Healthy VolunteersMPH-BSNCT03669796
Marine Protein Hydrolysate as Dietary Supplement in Elderly Part I
A study testing Marine protein hydrolysate (mph) in people with Healthy Volunteers, run by Helse Møre og Romsdal HF at 2 sites in Norway.
Trial summary
The aim of this study is to investigate the potential effect of a marine protein hydrolysate (MPH) supplement before a meal on postprandial glucose tolerance in healthy subjects, to achieve more knowledge on this presumed beneficial, blood glucose lowering effect Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Marine protein hydrolysate (mph)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 2 sitesNorway
- Study dates
- 27 Nov 2017to 28 Feb 2018
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Body mass index (BMI) 20-30
Who cannot join
- Suspected allergies against fish or shellfish
- Low or unstable blood pressure
- Diabetes mellitus, treated pharmacological
- Chronic diseases or therapies that is likely to interfere with the evaluation of study results
- Acute infections (may be reconsidered for inclusion at a later time)
- Allergic to milk, confirmed diagnose
Show all 9Show fewer
- Pregnancy
- Women who are breast-feeding infants
- 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: A Study of the Effects of Marine Protein Hydrolysate as Dietary Supplement on the Regulation of Postprandial Blood Glucose Metabolism in Healthy Subjects
The aim of this study is to investigate the potential effect of a marine protein hydrolysate (MPH) supplement before a meal on postprandial glucose tolerance in healthy subjects, to achieve more knowledge on this presumed beneficial, blood glucose lowering effect
Read the detailed description
To further investigate the effects of MPH in a single dose of 20 mg/kg of body weight on postprandial blood glucose, insulin and GLP-1 (as markers of glucose metabolism) in healthy, active middle-aged to elderly subjects - age 40-65 years.
- Conditions
- Healthy Volunteers
- Being tested
- Marine protein hydrolysate (mph), Control
- Keywords
- Dietary Supplements, Fish Proteins, Protein Hydrolysates, Aged
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Marine protein hydrolysate (mph)Dietary supplement
Marine (Cod) protein hydrolysate
ControlDietary supplement
Maltodextrin/Casein
| Study group | Role | What they receive |
|---|---|---|
| supplementary Marine protein hydrolysate | Experimental | 20 mg powder per kg body weight of Marine protein hydrolysate (MPH) Receives: Dietary Supplement: Marine protein hydrolysate (mph) |
| control | Placebo comparator | 20 mg powder per kg body weight of casein/maltodextrin Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose
Postprandial glucose (mmol/L) change on each day of intervention
Measured: First sample fasting baseline, thereafter repeated samples every 20 minutes (i.e.20, 40, 60, 80, 100,120,140 minutes after baseline), last at 200 minutes after baseline.
Secondary outcomes (4)
Insulin
Postprandial Insulin (mIE/L) - change on each day of intervention
Measured: First sample fasting baseline, thereafter repeated samples every 20 minutes (i.e.20, 40, 60, 80, 100,120,140 minutes after baseline), last at 200 minutes after baseline
Hormon 1
Glucagon like peptide 1 (GLP-1) pmol/l change on each day of intervention
Measured: First sample fasting baseline, thereafter repeated samples (i.e.20, 40, 60, 100 minutes after baseline), last at 200 minutes after baseline
Visual analogue scale (VAS)
Assessed by questionnaire VAS, scale from 0-10, where 0 is minimum score and 10 is the maximum score, reported e.g. as a total score of 7. The higher the reported value is the worse outcome.
Measured: First (baseline) symptomscore (as described above) measured fasting , thereafter repeated symptom score i.e. at 20, 40 minutes after baseline, last symptom score measure at 200 minutes after baseline
KANE, symptom score
Assessed by questionaire KANE (family name) , scale from 0-10, where 0 is minimum score and 10 is the maximum score, reported e.g. as a total score of 7. The higher the reported value is the worse outcome.
Measured: First (baseline) symptom score (as described above) measured fasting and the next measure at 200 minutes after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start27 Nov 2017
- Primary completion28 Feb 2018
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A double-blind crossover trial, including two different study days, with 4-7 days wash-out (WO) period in between. The intervention implemented 20 mg of MPH per kg body weight (test material) or control (casein).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Møre og Romsdal HF
- Sponsor type
- Other government
- Collaborators
- Haukeland University Hospital
- Responsible party
- Sponsor
- Investigators
- Dag Arne Lihaug Hoff, MD, PhD, Study director, Møre & Romsdal Hospital Trust, Ålesund Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03669796
- Sponsor's protocol ID
- 2017/1794
- Acronym
- MPH-BS
- Status last verified
- Nov 2019
- First submitted
- 2 Jul 2018
- Last updated
- 14 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dale HF, Jensen C, Hausken T, Lied E, Hatlebakk JG, Bronstad I, Lihaug Hoff DA, Lied GA. Effect of a cod protein hydrolysate on postprandial glucose metabolism in healthy subjects: a double-blind cross-over trial. J Nutr Sci. 2018 Nov 28;7:e33. doi: 10.1017/jns.2018.23. eCollection 2018.
PubMed 30524707Dale HF, Jensen C, Hausken T, Lied E, Hatlebakk JG, Bronstad I, Hoff DAL, Lied GA. Erratum: Effect of a cod protein hydrolysate on postprandial glucose metabolism in healthy subjects: a double-blind cross-over trial - CORRIGENDUM. J Nutr Sci. 2019 Jan 18;8:e1. doi: 10.1017/jns.2018.30. eCollection 2019.
