Healthy DietMARPEPNCT05149079
Effects of a Marine Protein Hydrolysate in Healthy Adults
A study testing Cod protein hydrolysate in people with Healthy Diet, run by University of Bergen at 1 site in Norway.
Trial summary
This randomized, double blind, controlled trial investigates changes in the cardiovascular index (triacylglycerol/HDL-cholesterol × waist/hip ratio) after 12 weeks of marine protein hydrolysate (MPH) or whey protein powder (placebo) supplementation in adult healthy persons. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Diet
- What is being tested?
- Cod protein hydrolysate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 1 siteNorway
- Study dates
- 1 Feb 2021to 31 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double Blind, Placebo Controlled Clinical Study to Investigate the Effect of a Marine Protein Hydrolysate in Healthy Adults
This randomized, double blind, controlled trial investigates changes in the cardiovascular index (triacylglycerol/HDL-cholesterol × waist/hip ratio) after 12 weeks of marine protein hydrolysate (MPH) or whey protein powder (placebo) supplementation in adult healthy persons. Additionally, the study investigates potential effects on plasma parameters of metabolic health including lipids, glucose, inflammatory parameters and redox state, as well as associations between dietary MPH and body weight, abdominal obesity, body composition, and gut microbiota composition. Finally, putative end-products of diet-microbial interactions (TMAO and short-chain fatty acids) with CVD risk factors and biomarkers of mitochondrial function are examined.
Read the 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.
- Conditions
- Healthy Diet
- Being tested
- Cod protein hydrolysate, Placebo
- Keywords
- Cardiovascular disease risk, Protein supplementation, Metabolic health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cod protein hydrolysateDietary supplement
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.
PlaceboDietary supplement
Also called Whey protein powder
Whey protein powder, commercially available
| Study group | Role | What they receive |
|---|---|---|
| Placebo (whey protein supplement) | Placebo comparator | Participants will consume 18 g of the placebo whey protein supplement each day for 12 weeks. Receives: Dietary Supplement: Placebo |
| Cod protein hydrolysate supplement | Active comparator | Participants will consume 18 g of the cod protein supplement each day for 12 weeks. Receives: Dietary Supplement: Cod protein hydrolysate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the cardiovascular index (triacylglycerol/high density lipoprotein (HDL)-cholesterol × waist/hip ratio)
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.
Measured: Baseline to 12 weeks
Secondary outcomes (18)
Changes in the Quick1 index, a surrogate marker of insulin sensitivity
Measured in serum and calculated as 1 / (log(fasting insulin μU/mL) + log(fasting glucose mg/dL)
Measured: Baseline to 12 weeks
Changes in fasting insulin
Measured in serum
Measured: Baseline to 12 weeks
Changes in fasting insulin C-peptide
Measured in serum
Measured: Baseline to 12 weeks
Changes in fasting glucose
Measured in serum
Measured: Baseline to 12 weeks
Changes in total cholesterol
Measured in serum
Measured: Baseline to 12 weeks
Changes in non-high density lipoprotein (HDL) cholesterol
Measured in serum
Measured: Baseline to 12 weeks
Changes in non-esterified fatty acids (NEFA)
Measured in serum
Measured: Baseline to 12 weeks
Changes in triacylglycerol (TAG)
Measured in serum
Measured: Baseline to 12 weeks
Changes in gut microbiota composition
Measured by 16S sequencing
Measured: Baseline to 12 weeks
Changes in short chained fatty acids (SCFA)
Faecal SCFA concentrations calculated as (mmol/L) × wet faecal weight x faecal moisture content (g/100 g) × 10
Measured: Baseline to 12 weeks
Changes in fat mass/fat free mass ratio
Body composition measured by bioimpedance analysis
Measured: Baseline to 12 weeks
Changes in waist-hip ratio
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
Measured: Baseline to 12 weeks
Changes in waist-to-height ratio (WHtR)
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.
