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NCT05621083
Omega-3 Fatty Acids on Personal Post-Prandial Triglycerides (TG) Response
Conditions: Healthy, Overweight
Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 52
Sponsor: University of Oslo
Location: Norway
Summary
The aim of this project is to elucidate how omega-3 fatty acids for 6 weeks affect mean and individual postprandial TG responses after a high fat meal with butter (50 g fat) in healthy overweight subjects.
Eligibility Criteria
Inclusion Criteria:Body mass index (BMI) between 25-30 kg/m2Fasting TG level at ≥1.0 mmol/LMax eating one portion of fatty fish per week.All subjects must be willing to take two capsules with either fish oil or HOSO.All subjects must be able to eat three slices of bread with butter and jam as breakfast (x6; each visit)They all need to accept to avoid taking omega-3 supplementation or other dietary supplements during the study.If they use omega-3 supplements, they should wait 12 weeks before starting the study.Exclusion Criteria:Unable to give informed consentBMI <25 and >30 kg/m2Weight change of ± 5 % of body weight in the last three monthsTG <1.0 mmol/L and > 1.7 mmol/LC reactive protein (CRP) >10 mg/LTotal cholesterol >6.1 mmol/L for subjects 18-29 years, >6.9 mmol/L for subjects 30-49 years and >7.8 mmol/L for subjects ≥50 years oldBlood pressure >160/100 mm HgComorbidities including diabetes type I and II (blood glucose ≥7 mmol/L fasting), Cardiovascular diseases(CVD)/Coronary heart disease (CHD), haemophilia, anaemia (hemoglobin <120 gram/L), gastro intestinal disease, hyperthyroidism (TSH >4 Milliunits per litre (mU/L)) or inflammatory diseases such as rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), polymyalgia and other connective tissue diseases.Pregnant or lactatingHaving CVD/CHD or cancer past 1 yearAllergic or intolerant to gluten, milk protein and/or lactoseUse of medications affecting lipids and lipid metabolism, blood clotting or inflammation.
Stable dose of blood pressure medications during the trial is allowed.Unwilling to separate any use of omega-3 fatty acid supplements and other supplements during the study, and fish intake more than one portion per week, 12 weeks prior to and during the study periodHormone treatment (stabile dose of contraception or thyroxin for the last three months excepted)Blood donation two months prior to or during the study periodTobacco smoking and snuff
Source: ClinicalTrials.gov (NCT05621083). StuddyBuddy aggregates publicly available trial information.