HyperglycemiaNCT01768429
The Effect of n-3 Fatty Acids and Fish on Glucose and Lipid Metabolism in Subjects With Impaired Glucose Metabolism
A study testing Fatty fish, Lean Fish and Alpha-linolenic acid in people with Hyperglycemia, run by University of Eastern Finland at 1 site in Finland.
Trial summary
The aim of the project is to examine whether the sources of n-3 fatty acids and fish itself differ in their effects on glucose metabolism, lipid metabolism, blood pressure, and serum inflammatory markers. Lipidomic profiles and gene expression will be used for thorough assessment of the possible clinical changes. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Hyperglycemia
- What is being tested?
- Fatty fish, Lean Fish and Alpha-linolenic acid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteFinland
- Study dates
- Oct 2012to Jun 2014
- 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 25-32 kg/m2
- fasting plasma glucose 5.6-7.0 mmol/l
- 2 h plasma glucose in oral glucose tolerance test <=11 mmol/l
- fasting serum total cholesterol <=7 mmol/l
- fasting serum LDL cholesterol <=5 mmol/l
- fasting serum triglycerides <=4 mmol/l
Who cannot join
- any chronic disease or condition that hamper the ability to follow dietary intervention
- chronic liver, thyroid or kidney disease
- alcohol abuse
- diabetes
- recent weight loss
- recent myocardial infarction
Show all 11Show fewer
- corticosteroid therapy
- psychiatric disorders which need drug treatment
- cancer under treatment
- fish allergy or other extensive food allergies
- exceptional diets (like Atkin's or vegan diet)
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the project is to examine whether the sources of n-3 fatty acids and fish itself differ in their effects on glucose metabolism, lipid metabolism, blood pressure, and serum inflammatory markers. Lipidomic profiles and gene expression will be used for thorough assessment of the possible clinical changes. The study will compare the effects of alpha-linolenic acid containing vegetable oil, fatty fish, lean fish and control diet. The results of this project will help to identify the optimal source of n-3 fatty acids, and reveal the significance of the components of fish other than fatty acids. These data will be useful both nationally and internationally, since highly controlled dietary interventions utilizing new methodology are scarce.
- Conditions
- Hyperglycemia
- Being tested
- Fatty fish, Lean Fish, Alpha-linolenic acid, Control
- Medical subject headings
- Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fatty fishBehavioural
Lean FishBehavioural
Alpha-linolenic acidBehavioural
ControlBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Fatty fish | Experimental | Four fatty fish meals per week Receives: Behavioral: Fatty fish |
| Lean Fish | Experimental | Four lean fish meals per week Receives: Behavioral: Lean Fish |
| Alpha-linolenic acid | Experimental | 10 g of alpha-linolenic acid daily from camelina sativa oil Receives: Behavioral: Alpha-linolenic acid |
| Control diet | Experimental | Limited fish and alpha-linolenic acid intake Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose metabolism assessed by oral glucose tolerance test and frequently sampled intravenous glucose tolerance test
change in glucose metabolism
Measured: Baseline and 12 weeks
Serum lipid profile
Change in serum lipid profile
Measured: Baseline and at 12 weeks
Blood pressure
Change in blood pressure
Measured: Baseline and 12 weeks
Serum inflammatory markers
Change in serum inflammatory markers
Measured: baseline and 12 weeks
Plasma and adipose tissue lipidomic profile
Change in plasma and adipose tissue lipidomic profile
Measured: Baseline and 12 weeks
Plasma and urine metabonomics
Change in plasma and urine metabonomics
Measured: Baseline and 12 weeks
Gene expression in adipose tissue and peripheral blood mononuclear cells
Change in gene expression in adipose tissue and peripheral blood mononuclear cells
Measured: Baseline and 12 weeks
Secondary outcomes (1)
Reverse cholesterol transport
Change in reverse cholesterol transport
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2013 (estimated)
- Study startOct 2012
- Primary completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HyperglycemiaStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Eastern Finland
- Sponsor type
- University, hospital or other
- Collaborators
- Kuopio University Hospital, VTT Technical Research Centre, Finland
- Responsible party
- Sponsor
- Investigators
- Arja Erkkilä, Adjunct Prof, Principal investigator, University of Eastern FinlandUrsula Schwab, Adjunct Prof, Principal investigator, University of Eastern Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01768429
- Sponsor's protocol ID
- ALFAKALA
- Status last verified
- Dec 2014
- First submitted
- 11 Jan 2013
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Meuronen T, Lankinen MA, Fauland A, Shimizu BI, de Mello VD, Laaksonen DE, Wheelock CE, Erkkila AT, Schwab US. Intake of Camelina Sativa Oil and Fatty Fish Alter the Plasma Lipid Mediator Profile in Subjects with Impaired Glucose Metabolism - A Randomized Controlled Trial. Prostaglandins Leukot Essent Fatty Acids. 2020 Aug;159:102143. doi: 10.1016/j.plefa.2020.102143. Epub 2020 May 30.
