Omega-3 Fatty Acids on Fasting and Postprandial Triglycerides (TG) Response - a Pilot Study

Healthy Clinical Trial

— Omega 3-PT  

Official title:

Effects of Omega-3 Fatty Acids on Fasting and Postprandial TG Response in Healthy Subjects (Omega-3PT) - a Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05621083
• Other study ID #: REK sør-øst B 482316
• Status: Recruiting
• Phase: N/A
• Start date: April 11, 2023
• Est. completion date: December 2026

Study information

• Verified date: August 2023
• Source: University of Oslo
• Contact: Stine M Ulven, PhD
• Phone: +47 22840208
• Email: smulven[@]medisin.uio.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this project is to elucidate how repeated exposure with omega-3 fatty acid supplementation for 6 weeks affect mean and individual fasting lipids and inflammatory responses and postprandial TG after a high fat meal with butter (50 g fat) in healthy subjects.

Description:

The investigators aim to perform a randomized controlled crossover trial where each participant will act as his or her own control. Participants will be randomized to either start to receive fish oil (the omega-3 fatty acid supplement, dose of 2.3 g Eicosapentaenoic acid fatty acids (EPA) + Docosahexaenoic acid fatty acids (DHA) /day) for 6 weeks or a high-oleic sunflower oil (HOSO) containing no omega-3 fatty acids, as control followed by a wash-out period of minimum 12 weeks, before the treatment is changed for 6 weeks. Before and after each intervention period we will take fasting blood samples and collect spot morning urine. At home, the participant will perform a voluntary postprandial meal test with 61 g butter (containing 50 g fat), use DBS to collect fasting (0 h) 2, 4, 6, and 8 h blood samples after intake of the meal to measure TG which has been validated previously.

The investigators will use first part of the trial to define fasting and postprandial TG responders and non-responders. The investigators will also monitor at home the postprandial TG response to HOSO to see the participants' postprandial response to a control oil without omega-3 fatty acids. After a 12 week wash-out period, we will then repeat the fish oil intervention period once more for all in order to see if those we defined as responders continue to be defined in the same category in the repeated fish oil intervention (adaptive design). The investigators will collect exposure data, including dietary intake, physical activity, and clinical data such as BMI, body composition (such as fat mass, visceral fat, fat free mass), blood pressure, lipids and glucose and specific single nucleotide polymorphism (SNPs) to understand the impact of these factors on the individual postprandial TG response. In addition, the investigators will collect feces samples before taken before each meal test day for gut microbiota analysis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: December 2026
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

• Body mass index (BMI) between 18.5-30 kg/m2

• Fasting TG level at =0.9 mmol/L

• Max eating one portion of fatty fish per week.

• All subjects must be willing to take two capsules with either fish oil or HOSO.

• They all need to accept to avoid taking omega-3 supplementation.

• If they use omega-3 supplements, they should wait 12 weeks before starting the study.

Exclusion Criteria:

• Unable to give informed consent

• BMI <18.5 and >30 kg/m2

• Weight change of ± 5 % of body weight in the last three months

• TG <0.9 mmol/L and > 1.7 mmol/L

• C reactive protein (CRP) >10 mg/L

• Total cholesterol >6.9 mmol/L for subjects 30-49 years and >7.8 mmol/L for subjects =50 years old

• Blood pressure >160/100 mm Hg

• Comorbidities 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 lactating

• Having CVD/CHD or cancer past 1 year

• Allergic or intolerant to gluten, milk protein and/or lactose

• Use of medications affecting lipids and lipid metabolism, blood clotting or inflammation.

• 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 period

• Hormone treatment (stabile dose of contraception or thyroxin for the last three months excepted)

• Use of medications affecting lipids and lipid metabolism, blood clotting or inflammation. Stable dose (more than 3 months) of statin, estrogen or blood pressure medications during the trial is allowed.

• Blood donation two months prior to or during the study period

• Tobacco smoking and snuff

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Omega- 3
In the fish oil supplement period, the participants will receive concentrated fish oil which is equal to in total 2.3 g EPA+DHA per day during 6 weeks.
• HOSO
In the HOSO period, the participants will receive similar amount of HOSO per day during 6 weeks.

Locations

Country	Name	City	State
Norway	University of Oslo	Oslo

Sponsors (4)

Lead Sponsor	Collaborator
University of Oslo	GC Rieber VivoMega AS, Horizon 2020 - European Commission, Throne-Holst Foundation for Nutrition Research

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting TG	Baseline levels of circulating triglycerides	up to 6 weeks
Secondary	Postprandial TG	At home, the participant will perform a voluntary postprandial meal test with 61 g butter (containing 50 g fat), use DBS to collect fasting(0 h) 2, 4, 6, and 8 h blood samples after intake of the meal	up to 6 weeks
Secondary	Fasting cholesterol, free fatty acids (FFA), LDL cholesterol, high-density lipoprotein (HDL) cholesterol, Apo A1, Apo B, Apo B-48 and Apo C-III, and lipoprotein subclasses, glucose and insulin	measure fasting levels -compare fasting levels before and after intake of omega-3 or HOSO	up to 6 weeks
Secondary	Fasting plasma cytokines, acute phase proteins and soluble adhesion molecules	measure fasting levels of all inflammatory markers before and after intake of omega-3 or HOSO	up to 6 weeks
Secondary	Fasting whole genome Peripheral Blood Mononuclear Cells (PBMC) transcriptome (mRNA and miRNA)	fasting levels before and after intake of omega-3 or HOSO	up to 6 weeks
Secondary	Fasting epigenome in PBMCs	fasting levels before and after intake of omega-3 or HOSO	up to 6 weeks
Secondary	Fasting targeted and non-targeted metabolic profiling in plasma	fasting levels before and after intake of omega-3 or HOSO	up to 6 weeks
Secondary	Targeted and untargeted metabolomics of spot urine to measure dietary intake biomarkers	Measure food intake metabolites in spot urine	up to 6 weeks
Secondary	SNPs in whole blood	measure specific SNPs related to omega-3 intake and TG response	Measured once at baseline
Secondary	Composition of the gut microbiome (both metabolites and bacteria composition)	measure metabolites in blood and feces and bacteria composition in feces	up to 6 weeks