Metabolic SyndromeMPH_MetSNCT03807752
Marin Protein Hydrolysate and Metabolic Syndrome
A study testing MPH_active in people with Metabolic Syndrome, run by Helse Møre og Romsdal HF at 2 sites in Norway.
Trial summary
Overweight and obesity are increasing global health problems and the most important contributors to morbidity and mortality. The maintenance of long-term weight loss is difficult, and individuals often regain weight after an intervention program is finished. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- MPH_active
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 2 sitesNorway
- Study dates
- 15 Feb 2019to 30 Apr 2020
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40-70 years
- BMI 27-35 kg/m2
- Signed informed consent
- MetS as defined by the presence of at least 3 of the 5 following criteria*:
- Elevated waist circumference ≥ 94 cm (M), ≥ 80 cm (F)
- Elevated triglycerides ≥ 1.7 mmol/L (150 mg/dL)
Show all 10Show fewer
- Elevated fasting glucose ≥ 5.5 mmol/L (100 mg/dL)
- Elevated blood pressure S ≥ 130 and/or D ≥85 mmHg
- Reduced HDL-cholesterol < 1.0 mmol/L (40 mg/dL) (M) <1.3 mmol/L (50 mg/dL) (F)
- The International Diabetes Foundations (IDF) cut-off points are used.
Who cannot join
- Suspected allergy against fish or shellfish
- Acute infections (may be reconsidered for inclusion at a later time)
- Chronic disease or therapies that is likely to interfere with the evaluation study results
- Pregnancy, lactation or planning pregnancy during study period
- Substance misuse
- Inability or unwillingness to comply with the requirements of study procedures
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Ålesund Hospital, Helse Møre og Romsdal HF
Ålesund
Haukeland University Hospital
Bergen
About this study
Official title: The Effect of Supplementation With a Marine Protein Hydrolysate in Patients With Metabolic Syndrome
Overweight and obesity are increasing global health problems and the most important contributors to morbidity and mortality. The maintenance of long-term weight loss is difficult, and individuals often regain weight after an intervention program is finished. It is of interest to find ways to prevent and alleviate metabolic syndrome (MetS), beyond the known effects of lifestyle modification and weight loss. Fish has been proposed as a food that may have favorable effects on metabolic health. There is evidence that cod, and other marine fish, may contain bioactive peptides that have potentially important health effects in humans. The aim of this study is to investigate the effect of adding a marine protein hydrolysate (MPH) supplement to the diet over an 8-week period in a group of adults with established MetS. The investigators expect that this will lead to beneficial changes in the components of MetS and to an overall healthier metabolic profile.
Read the detailed description
Overweight and obesity are increasing global health problems and the most important contributors to morbidity and mortality. Obesity (abdominal obesity), together with hyperglycemia, dyslipidemia and hypertension forms a cluster of risk factors that is called the metabolic syndrome (MetS). The first-line therapy for MetS is lifestyle intervention - education on a healthy lifestyle leading to a focus on physical activity and diet, which will improve risk factors closely linked to MetS. The maintenance of long-term weight loss is difficult, and individuals often regain weight after an intervention program stops. It is of interest to find ways to prevent and alleviate MetS, beyond the known effects of lifestyle modification and weight loss. Fish has been proposed as a food that may have favorable effects on metabolic health. Previous intervention studies with fish protein in humans and rodents have shown improved insulin sensitivity and glucose tolerance, reduced cholesterol levels in plasma and reduced blood pressure. Intervention studies investigating the effect of cod have mainly focused on the health effect of consuming the whole fillet. Studies on the remaining part of the fish, the residual material, primarily used for production of animal feed, are scarce. There is evidence that cod, and other marine fish, may contain bioactive peptides that have potentially important health effects in humans. Therefore, it is of interest to investigate the possible effect of a daily supplement of marine protein hydrolysate (MPH), taken over a longer period, in a group of patients with abnormal glucose control. The aim of this study is to investigate the effect of adding a MPH supplement to the diet over an 8-week period in a group of adults with established MetS. The investigators expect that supplementation with MPH will lead to beneficial changes in the components of MetS and an overall healthier metabolic profile.
- Conditions
- Metabolic Syndrome
- Being tested
- MPH_active, MPH_placebo
- Keywords
- Dietary Supplements, Fish Proteins, Protein Hydrolysates
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MPH_activeDietary supplement
One daily intake at breakfast of supplementary marine protein hydrolysate (MPH), a dosage of X mg, duration 8 weeks. The form is powder, flavored with lemon, and to be mixed with 100 ml water. Random sequence of arms.
MPH_placeboDietary supplement
One daily intake at breakfast of supplementary placebo, a dosage of X mg, duration 8 weeks. The form is powder, flavored with lemon, and to be mixed with 100 ml water.
| Study group | Role | What they receive |
|---|---|---|
| MPH_active | Active comparator | Daily intake at breakfast of supplementary marine protein hydrolysate (MPH). Random sequence of arms. Receives: Dietary Supplement: MPH_active |
| MPH_placebo | Placebo comparator | Daily intake at breakfast of supplementary placebo. Random sequence of arms. Receives: Dietary Supplement: MPH_placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose
Postprandial glucose (mmol/L) change at baseline and after 8 weeks on intervention.
