PrediabetesBONITONCT02668159
Pilot Study on Metabolic Effects of Fish Peptides and Vitamin D
A study testing Fish peptide supplement, Vitamin D supplement and Fish peptide + Vitamin D3 supplements in people with Prediabetes and Insulin Resistance, run by Laval University at 1 site in Canada.
Trial summary
The overall goal of this study is to investigate the effects and the mechanisms of action of a fish peptide and vitamin D on glucose metabolism, insulin secretion, and cardiometabolic risk profile in overweight men. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prediabetes, Insulin Resistance
- What is being tested?
- Fish peptide supplement, Vitamin D supplement and Fish peptide + Vitamin D3 supplements
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2015to Dec 2017
- 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 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- overweight (BMI 25-40 kg/m2)
- fasting triglycerides ≥ 1.5 mmol/L
- fasting insulin ≥ 60 pmol/L
- non-smoking
- stable weight in the past 3 months
Who cannot join
- diabetes
- chronic diseases
- taking drugs that could affect glucose or lipid metabolism
- taking dietary supplements or natural health products
- major surgery 3 months prior to the study
- fish or seafood allergy
- lactose intolerance
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institute of Nutrition and Functional Foods (INAF), Laval University
Québec, G1V 0A6
About this study
Official title: Cardiometabolic Health Effects and Mechanisms of Action of Fish Nutrients
The overall goal of this study is to investigate the effects and the mechanisms of action of a fish peptide and vitamin D on glucose metabolism, insulin secretion, and cardiometabolic risk profile in overweight men. Transcriptomic and metabolomic approaches will be used to study the acute physiological effects of fish nutrients and to discover gene/metabolite networks that underlie these effects.
Read the detailed description
Sedentary lifestyle and excess calorie intake have contributed to a dramatic increase in the occurrence of obesity, metabolic syndrome (MetS), type 2 diabetes (T2D) and cardiovascular disease (CVD) The first step in reducing the excessive CVD risk associated with the presence of the MetS is the adoption of a healthier lifestyle. A balanced diet, including high-nutritive and low-energy foods such as fish, is an important component of a healthy diet. Fish is a major source of n-3 PUFA, high-quality protein, and other essential nutrients such as vitamin D. Fish consumption may therefore improve the components of the MetS and reduce the incidence of T2D and CVD in obese subjects.The foundation of this project stems from the well-recognized fact that few Canadians meet the weekly dietary recommendation for fish consumption (i.e. 2 servings/week) and thus intakes of both n-3 polyunsaturated fatty acid (PUFA) and fish protein are low in the general population, and even lower in obese subjects. Since some people simply dislike fish and because certain types of fish contain toxic contaminants, including heavy metals and environmental pollutants, fish consumption remains low. Therefore, dietary choices limit intake of its key nutrients, thus increasing risk for MetS, T2D and CVD. Also, fish is one of the richest food sources of dietary vitamin D which may also contribute to the health benefits of fish consumption. Indeed, it is currently estimated that ∼40% of Canadians have low serum 25-hydroxyvitamin D [25(OH)D] concentrations (≤50 nM) and that ∼70% are below 75 nM. In addition, obesity is an important risk factor for low serum 25(OH)D.The main objective of this study is to investigate the acute effects and mechanisms of action of fish peptide and vitamin D on glucose metabolism, parameters of insulin sensibility and secretion, and cardiometabolic risk profile in overweight men.
A four-arm randomized crossover design will be used to test the metabolic effects of consuming prior to a 3h-oral glucose tolerance test (OGTT), supplements containing either fish peptide (3 grams), vitamin D3 (1000 IU), a combination of fish peptide + vitamin D3 or a placebo.
- Conditions
- Prediabetes, Insulin Resistance
- Being tested
- Fish peptide supplement, Vitamin D supplement, Fish peptide + Vitamin D3 supplements, Placebo
- Medical subject headings
- Prediabetic State, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish peptide supplementDietary supplement
6 capsules of fish peptide supplement (3g/each) administered prior to one of the OGTT
Vitamin D supplementDietary supplement
1 tablet of vitamin D3 (1000 UI) administered prior to one of the OGTT
Fish peptide + Vitamin D3 supplementsDietary supplement
6 capsules of fish peptide (3g/each) + 1 tablet of vitamin D3 (1000 UI) administered prior to one of the OGTT
PlaceboDietary supplement
7 tablets of placebos administered prior to one the OGTT
| Study group | Role | What they receive |
|---|---|---|
| Fish peptide | Experimental | Not described Receives: Dietary Supplement: Fish peptide supplement |
| Vitamin D | Experimental | Not described Receives: Dietary Supplement: Vitamin D supplement |
| Fish peptide + Vitamin D | Experimental | Not described Receives: Dietary Supplement: Fish peptide + Vitamin D3 supplements |
| Control | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum glucose area under the curve (Glucose AUC)
The area under the curve for serum glucose concentration is calculated from 0-180min after 75g glucose is ingested
Measured: 0-180 min
Secondary outcomes (6)
Serum insulin area under the curve (Insulin AUC)
Area under the curve for serum insulin
Measured: 0-180 min
Serum C-peptide area under the curve (C-peptide AUC)
Area under the curve for serum C-peptide
Measured: 0-180 min
Serum triglycerides concentrations
changes in the triglycerides concentration at each time point of the OGTT
Measured: -15, 0, 15, 30, 60, 120, 180 min post 75g glucose
Serum 25(OH)D concentrations
Changes in the 25(OH)D concentration measured before each OGTT
Measured: 4 weeks
Cardiometabolic risk profile in serum
Changes in cardiometabolic profile measured in serum before each OGTT
Measured: 4 weeks
Gene expression profile
peripheral blood mononuclear cells (PBMCs) gene expression
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study startAug 2015
- Primary completionDec 2016
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Marie-Claude Vohl, Laval University
- Investigators
- Marie-Claude Vohl, Principal investigator, Instute of Nutrition and Functional Foods, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02668159
- Sponsor's protocol ID
- BONITO 2015-090
- Acronym
- BONITO
- Status last verified
- Jul 2021
- First submitted
- 1 Sep 2015
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiometabolic Health Effects and Mechanisms of Action of Fish Nutrients
- ClinicalTrials.gov ID
- NCT02668159
- Acronym / sponsor ID
- BONITO / BONITO 2015-090
- Conditions
- Prediabetes, Insulin Resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Aug 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 29 Jan 2016 (estimated)
- 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 overall goal of this study is to investigate the effects and the mechanisms of action of a fish peptide and vitamin D on glucose metabolism, insulin secretion, and cardiometabolic risk profile in overweight men. Transcriptomic and metabolomic approaches will be used to study the acute physiological effects of fish nutrients and to discover gene/metabolite networks that underlie these effects.