Measured: Baseline to 12 weeks
Changes in blood pressure
Blood pressure measurement will be performed manually by a trained nurse using standard equipment
Measured: Baseline to 12 weeks
Changes in heart rate
Heart rate will be determined manually by a trained nurse
Measured: Baseline to 12 weeks
Changes in glucagon-like peptide 1 (GLP-1, hormone involved in appetite and metabolism regulation)
Measured in plasma by ELISA (enzyme-linked immunosorbent assay)
Measured: Baseline to 12 weeks
Changes in gastric inhibitory polypeptide (GIP, hormone involved in metabolism regulation)
Measured in plasma by ELISA (enzyme-linked immunosorbent assay)
Measured: Baseline to 12 weeks
Changes in ghrelin (hormone involved in appetite regulation)
Measured in plasma by ELISA (enzyme-linked immunosorbent assay)
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start1 Feb 2021
- Primary completion15 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy DietStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double blind, placebo controlled clinical study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Collaborators
- Haukeland University Hospital, Alesund Hospital, Norwegian University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Rolf K Berge, PhD, Study director, University of Bergen, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05149079
- Sponsor's protocol ID
- FHF-Study
- Acronym
- MARPEP
- Status last verified
- Nov 2021
- First submitted
- 9 Mar 2021
- Last updated
- 8 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 22361192Erdmann 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.
PubMed 18495464
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double Blind, Placebo Controlled Clinical Study to Investigate the Effect of a Marine Protein Hydrolysate in Healthy Adults
- ClinicalTrials.gov ID
- NCT05149079
- Acronym / sponsor ID
- MARPEP / FHF-Study
- Conditions
- Healthy Diet
- Keywords
- Cardiovascular disease risk, Protein supplementation, Metabolic health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- Haukeland University Hospital, Alesund Hospital, Norwegian University of Science and Technology
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 15 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 8 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized, double blind, controlled trial investigates changes in the cardiovascular index (triacylglycerol/HDL-cholesterol × waist/hip ratio) after 12 weeks of marine protein hydrolysate (MPH) or whey protein powder (placebo) supplementation in adult healthy persons. Additionally, the study investigates potential effects on plasma parameters of metabolic health including lipids, glucose, inflammatory parameters and redox state, as well as associations between dietary MPH and body weight, abdominal obesity, body composition, and gut microbiota composition. Finally, putative end-products of diet-microbial interactions (TMAO and short-chain fatty acids) with CVD risk factors and biomarkers of mitochondrial function are examined.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double blind, placebo controlled clinical study
| Arm | Type | Receives |
|---|---|---|
| Placebo (whey protein supplement) | Placebo comparator | Dietary Supplement: PlaceboParticipants will consume 18 g of the placebo whey protein supplement each day for 12 weeks. |
| Cod protein hydrolysate supplement | Active comparator | Dietary Supplement: Cod protein hydrolysateParticipants will consume 18 g of the cod protein supplement each day for 12 weeks. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cod protein hydrolysateRest 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. | Dietary supplement | Cod protein hydrolysate supplement |
| PlaceboAlso: Whey protein powderWhey protein powder, commercially available | Dietary supplement | Placebo (whey protein supplement) |
Primary outcome
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.
18 secondary outcomes
Changes in the Quick1 index, a surrogate marker of insulin sensitivity
Time frame: Baseline to 12 weeks
Changes in fasting insulin
Time frame: Baseline to 12 weeks
Changes in fasting insulin C-peptide
Time frame: Baseline to 12 weeks
Changes in fasting glucose
Time frame: Baseline to 12 weeks
Changes in total cholesterol
Time frame: Baseline to 12 weeks
Changes in non-high density lipoprotein (HDL) cholesterol
Time frame: Baseline to 12 weeks
Changes in non-esterified fatty acids (NEFA)
Time frame: Baseline to 12 weeks
Changes in triacylglycerol (TAG)
Time frame: Baseline to 12 weeks
Changes in gut microbiota composition
Time frame: Baseline to 12 weeks
Changes in short chained fatty acids (SCFA)
Time frame: Baseline to 12 weeks
Changes in fat mass/fat free mass ratio
Time frame: Baseline to 12 weeks
Changes in waist-hip ratio
Time frame: Baseline to 12 weeks
Changes in waist-to-height ratio (WHtR)
Time frame: Baseline to 12 weeks
Changes in blood pressure
Time frame: Baseline to 12 weeks
Changes in heart rate
Time frame: 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
Changes in gastric inhibitory polypeptide (GIP, hormone involved in metabolism regulation)
Time frame: Baseline to 12 weeks
Changes in ghrelin (hormone involved in appetite regulation)
Time frame: Baseline to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2021.
- Background: PubMed 22361192Kim 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.
- Background: PubMed 18495464Erdmann 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rolf K Berge, PhD study director
University of Bergen, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cod protein hydrolysate in people with Healthy Diet, run by University of Bergen at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the cardiovascular index (triacylglycerol/high density lipoprotein (HDL)-cholesterol × waist/hip ratio) (time frame: Baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05149079, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2021.