Dietary PreventionNoMaNCT01679496
Fat Quality on Blood Lipids and Immune Response
A study testing Food items in people with Dietary Prevention, run by University of Oslo at 1 site in Norway.
Trial summary
The purpose of this study is to investigate blood LDL-cholesterol and level of inflammatory markers after intake of food items with different fatty acid composition. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Dietary Prevention
- What is being tested?
- Food items
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteNorway
- Study dates
- Jun 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 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hsCRP < 10 mg/L
- total cholesterol 5-7.8 mmol/l(50-70 y)
- total cholesterol 5.0-6.9 mmol/l (30-49 y)
- total cholesterol 5.0-6.1 mmol/l (25-29 y)
- LDL-cholesterol at or above 3.5 mmol/l
- triglycerides at or lower 2.6 mmol/l
- BMI 20-35
- Stable bodyweight last 3 months.
Who cannot join
- Chronic diseases
- fasting glucose > 6.0 mmol/l
- increased ASAT and ALAT
- medications affecting lipidmetabolism and inflammation
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate blood LDL-cholesterol and level of inflammatory markers after intake of food items with different fatty acid composition.
- Conditions
- Dietary Prevention
- Being tested
- Food items
- Keywords
- LDL-cholesterol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food itemsOther
Food items with different fatty acid composition
| Study group | Role | What they receive |
|---|---|---|
| Food items | Experimental | Food items low in saturated fat and high in polyunsaturated fat Receives: Other: Food items |
| Control food items | Placebo comparator | Food items containing saturated fat and polyunsaturated fat according to a traditional Norwegian diet Receives: Other: Food items |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in LDL-cholesterol
Change in LDL-cholesterol when compared to control diet
Measured: Change from baseline after 8 weeks
Change in total cholesterol
Change in total cholesterol when compared to control diet
Measured: Change from baseline after 8 weeks
Secondary outcomes (6)
Inflammatory markers in circulation and at gene expression level in PBMC
Measured: Inflammatory markers are measured at baseline and after 8 weeks intervention in circulation and at gene expression level in PBMC
Markers of lipid metabolism at gene expression level in PBMC
Measured: Markers of lipid metabolism at gene expression level in PBMC is measured at baseline and after 8 weeks of intervention
Appetite hormones
Measured: Appetite hormones is measured at baseline and after 8 weeks of intervention
Gut peptides
Measured: Gut peptides are measured at baseline and after 8 weeks of intervention
Metabolites
Targeted and untargeted metabolomics will be measured
Measured: Metabolites are measured at baseline and after 8 weeks of intervention
Whole genome gene expression
Microarray
Measured: whole genome gene expression profiles are measured at baseline and after 8 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2014
- Study completionJun 2014
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 Dietary PreventionStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo Metropolitan University, Mills DA
- Responsible party
- Principal investigator, Stine Marie Ulven, University of Oslo
- Investigators
- Stine Ulven, PhD, Principal investigator, University of OsloKirsten B Holven, PhD, Principal investigator, Department of Nutrition, Institute for Basic Medical Sciences, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01679496
- Sponsor's protocol ID
- REK 2011/1951
- Acronym
- NoMa
- Status last verified
- Aug 2021
- First submitted
- 24 Aug 2012
- Last updated
- 20 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Pigsborg K, Gurdeniz G, Rangel-Huerta OD, Holven KB, Dragsted LO, Ulven SM. Effects of changing from a diet with saturated fat to a diet with n-6 polyunsaturated fat on the serum metabolome in relation to cardiovascular disease risk factors. Eur J Nutr. 2022 Jun;61(4):2079-2089. doi: 10.1007/s00394-021-02796-6. Epub 2022 Jan 9.
PubMed 34999928Ulven SM, Christensen JJ, Nygard O, Svardal A, Leder L, Ottestad I, Lysne V, Laupsa-Borge J, Ueland PM, Midttun O, Meyer K, McCann A, Andersen LF, Holven KB. Using metabolic profiling and gene expression analyses to explore molecular effects of replacing saturated fat with polyunsaturated fat-a randomized controlled dietary intervention study. Am J Clin Nutr. 2019 May 1;109(5):1239-1250. doi: 10.1093/ajcn/nqy356.
