Insulin ResistancePhase 2NCT01215903
Fish Gelatin Supplement and Omega-3 Supplement in Obese or Overweight Subjects With Insulin Resistance
A Phase 2 study testing Fish gelatin and omega-3 polyunsaturated fatty acid and Omega-3 polyunsaturated fatty acid in people with Insulin Resistance and Type 2 Diabetes, run by Laval University at 1 site in Canada.
Trial summary
The present study was conducted to test whether a fish gelatin supplement combined with an omega-3 polyunsaturated fatty acid supplement can exert beneficial and sex-specific effects on insulin sensitivity, glucose tolerance, indicators of insulin secretion, blood pressure, lipid metabolism, inflammation and energy… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Insulin Resistance, Type 2 Diabetes
- What is being tested?
- Fish gelatin and omega-3 polyunsaturated fatty acid and Omega-3 polyunsaturated fatty acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2007to May 2009
- Phase
- Phase 2
- 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
- overweight or obese (body mass index [BMI] between 25 and 40kg/m2)
- fasting plasma glucose below 7.0mmol/L and 2-h plasma glucose below 11.1mmol/L
- fasting plasma insulin above 90pmol/L
Who cannot join
- Diabetes, chronic, metabolic or acute disease
- Major surgery within the last 3 months
- Significant weight loss (±10%) within the last 6 months
- Any medication-taking known to affect lipid of glucose metabolism
- Allergy, intolerance or dislike of fish
- Smokers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Beneficial Effects of Fish Nutrients on the Obesity-linked Metabolic Syndrome and Cardiovascular Risk Profile
The present study was conducted to test whether a fish gelatin supplement combined with an omega-3 polyunsaturated fatty acid supplement can exert beneficial and sex-specific effects on insulin sensitivity, glucose tolerance, indicators of insulin secretion, blood pressure, lipid metabolism, inflammation and energy intake in obese or overweight insulin-resistant men and women. The investigators hypothesis is that fish gelatin improves insulin sensitivity, glucose tolerance, lipid profile and reduces inflammation in obese or overweight insulin-resistant men and women.
Read the detailed description
An important number of recent epidemiological studies have demonstrated the beneficial effects of marine omega-3 polyunsaturated fatty acids (n-3 PUFA) on cardiovascular disease risk factors such as reduced triglycerides, decreased platelet aggregation, plaque stabilization, antiarrhythmic effects, and reduced blood pressure. Dietary fish protein has also been shown to improve insulin sensitivity by 30% in insulin-resistant obese or overweight human subjects. In addition, an increasing number of studies describe and demonstrate the physiological and metabolic variations between men and women in regard to CVD and their risk factors, including type 2 diabetes, but the data are still limited. In agreement with the recent findings, this study was conducted to evaluate the combined and synergistic effects of omega-3 and fish protein supplements on insulin sensitivity, blood pressure, lipid metabolism and inflammation in obese or overweight insulin-resistant men and women having some or all the metabolic syndrome criteria including a deteriorated lipid profile, high blood pressure and high waist circumference in a free living situation.
- Conditions
- Insulin Resistance, Type 2 Diabetes
- Being tested
- Fish gelatin and omega-3 polyunsaturated fatty acid, Omega-3 polyunsaturated fatty acid
- Medical subject headings
- Insulin Resistance, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish gelatin and omega-3 polyunsaturated fatty acidDietary supplement
Omega-3 polyunsaturated fatty acidDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Fish gelatin and omega-3 | Experimental | Not described Receives: Dietary Supplement: Fish gelatin and omega-3 polyunsaturated fatty acid |
| Omega-3 | Experimental | Not described Receives: Dietary Supplement: Omega-3 polyunsaturated fatty acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
Measured: At 8 weeks
Plasma lipids and lipoproteins
Measured: at 8 weeks
Blood pressure
Measured: At 8 weeks
Plasma and serum inflammatory markers
Measured: At 8 weeks
Secondary outcomes (3)
Glucose tolerance
Measured: At 8 weeks
Energy intake
Measured: At 8 weeks
Fatty acids of phospholipids in skeletal muscle
Measured: At 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2010 (estimated)
- Study startNov 2007
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Advance Foods and Materials Network, Institut des Nutraceutiques et Aliments fonctionnels, Quebec (Clinical nutrition facilities), University of Guelph, Ocean Nutrition Canada, Halifax (in-kind support: omega-3 supplements), Kenney & Ross
- Investigators