PubMed 30719283Dale HF, Jensen C, Hausken T, Lied E, Hatlebakk JG, Bronstad I, Hoff DAL, Lied GA. Acute effect of a cod protein hydrolysate on postprandial acylated ghrelin concentration and sensations associated with appetite in healthy subjects: a double-blind crossover trial. Food Nutr Res. 2019 Oct 22;63. doi: 10.29219/fnr.v63.3507. eCollection 2019.
PubMed 31692759
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Effects of Marine Protein Hydrolysate as Dietary Supplement on the Regulation of Postprandial Blood Glucose Metabolism in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03669796
- Acronym / sponsor ID
- MPH-BS / 2017/1794
- Conditions
- Healthy Volunteers
- Keywords
- Dietary Supplements, Fish Proteins, Protein Hydrolysates, Aged
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Helse Møre og Romsdal HFOther government
- Collaborators
- Haukeland University Hospital
- Study start
- 27 Nov 2017 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 13 Sep 2018 (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.
The aim of this study is to investigate the potential effect of a marine protein hydrolysate (MPH) supplement before a meal on postprandial glucose tolerance in healthy subjects, to achieve more knowledge on this presumed beneficial, blood glucose lowering effect
Detailed description
To further investigate the effects of MPH in a single dose of 20 mg/kg of body weight on postprandial blood glucose, insulin and GLP-1 (as markers of glucose metabolism) in healthy, active middle-aged to elderly subjects - age 40-65 years.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A double-blind crossover trial, including two different study days, with 4-7 days wash-out (WO) period in between. The intervention implemented 20 mg of MPH per kg body weight (test material) or control (casein).
| Arm | Type | Receives |
|---|---|---|
| supplementary Marine protein hydrolysate | Experimental | Dietary Supplement: Marine protein hydrolysate (mph)20 mg powder per kg body weight of Marine protein hydrolysate (MPH) |
| control | Placebo comparator | Dietary Supplement: Control20 mg powder per kg body weight of casein/maltodextrin |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Signed informed consent
- Body mass index (BMI) 20-30
Key exclusion criteria (9 listed)
- Suspected allergies against fish or shellfish
- Low or unstable blood pressure
- Diabetes mellitus, treated pharmacological
- Chronic diseases or therapies that is likely to interfere with the evaluation of study results
- Acute infections (may be reconsidered for inclusion at a later time)
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 |
|---|---|---|
| Marine protein hydrolysate (mph)Marine (Cod) protein hydrolysate | Dietary supplement | supplementary Marine protein hydrolysate |
| ControlMaltodextrin/Casein | Dietary supplement | control |
Primary outcome
Glucose
Time frame: First sample fasting baseline, thereafter repeated samples every 20 minutes (i.e.20, 40, 60, 80, 100,120,140 minutes after baseline), last at 200 minutes after baseline.
Postprandial glucose (mmol/L) change on each day of intervention
4 secondary outcomes
Insulin
Time frame: First sample fasting baseline, thereafter repeated samples every 20 minutes (i.e.20, 40, 60, 80, 100,120,140 minutes after baseline), last at 200 minutes after baseline
Hormon 1
Time frame: First sample fasting baseline, thereafter repeated samples (i.e.20, 40, 60, 100 minutes after baseline), last at 200 minutes after baseline
Visual analogue scale (VAS)
Time frame: First (baseline) symptomscore (as described above) measured fasting , thereafter repeated symptom score i.e. at 20, 40 minutes after baseline, last symptom score measure at 200 minutes after baseline
KANE, symptom score
Time frame: First (baseline) symptom score (as described above) measured fasting and the next measure at 200 minutes after baseline
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 14 Nov 2019.
- Results publication: PubMed 30524707Dale HF, Jensen C, Hausken T, Lied E, Hatlebakk JG, Bronstad I, Lihaug Hoff DA, Lied GA. Effect of a cod protein hydrolysate on postprandial glucose metabolism in healthy subjects: a double-blind cross-over trial. J Nutr Sci. 2018 Nov 28;7:e33. doi: 10.1017/jns.2018.23. eCollection 2018.
- Results publication: PubMed 30719283Dale HF, Jensen C, Hausken T, Lied E, Hatlebakk JG, Bronstad I, Hoff DAL, Lied GA. Erratum: Effect of a cod protein hydrolysate on postprandial glucose metabolism in healthy subjects: a double-blind cross-over trial - CORRIGENDUM. J Nutr Sci. 2019 Jan 18;8:e1. doi: 10.1017/jns.2018.30. eCollection 2019.
- Results publication: PubMed 31692759Dale HF, Jensen C, Hausken T, Lied E, Hatlebakk JG, Bronstad I, Hoff DAL, Lied GA. Acute effect of a cod protein hydrolysate on postprandial acylated ghrelin concentration and sensations associated with appetite in healthy subjects: a double-blind crossover trial. Food Nutr Res. 2019 Oct 22;63. doi: 10.29219/fnr.v63.3507. eCollection 2019.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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
Møre & Romsdal Hospital Trust, Ålesund Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Marine protein hydrolysate (mph) in people with Healthy Volunteers, 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 2 inclusion and 9 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 14 Nov 2019. 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: First sample fasting baseline, thereafter repeated samples every 20 minutes (i.e.20, 40, 60, 80, 100,120,140 minutes after baseline), last at 200 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 NCT03669796, which also lists 3 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 14 Nov 2019.