HyperlipidemiasLeSIPNCT01708681
Lean Seafood Intake and Postprandial Metabolism
A study testing Lean seafood and Meat, egg, milk in people with Hyperlipidemias and Nutritional and Metabolic Diseases, run by National Institute of Nutrition and Seafood Research, Norway at 1 site in Norway.
Trial summary
Despite numerous studies of meal components in humans, little is still known about how different meals influence on metabolism. The purpose of this study is to a gain knowledge of how a balanced test meal with either lean seafood (example:cod) or meat as the main protein source will: 1. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemias, Nutritional and Metabolic Diseases, Nutrition Disorders
- What is being tested?
- Lean seafood and Meat, egg, milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2012to Sep 2015
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-65 years of age
- Caucasian
Who cannot join
- Smoking
- Diabetes
- Hysterectomy
- Abnormal bleeding last 6 months
- Use of medication that affects lipid and glucose metabolism
- Large (>10%) alteration in body-weight the last 6 months
- Chronic, metabolic or acute disease or major surgery within last 3 months
- Dietary incompatibility with calcium supplementation and/ or seafood consumption (allergy, intolerance, dislike)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ability of a Lean Seafood Diet to Modulate Postprandial Metabolism in Human-beings - a Controlled Intervention Study With Cross-over Design
Despite numerous studies of meal components in humans, little is still known about how different meals influence on metabolism. The purpose of this study is to a gain knowledge of how a balanced test meal with either lean seafood (example:cod) or meat as the main protein source will:
- affect the postprandial metabolism acutely (test-meal at beginning of the study)
- affect the postprandial metabolism after 4 weeks controlled intervention (test meal at end of intervention period)
- affect gut microbiota composition
- Conditions
- Hyperlipidemias, Nutritional and Metabolic Diseases, Nutrition Disorders, Metabolic Diseases, Glucose Metabolism Disorders
- Being tested
- Lean seafood, Meat, egg, milk
- Keywords
- Seafood, Meat, Egg, Milk, Postprandial lipid metabolism, Postprandial glucose metabolism, Triglycerides, Cholesterol, Postprandial incretins, Postprandial hormones
- Medical subject headings
- Hyperlipidemias, Nutritional and Metabolic Diseases, Nutrition Disorders, Metabolic Diseases, Glucose Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lean seafoodDietary supplement
Meat, egg, milkDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Lean seafood | Experimental | Cross-over design, half of the subject will receive lean seafood in study period I and the other half in study period II Receives: Dietary Supplement: Lean seafood; Dietary Supplement: Meat, egg, milk |
| Meat, egg, milk | Active comparator | Cross-over design, half of the subject will receive meat, egg, milk in study period I and the other half in study period II Receives: Dietary Supplement: Lean seafood; Dietary Supplement: Meat, egg, milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial lipid measurement
Measured: Change from baseline at 4 weeks
Secondary outcomes (1)
Postprandial glucose measurement
Measured: Change from baseline at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionMay 2013
- Study completionSep 2015
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 HyperlipidemiasStudies 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Nutrition and Seafood Research, Norway
- Sponsor type
- Other government
- Collaborators
- The Research Council of Norway
- Responsible party
- Sponsor
- Investigators
- Bjørn Liaset, Dr, Principal investigator, NIFES
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01708681
- Sponsor's protocol ID
- NIFES-001
- Other IDs
- 2012/1084/REK vest
- Acronym
- LeSIP
- Status last verified
- Oct 2015
- First submitted
- 11 Oct 2012
- Last updated
- 6 Oct 2015
- Results posted
- No
Publications
Aadland EK, Graff IE, Lavigne C, Eng O, Paquette M, Holthe A, Mellgren G, Madsen L, Jacques H, Liaset B. Lean Seafood Intake Reduces Postprandial C-peptide and Lactate Concentrations in Healthy Adults in a Randomized Controlled Trial with a Crossover Design. J Nutr. 2016 May;146(5):1027-34. doi: 10.3945/jn.115.229278. Epub 2016 Apr 20.