- Helene Jacques, PhD, Principal investigator, Laval UniversityAndre Marette, PhD, Principal investigator, Laval UniversityJohn S Weisnagel, MD/FRCPC, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01215903
- Sponsor's protocol ID
- SIRUL-85742
- Status last verified
- Oct 2010
- First submitted
- 5 Oct 2010
- Last updated
- 25 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Beneficial Effects of Fish Nutrients on the Obesity-linked Metabolic Syndrome and Cardiovascular Risk Profile
- ClinicalTrials.gov ID
- NCT01215903
- Acronym / sponsor ID
- SIRUL-85742
- Conditions
- Insulin Resistance, Type 2 Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Advance Foods and Materials Network, Institut des Nutraceutiques et Aliments fonctionnels, Quebec (Clinical nutrition facilities), University of Guelph, Ocean Nutrition Canada, Halifax (in-kind support: omega-3 supplements), Kenney & Ross
- Study start
- Nov 2007
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 7 Oct 2010 (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 present study was conducted to test whether a fish gelatin supplement combined with an omega-3 polyunsaturated fatty acid supplement can exert beneficial and sex-specific effects on insulin sensitivity, glucose tolerance, indicators of insulin secretion, blood pressure, lipid metabolism, inflammation and energy intake in obese or overweight insulin-resistant men and women. The investigators hypothesis is that fish gelatin improves insulin sensitivity, glucose tolerance, lipid profile and reduces inflammation in obese or overweight insulin-resistant men and women.
Detailed description
An important number of recent epidemiological studies have demonstrated the beneficial effects of marine omega-3 polyunsaturated fatty acids (n-3 PUFA) on cardiovascular disease risk factors such as reduced triglycerides, decreased platelet aggregation, plaque stabilization, antiarrhythmic effects, and reduced blood pressure. Dietary fish protein has also been shown to improve insulin sensitivity by 30% in insulin-resistant obese or overweight human subjects. In addition, an increasing number of studies describe and demonstrate the physiological and metabolic variations between men and women in regard to CVD and their risk factors, including type 2 diabetes, but the data are still limited. In agreement with the recent findings, this study was conducted to evaluate the combined and synergistic effects of omega-3 and fish protein supplements on insulin sensitivity, blood pressure, lipid metabolism and inflammation in obese or overweight insulin-resistant men and women having some or all the metabolic syndrome criteria including a deteriorated lipid profile, high blood pressure and high waist circumference in a free living situation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fish gelatin and omega-3 | Experimental | Dietary Supplement: Fish gelatin and omega-3 polyunsaturated fatty acid |
| Omega-3 | Experimental | Dietary Supplement: Omega-3 polyunsaturated fatty acid |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- overweight or obese (body mass index [BMI] between 25 and 40kg/m2)
- fasting plasma glucose below 7.0mmol/L and 2-h plasma glucose below 11.1mmol/L
- fasting plasma insulin above 90pmol/L
Key exclusion criteria (6 listed)
- Diabetes, chronic, metabolic or acute disease
- Major surgery within the last 3 months
- Significant weight loss (±10%) within the last 6 months
- Any medication-taking known to affect lipid of glucose metabolism
- Allergy, intolerance or dislike of fish
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 gelatin and omega-3 polyunsaturated fatty acid | Dietary supplement | Fish gelatin and omega-3 |
| Omega-3 polyunsaturated fatty acid | Dietary supplement | Omega-3 |
Primary outcome
Insulin sensitivity
Time frame: At 8 weeks
Plasma lipids and lipoproteins
Time frame: at 8 weeks
Blood pressure
Time frame: At 8 weeks
Plasma and serum inflammatory markers
Time frame: At 8 weeks
3 secondary outcomes
Glucose tolerance
Time frame: At 8 weeks
Energy intake
Time frame: At 8 weeks
Fatty acids of phospholipids in skeletal muscle
Time frame: At 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 25 Oct 2010.
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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.
Helene Jacques, PhD principal investigator
Laval University
Andre Marette, PhD principal investigator
Laval University
John S Weisnagel, MD/FRCPC principal investigator
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fish gelatin and omega-3 polyunsaturated fatty acid and Omega-3 polyunsaturated fatty acid in people with Insulin Resistance and Type 2 Diabetes, 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 3 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 25 Oct 2010. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Insulin sensitivity (time frame: At 8 weeks). The study lists 4 primary outcomes in all. 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 25 Oct 2010.