Detailed description
Sedentary lifestyle and excess calorie intake have contributed to a dramatic increase in the occurrence of obesity, metabolic syndrome (MetS), type 2 diabetes (T2D) and cardiovascular disease (CVD) The first step in reducing the excessive CVD risk associated with the presence of the MetS is the adoption of a healthier lifestyle. A balanced diet, including high-nutritive and low-energy foods such as fish, is an important component of a healthy diet. Fish is a major source of n-3 PUFA, high-quality protein, and other essential nutrients such as vitamin D. Fish consumption may therefore improve the components of the MetS and reduce the incidence of T2D and CVD in obese subjects.The foundation of this project stems from the well-recognized fact that few Canadians meet the weekly dietary recommendation for fish consumption (i.e. 2 servings/week) and thus intakes of both n-3 polyunsaturated fatty acid (PUFA) and fish protein are low in the general population, and even lower in obese subjects. Since some people simply dislike fish and because certain types of fish contain toxic contaminants, including heavy metals and environmental pollutants, fish consumption remains low. Therefore, dietary choices limit intake of its key nutrients, thus increasing risk for MetS, T2D and CVD. Also, fish is one of the richest food sources of dietary vitamin D which may also contribute to the health benefits of fish consumption. Indeed, it is currently estimated that ∼40% of Canadians have low serum 25-hydroxyvitamin D [25(OH)D] concentrations (≤50 nM) and that ∼70% are below 75 nM. In addition, obesity is an important risk factor for low serum 25(OH)D.The main objective of this study is to investigate the acute effects and mechanisms of action of fish peptide and vitamin D on glucose metabolism, parameters of insulin sensibility and secretion, and cardiometabolic risk profile in overweight men.
A four-arm randomized crossover design will be used to test the metabolic effects of consuming prior to a 3h-oral glucose tolerance test (OGTT), supplements containing either fish peptide (3 grams), vitamin D3 (1000 IU), a combination of fish peptide + vitamin D3 or a placebo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Fish peptide | Experimental | Dietary Supplement: Fish peptide supplement |
| Vitamin D | Experimental | Dietary Supplement: Vitamin D supplement |
| Fish peptide + Vitamin D | Experimental | Dietary Supplement: Fish peptide + Vitamin D3 supplements |
| Control | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- overweight (BMI 25-40 kg/m2)
- fasting triglycerides ≥ 1.5 mmol/L
- fasting insulin ≥ 60 pmol/L
- non-smoking
- stable weight in the past 3 months
Key exclusion criteria (7 listed)
- diabetes
- chronic diseases
- taking drugs that could affect glucose or lipid metabolism
- taking dietary supplements or natural health products
- major surgery 3 months prior to the study
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 |
|---|---|---|
| Fish peptide supplement6 capsules of fish peptide supplement (3g/each) administered prior to one of the OGTT | Dietary supplement | Fish peptide |
| Vitamin D supplement1 tablet of vitamin D3 (1000 UI) administered prior to one of the OGTT | Dietary supplement | Vitamin D |
| Fish peptide + Vitamin D3 supplements6 capsules of fish peptide (3g/each) + 1 tablet of vitamin D3 (1000 UI) administered prior to one of the OGTT | Dietary supplement | Fish peptide + Vitamin D |
| Placebo7 tablets of placebos administered prior to one the OGTT | Dietary supplement | Control |
Primary outcome
Serum glucose area under the curve (Glucose AUC)
Time frame: 0-180 min
The area under the curve for serum glucose concentration is calculated from 0-180min after 75g glucose is ingested
6 secondary outcomes
Serum insulin area under the curve (Insulin AUC)
Time frame: 0-180 min
Serum C-peptide area under the curve (C-peptide AUC)
Time frame: 0-180 min
Serum triglycerides concentrations
Time frame: -15, 0, 15, 30, 60, 120, 180 min post 75g glucose
Serum 25(OH)D concentrations
Time frame: 4 weeks
Cardiometabolic risk profile in serum
Time frame: 4 weeks
Gene expression profile
Time frame: 4 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 7 Jul 2021.
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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.
Marie-Claude Vohl principal investigator
Instute of Nutrition and Functional Foods, Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fish peptide supplement, Vitamin D supplement and Fish peptide + Vitamin D3 supplements in people with Prediabetes and Insulin Resistance, run by Laval University at 1 site in Canada.
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 5 inclusion and 7 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 7 Jul 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 Canada. 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?
Serum glucose area under the curve (Glucose AUC) (time frame: 0-180 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jul 2021.