PubMed 27099232Aadland EK, Lavigne C, Graff IE, Eng O, Paquette M, Holthe A, Mellgren G, Jacques H, Liaset B. Lean-seafood intake reduces cardiovascular lipid risk factors in healthy subjects: results from a randomized controlled trial with a crossover design. Am J Clin Nutr. 2015 Sep;102(3):582-92. doi: 10.3945/ajcn.115.112086. Epub 2015 Jul 29.
PubMed 26224298
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ability of a Lean Seafood Diet to Modulate Postprandial Metabolism in Human-beings - a Controlled Intervention Study With Cross-over Design
- ClinicalTrials.gov ID
- NCT01708681
- Acronym / sponsor ID
- LeSIP / NIFES-001
- Conditions
- Hyperlipidemias, Nutritional and Metabolic Diseases, Nutrition Disorders, Metabolic Diseases, Glucose Metabolism Disorders
- Keywords
- Seafood, Meat, Egg, Milk, Postprandial lipid metabolism, Postprandial glucose metabolism, Triglycerides, Cholesterol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- National Institute of Nutrition and Seafood Research, NorwayOther government
- Collaborators
- The Research Council of Norway
- Study start
- Oct 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 17 Oct 2012 (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.
Despite numerous studies of meal components in humans, little is still known about how different meals influence on metabolism. The purpose of this study is to a gain knowledge of how a balanced test meal with either lean seafood (example:cod) or meat as the main protein source will:
- affect the postprandial metabolism acutely (test-meal at beginning of the study)
- affect the postprandial metabolism after 4 weeks controlled intervention (test meal at end of intervention period)
- affect gut microbiota composition
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lean seafood | Experimental | Dietary Supplement: Lean seafood, Dietary Supplement: Meat, egg, milkCross-over design, half of the subject will receive lean seafood in study period I and the other half in study period II |
| Meat, egg, milk | Active comparator | Dietary Supplement: Lean seafood, Dietary Supplement: Meat, egg, milkCross-over design, half of the subject will receive meat, egg, milk in study period I and the other half in study period II |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18-65 years of age
- Caucasian
Key exclusion criteria (8 listed)
- Smoking
- Diabetes
- Hysterectomy
- Abnormal bleeding last 6 months
- Use of medication that affects lipid and glucose metabolism
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 |
|---|---|---|
| Lean seafood | Dietary supplement | Lean seafood, Meat, egg, milk |
| Meat, egg, milk | Dietary supplement | Lean seafood, Meat, egg, milk |
Primary outcome
Postprandial lipid measurement
Time frame: Change from baseline at 4 weeks
1 secondary outcome
Postprandial glucose measurement
Time frame: Change from baseline at 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 6 Oct 2015.
- Derived from this study: PubMed 27099232Aadland EK, Graff IE, Lavigne C, Eng O, Paquette M, Holthe A, Mellgren G, Madsen L, Jacques H, Liaset B. Lean Seafood Intake Reduces Postprandial C-peptide and Lactate Concentrations in Healthy Adults in a Randomized Controlled Trial with a Crossover Design. J Nutr. 2016 May;146(5):1027-34. doi: 10.3945/jn.115.229278. Epub 2016 Apr 20.
- Derived from this study: PubMed 26224298Aadland EK, Lavigne C, Graff IE, Eng O, Paquette M, Holthe A, Mellgren G, Jacques H, Liaset B. Lean-seafood intake reduces cardiovascular lipid risk factors in healthy subjects: results from a randomized controlled trial with a crossover design. Am J Clin Nutr. 2015 Sep;102(3):582-92. doi: 10.3945/ajcn.115.112086. Epub 2015 Jul 29.
- Related InfoLink provided by the sponsor.
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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.
Bjørn Liaset, Dr principal investigator
NIFES
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lean seafood and Meat, egg, milk in people with Hyperlipidemias and Nutritional and Metabolic Diseases, run by National Institute of Nutrition and Seafood Research, Norway at 1 site 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 8 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 6 Oct 2015. 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 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. 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?
Postprandial lipid measurement (time frame: Change from baseline at 4 weeks). 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 NCT01708681, 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 6 Oct 2015.