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

NCT ID: NCT05621083

Last Updated: 2025-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-11
• Study Completion Date: 2025-01-31

Brief 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.

Detailed 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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Fish oil (the omega-3 fatty acid supplement)

Participants will be randomized to either start to receive fish oil (the omega-3 fatty acid supplement) for 6 weeks. Followed by a wash-out period of a minimum of 12 weeks before the treatment is changed.

Once the classical Randomized Controlled Trial (RCT) has finished, all the participants will repeat the fish oil intervention period (adaptive design) to determine if those the investigators defined as responders continue to be defined in the same category.

Group Type: EXPERIMENTAL

Omega- 3

Intervention Type: DIETARY_SUPPLEMENT

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.

High-oleic sunflower oil (HOSO) containing no omega-3 fatty acids

Participants will be randomized to either start to receive high-oleic sunflower oil (HOSO) for 6 weeks. Followed by a wash-out period of minimum 12 weeks, before the treatment is changed.

Group Type: PLACEBO_COMPARATOR

HOSO

Intervention Type: DIETARY_SUPPLEMENT

In the HOSO period, the participants will receive similar amount of HOSO per day during 6 weeks.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

HOSO

In the HOSO period, the participants will receive similar amount of HOSO per day during 6 weeks.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Throne-Holst Foundation for Nutrition Research

UNKNOWN

Sponsor Role: collaborator

Horizon 2020 - European Commission

OTHER

Sponsor Role: collaborator

GC Rieber VivoMega AS

UNKNOWN

Sponsor Role: collaborator

University of Oslo

OTHER

Sponsor Role: lead

Responsible Party

Stine Marie Ulven

Head of Department of Nutrition, Principal Investigator, Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Oslo

Oslo, , Norway

Countries

Norway

Other Identifiers

REK sør-øst B 482316

Identifier Type: -

Identifier Source: org_study_id