeptide (GIP, hormone involved in metabolism regulation)
Time Frame: Baseline to 12 weeks
|
Measured in plasma by ELISA (enzyme-linked immunosorbent assay)
|
Baseline to 12 weeks
|
Changes in ghrelin (hormone involved in appetite regulation)
Time Frame: Baseline to 12 weeks
|
Measured in plasma by ELISA (enzyme-linked immunosorbent assay)
|
Baseline to 12 weeks
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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. Review.
- Erdmann K, Cheung BW, Schröder 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. Review.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- FHF-Study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy Diet
-
University of ReadingActive, not recruitingDiet Modification | Diet, Healthy | Diet HabitUnited Kingdom
-
Instituto Nacional de Ciencias Medicas y Nutricion...Active, not recruitingDiet, Healthy | Diet Habit | Nutrition, Healthy | Dietary ExposureMexico
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
-
Washington State UniversityUnited States Department of Agriculture (USDA)Not yet recruitingHealth Behavior | Diet, Healthy | Diet HabitUnited States
-
Lund UniversityCompletedHealthy Subjects | Diet, HealthySweden
-
Luis María Béjar PradoRecruitingHealthy Eating Index | Mediterranean Diet | Diet HabitsSpain
-
University of HawaiiPennington Biomedical Research Center; United States Department of Agriculture...RecruitingDiet, HealthyUnited States
-
Harokopio UniversityRecruiting
-
Universitas Katolik Widya Mandala SurabayaNot yet recruitingDiet, HealthyIndonesia
-
Ohio State University Comprehensive Cancer CenterRecruitingHealthy DietUnited States
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States