Measured: At baseline and after 8 weeks, the first sample fasted, thereafter repeated samples every 20 minutes (i.e. -15, 0, 20, 40, 60, 80, 100,120 minutes after baseline).
Secondary outcomes (7)
Insulin
Postprandial insulin (mmol/L) change at baseline and after 8 weeks on intervention.
Measured: At baseline and after 8 weeks, the first sample fasted, thereafter repeated samples every 20 minutes (i.e. -15, 0, 20, 40, 60, 80, 100,120 minutes after baseline).
Hormon hunger 1
Glucagon like peptide 1 (GLP-1) pmol/l at baseline and after 8 weeks on intervention.
Measured: At baseline and after 8 weeks, the first sample fasted, thereafter repeated samples (i.e - 15, 0, 20, 40, 80, 120 minutes after baseline).
Hormon hunger 2
Ghrelin at baseline and after 8 weeks on intervention.
Measured: At baseline and after 8 weeks, the first sample fasted, thereafter repeated samples (i.e - 15, 0, 20, 40, 80, 120 minutes after baseline).
Body composition 1
Bioimpedance at baseline and after 8 weeks on intervention.
Measured: At baseline and after 8 weeks.
Body composition 2
Body mass index at baseline and after 8 weeks on intervention.
Measured: At baseline and after 8 weeks.
Body composition 3
Waist circumference at baseline and after 8 weeks on intervention.
Measured: First at baseline and after 8 weeks.
Glucose_met
Glycated hemoglobin (HBA1c) at baseline and after 8 weeks on intervention.
Measured: At baseline and after 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2019
- Study start15 Feb 2019
- Primary completion31 Dec 2019
- Study completion30 Apr 2020
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 Metabolic SyndromeStudies 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
- A parallel group randomized, controlled clinical trial for eight weeks
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Møre og Romsdal HF
- Sponsor type
- Other government
- Collaborators
- Haukeland University Hospital, University of Bergen
- Responsible party
- Sponsor
- Investigators
- Dag Arne Lihaug Hoff, MD, PhD, Study director, Helse Møre og Romsdal Hospital Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03807752
- Sponsor's protocol ID
- 2018/2163
- Acronym
- MPH_MetS
- Status last verified
- Dec 2020
- First submitted
- 15 Jan 2019
- Last updated
- 22 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jensen C, Dale HF, Hausken T, Hatlebakk JG, Bronstad I, Lied GA, Hoff DAL. The Effect of Supplementation with Low Doses of a Cod Protein Hydrolysate on Satiety Hormones and Inflammatory Biomarkers in Adults with Metabolic Syndrome: A Randomized, Double-Blind Study. Nutrients. 2020 Nov 8;12(11):3421. doi: 10.3390/nu12113421.
PubMed 33171589Jensen C, Fjeldheim Dale H, Hausken T, Hatlebakk JG, Bronstad I, Lied GA, Hoff DAL. Supplementation with Low Doses of a Cod Protein Hydrolysate on Glucose Regulation and Lipid Metabolism in Adults with Metabolic Syndrome: A Randomized, Double-Blind Study. Nutrients. 2020 Jul 4;12(7):1991. doi: 10.3390/nu12071991.
PubMed 32635503
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Supplementation With a Marine Protein Hydrolysate in Patients With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT03807752
- Acronym / sponsor ID
- MPH_MetS / 2018/2163
- Conditions
- Metabolic Syndrome
- Keywords
- Dietary Supplements, Fish Proteins, Protein Hydrolysates
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Helse Møre og Romsdal HFOther government
- Collaborators
- Haukeland University Hospital, University of Bergen
- Study start
- 15 Feb 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 17 Jan 2019 (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.
Overweight and obesity are increasing global health problems and the most important contributors to morbidity and mortality. The maintenance of long-term weight loss is difficult, and individuals often regain weight after an intervention program is finished. It is of interest to find ways to prevent and alleviate metabolic syndrome (MetS), beyond the known effects of lifestyle modification and weight loss. Fish has been proposed as a food that may have favorable effects on metabolic health. There is evidence that cod, and other marine fish, may contain bioactive peptides that have potentially important health effects in humans. The aim of this study is to investigate the effect of adding a marine protein hydrolysate (MPH) supplement to the diet over an 8-week period in a group of adults with established MetS. The investigators expect that this will lead to beneficial changes in the components of MetS and to an overall healthier metabolic profile.