PubMed 31051508
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fat Quality on Blood Lipids and Immune Response
- ClinicalTrials.gov ID
- NCT01679496
- Acronym / sponsor ID
- NoMa / REK 2011/1951
- Conditions
- Dietary Prevention
- Keywords
- LDL-cholesterol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- Oslo Metropolitan University, Mills DA
- Study start
- Jun 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 6 Sep 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.
The purpose of this study is to investigate blood LDL-cholesterol and level of inflammatory markers after intake of food items with different fatty acid composition.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Food items | Experimental | Other: Food itemsFood items low in saturated fat and high in polyunsaturated fat |
| Control food items | Placebo comparator | Other: Food itemsFood items containing saturated fat and polyunsaturated fat according to a traditional Norwegian diet |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- hsCRP < 10 mg/L
- total cholesterol 5-7.8 mmol/l(50-70 y)
- total cholesterol 5.0-6.9 mmol/l (30-49 y)
- total cholesterol 5.0-6.1 mmol/l (25-29 y)
- LDL-cholesterol at or above 3.5 mmol/l
Key exclusion criteria (4 listed)
- Chronic diseases
- fasting glucose > 6.0 mmol/l
- increased ASAT and ALAT
- medications affecting lipidmetabolism and inflammation
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 |
|---|---|---|
| Food itemsFood items with different fatty acid composition | Other | Control food items, Food items |
Primary outcome
Change in LDL-cholesterol
Time frame: Change from baseline after 8 weeks
Change in LDL-cholesterol when compared to control diet
Change in total cholesterol
Time frame: Change from baseline after 8 weeks
Change in total cholesterol when compared to control diet
6 secondary outcomes
Inflammatory markers in circulation and at gene expression level in PBMC
Time frame: Inflammatory markers are measured at baseline and after 8 weeks intervention in circulation and at gene expression level in PBMC
Markers of lipid metabolism at gene expression level in PBMC
Time frame: Markers of lipid metabolism at gene expression level in PBMC is measured at baseline and after 8 weeks of intervention
Appetite hormones
Time frame: Appetite hormones is measured at baseline and after 8 weeks of intervention
Gut peptides
Time frame: Gut peptides are measured at baseline and after 8 weeks of intervention
Metabolites
Time frame: Metabolites are measured at baseline and after 8 weeks of intervention
Whole genome gene expression
Time frame: whole genome gene expression profiles are measured at baseline and after 8 weeks of intervention
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 20 Aug 2021.
- Derived from this study: PubMed 34999928Pigsborg K, Gurdeniz G, Rangel-Huerta OD, Holven KB, Dragsted LO, Ulven SM. Effects of changing from a diet with saturated fat to a diet with n-6 polyunsaturated fat on the serum metabolome in relation to cardiovascular disease risk factors. Eur J Nutr. 2022 Jun;61(4):2079-2089. doi: 10.1007/s00394-021-02796-6. Epub 2022 Jan 9.
- Derived from this study: PubMed 31051508Ulven SM, Christensen JJ, Nygard O, Svardal A, Leder L, Ottestad I, Lysne V, Laupsa-Borge J, Ueland PM, Midttun O, Meyer K, McCann A, Andersen LF, Holven KB. Using metabolic profiling and gene expression analyses to explore molecular effects of replacing saturated fat with polyunsaturated fat-a randomized controlled dietary intervention study. Am J Clin Nutr. 2019 May 1;109(5):1239-1250. doi: 10.1093/ajcn/nqy356.
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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.
Stine Ulven, PhD principal investigator
University of Oslo
Kirsten B Holven, PhD principal investigator
Department of Nutrition, Institute for Basic Medical Sciences, University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food items in people with Dietary Prevention, run by University of Oslo 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 8 inclusion and 4 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 20 Aug 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 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?
Change in LDL-cholesterol (time frame: Change from baseline after 8 weeks). The study lists 2 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 NCT01679496, 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 20 Aug 2021.