PubMed 32512364Manninen S, Lankinen M, Erkkila A, Nguyen SD, Ruuth M, de Mello V, Oorni K, Schwab U. The effect of intakes of fish and Camelina sativa oil on atherogenic and anti-atherogenic functions of LDL and HDL particles: A randomized controlled trial. Atherosclerosis. 2019 Feb;281:56-61. doi: 10.1016/j.atherosclerosis.2018.12.017. Epub 2018 Dec 23.
PubMed 30658192Manninen S, Lankinen M, de Mello V, Agren J, Laaksonen D, Schwab U, Erkkila A. The effect of camelina sativa oil and fish intakes on fatty acid compositions of blood lipid fractions. Nutr Metab Cardiovasc Dis. 2019 Jan;29(1):51-61. doi: 10.1016/j.numecd.2018.10.002. Epub 2018 Oct 11.
PubMed 30454883Manninen SM, Lankinen MA, de Mello VD, Laaksonen DE, Schwab US, Erkkila AT. Intake of Fatty Fish Alters the Size and the Concentration of Lipid Components of HDL Particles and Camelina Sativa Oil Decreases IDL Particle Concentration in Subjects with Impaired Glucose Metabolism. Mol Nutr Food Res. 2018 May;62(10):e1701042. doi: 10.1002/mnfr.201701042.
PubMed 29645359
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of n-3 Fatty Acids and Fish on Glucose and Lipid Metabolism in Subjects With Impaired Glucose Metabolism
- ClinicalTrials.gov ID
- NCT01768429
- Acronym / sponsor ID
- ALFAKALA
- Conditions
- Hyperglycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- University of Eastern FinlandUniversity, hospital or other
- Collaborators
- Kuopio University Hospital, VTT Technical Research Centre, Finland
- Study start
- Oct 2012
- Primary completion
- Jun 2014 (actual)
- First posted
- 15 Jan 2013 (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 aim of the project is to examine whether the sources of n-3 fatty acids and fish itself differ in their effects on glucose metabolism, lipid metabolism, blood pressure, and serum inflammatory markers. Lipidomic profiles and gene expression will be used for thorough assessment of the possible clinical changes. The study will compare the effects of alpha-linolenic acid containing vegetable oil, fatty fish, lean fish and control diet. The results of this project will help to identify the optimal source of n-3 fatty acids, and reveal the significance of the components of fish other than fatty acids. These data will be useful both nationally and internationally, since highly controlled dietary interventions utilizing new methodology are scarce.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Fatty fish | Experimental | Behavioral: Fatty fishFour fatty fish meals per week |
| Lean Fish | Experimental | Behavioral: Lean FishFour lean fish meals per week |
| Alpha-linolenic acid | Experimental | Behavioral: Alpha-linolenic acid10 g of alpha-linolenic acid daily from camelina sativa oil |
| Control diet | Experimental | Behavioral: ControlLimited fish and alpha-linolenic acid intake |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age 40-70 years
- BMI 25-32 kg/m2
- fasting plasma glucose 5.6-7.0 mmol/l
- 2 h plasma glucose in oral glucose tolerance test <=11 mmol/l
- fasting serum total cholesterol <=7 mmol/l
Key exclusion criteria (11 listed)
- any chronic disease or condition that hamper the ability to follow dietary intervention
- chronic liver, thyroid or kidney disease
- alcohol abuse
- diabetes
- recent weight loss
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 |
|---|---|---|
| Fatty fish | Behavioural | Fatty fish |
| Lean Fish | Behavioural | Lean Fish |
| Alpha-linolenic acid | Behavioural | Alpha-linolenic acid |
| Control | Behavioural | Control diet |
Primary outcome