Detailed description
Overweight and obesity are increasing global health problems and the most important contributors to morbidity and mortality. Obesity (abdominal obesity), together with hyperglycemia, dyslipidemia and hypertension forms a cluster of risk factors that is called the metabolic syndrome (MetS). The first-line therapy for MetS is lifestyle intervention - education on a healthy lifestyle leading to a focus on physical activity and diet, which will improve risk factors closely linked to MetS. The maintenance of long-term weight loss is difficult, and individuals often regain weight after an intervention program stops. It is of interest to find ways to prevent and alleviate MetS, beyond the known effects of lifestyle modification and weight loss. Fish has been proposed as a food that may have favorable effects on metabolic health. Previous intervention studies with fish protein in humans and rodents have shown improved insulin sensitivity and glucose tolerance, reduced cholesterol levels in plasma and reduced blood pressure. Intervention studies investigating the effect of cod have mainly focused on the health effect of consuming the whole fillet. Studies on the remaining part of the fish, the residual material, primarily used for production of animal feed, are scarce. There is evidence that cod, and other marine fish, may contain bioactive peptides that have potentially important health effects in humans. Therefore, it is of interest to investigate the possible effect of a daily supplement of marine protein hydrolysate (MPH), taken over a longer period, in a group of patients with abnormal glucose control. The aim of this study is to investigate the effect of adding a MPH supplement to the diet over an 8-week period in a group of adults with established MetS. The investigators expect that supplementation with MPH will lead to beneficial changes in the components of MetS and an overall healthier metabolic profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- A parallel group randomized, controlled clinical trial for eight weeks
| Arm | Type | Receives |
|---|---|---|
| MPH_active | Active comparator | Dietary Supplement: MPH_activeDaily intake at breakfast of supplementary marine protein hydrolysate (MPH). Random sequence of arms. |
| MPH_placebo | Placebo comparator | Dietary Supplement: MPH_placeboDaily intake at breakfast of supplementary placebo. Random sequence of arms. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 40-70 years
- BMI 27-35 kg/m2
- Signed informed consent
- MetS as defined by the presence of at least 3 of the 5 following criteria*:
Key exclusion criteria (6 listed)
- Suspected allergy against fish or shellfish
- Acute infections (may be reconsidered for inclusion at a later time)
- Chronic disease or therapies that is likely to interfere with the evaluation study results
- Pregnancy, lactation or planning pregnancy during study period
- Substance misuse
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 |
|---|---|---|
| MPH_activeOne daily intake at breakfast of supplementary marine protein hydrolysate (MPH), a dosage of X mg, duration 8 weeks. The form is powder, flavored with lemon, and to be mixed with 100 ml water. Random sequence of arms. | Dietary supplement | MPH_active |
| MPH_placeboOne daily intake at breakfast of supplementary placebo, a dosage of X mg, duration 8 weeks. The form is powder, flavored with lemon, and to be mixed with 100 ml water. | Dietary supplement | MPH_placebo |
Primary outcome
Glucose
Time frame: At baseline and after 8 weeks, the first sample fasted, thereafter repeated samples every 20 minutes (i.e. -15, 0, 20, 40, 60, 80, 100,120 minutes after baseline).
Postprandial glucose (mmol/L) change at baseline and after 8 weeks on intervention.
7 secondary outcomes
Insulin
Time frame: At baseline and after 8 weeks, the first sample fasted, thereafter repeated samples every 20 minutes (i.e. -15, 0, 20, 40, 60, 80, 100,120 minutes after baseline).
Hormon hunger 1
Time frame: At baseline and after 8 weeks, the first sample fasted, thereafter repeated samples (i.e - 15, 0, 20, 40, 80, 120 minutes after baseline).
Hormon hunger 2
Time frame: At baseline and after 8 weeks, the first sample fasted, thereafter repeated samples (i.e - 15, 0, 20, 40, 80, 120 minutes after baseline).
Body composition 1
Time frame: At baseline and after 8 weeks.
Body composition 2
Time frame: At baseline and after 8 weeks.
Body composition 3
Time frame: First at baseline and after 8 weeks.
Glucose_met
Time frame: At baseline and after 8 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 22 Dec 2020.
- Background: PubMed 33171589Jensen C, Dale HF, Hausken T, Hatlebakk JG, Bronstad I, Lied GA, Hoff DAL. The Effect of Supplementation with Low Doses of a Cod Protein Hydrolysate on Satiety Hormones and Inflammatory Biomarkers in Adults with Metabolic Syndrome: A Randomized, Double-Blind Study. Nutrients. 2020 Nov 8;12(11):3421. doi: 10.3390/nu12113421.
- Results publication: PubMed 32635503Jensen C, Fjeldheim Dale H, Hausken T, Hatlebakk JG, Bronstad I, Lied GA, Hoff DAL. Supplementation with Low Doses of a Cod Protein Hydrolysate on Glucose Regulation and Lipid Metabolism in Adults with Metabolic Syndrome: A Randomized, Double-Blind Study. Nutrients. 2020 Jul 4;12(7):1991. doi: 10.3390/nu12071991.
- 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.
Dag Arne Lihaug Hoff, MD, PhD study director
Helse Møre og Romsdal Hospital Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MPH_active in people with Metabolic Syndrome, run by Helse Møre og Romsdal HF at 2 sites 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 10 inclusion and 6 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 22 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Glucose (time frame: At baseline and after 8 weeks, the first sample fasted, thereafter repeated samples every 20 minutes (i.e. -15, 0, 20, 40, 60, 80, 100,120 minutes after baseline).). 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 NCT03807752, 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 22 Dec 2020.