Glucose metabolism assessed by oral glucose tolerance test and frequently sampled intravenous glucose tolerance test
Time frame: Baseline and 12 weeks
change in glucose metabolism
Serum lipid profile
Time frame: Baseline and at 12 weeks
Change in serum lipid profile
Blood pressure
Time frame: Baseline and 12 weeks
Change in blood pressure
Serum inflammatory markers
Time frame: baseline and 12 weeks
Change in serum inflammatory markers
Plasma and adipose tissue lipidomic profile
Time frame: Baseline and 12 weeks
Change in plasma and adipose tissue lipidomic profile
Plasma and urine metabonomics
Time frame: Baseline and 12 weeks
Change in plasma and urine metabonomics
Gene expression in adipose tissue and peripheral blood mononuclear cells
Time frame: Baseline and 12 weeks
Change in gene expression in adipose tissue and peripheral blood mononuclear cells
1 secondary outcome
Reverse cholesterol transport
Time frame: Baseline and 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 3 Dec 2014.
- Derived from this study: PubMed 32512364Meuronen T, Lankinen MA, Fauland A, Shimizu BI, de Mello VD, Laaksonen DE, Wheelock CE, Erkkila AT, Schwab US. Intake of Camelina Sativa Oil and Fatty Fish Alter the Plasma Lipid Mediator Profile in Subjects with Impaired Glucose Metabolism - A Randomized Controlled Trial. Prostaglandins Leukot Essent Fatty Acids. 2020 Aug;159:102143. doi: 10.1016/j.plefa.2020.102143. Epub 2020 May 30.
- Derived from this study: PubMed 30658192Manninen S, Lankinen M, Erkkila A, Nguyen SD, Ruuth M, de Mello V, Oorni K, Schwab U. The effect of intakes of fish and Camelina sativa oil on atherogenic and anti-atherogenic functions of LDL and HDL particles: A randomized controlled trial. Atherosclerosis. 2019 Feb;281:56-61. doi: 10.1016/j.atherosclerosis.2018.12.017. Epub 2018 Dec 23.
- Derived from this study: PubMed 30454883Manninen S, Lankinen M, de Mello V, Agren J, Laaksonen D, Schwab U, Erkkila A. The effect of camelina sativa oil and fish intakes on fatty acid compositions of blood lipid fractions. Nutr Metab Cardiovasc Dis. 2019 Jan;29(1):51-61. doi: 10.1016/j.numecd.2018.10.002. Epub 2018 Oct 11.
- Derived from this study: PubMed 29645359Manninen SM, Lankinen MA, de Mello VD, Laaksonen DE, Schwab US, Erkkila AT. Intake of Fatty Fish Alters the Size and the Concentration of Lipid Components of HDL Particles and Camelina Sativa Oil Decreases IDL Particle Concentration in Subjects with Impaired Glucose Metabolism. Mol Nutr Food Res. 2018 May;62(10):e1701042. doi: 10.1002/mnfr.201701042.
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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.
Arja Erkkilä, Adjunct Prof principal investigator
University of Eastern Finland
Ursula Schwab, Adjunct Prof principal investigator
University of Eastern Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fatty fish, Lean Fish and Alpha-linolenic acid in people with Hyperglycemia, run by University of Eastern Finland at 1 site in Finland.
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 7 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 3 Dec 2014. 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 Finland. 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.
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 metabolism assessed by oral glucose tolerance test and frequently sampled intravenous glucose tolerance test (time frame: Baseline and 12 weeks). The study lists 7 primary outcomes in all. 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 NCT01768429, which also lists 4 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 3 Dec 2014.