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

NCT05621083 | Completed

• 1 other identifier: REK sør-øst B 482316
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Healthy Volunteers; Postprandial TG response

Outcome Measures

Primary Outcomes (1)

• Fasting TG

  Baseline levels of circulating triglycerides

  up to 6 weeks

Secondary Outcomes (9)

• Postprandial TG

  up to 6 weeks

• 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

  up to 6 weeks

• Fasting plasma cytokines, acute phase proteins and soluble adhesion molecules

  up to 6 weeks

• Fasting whole genome Peripheral Blood Mononuclear Cells (PBMC) transcriptome (mRNA and miRNA)

  up to 6 weeks

• Fasting epigenome in PBMCs

  up to 6 weeks

Study Arms (2)

Fish oil (the omega-3 fatty acid supplement)

EXPERIMENTAL

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.

Dietary Supplement: Omega- 3

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

PLACEBO COMPARATOR

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.

Dietary Supplement: HOSO

Interventions

Omega- 3 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.

Fish oil (the omega-3 fatty acid supplement)

HOSO DIETARY_SUPPLEMENT

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

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

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oslo: lead
• Throne-Holst Foundation for Nutrition Research: collaborator
• Horizon 2020 - European Commission: collaborator
• GC Rieber VivoMega AS: collaborator

Study Sites (1)

University of Oslo

Oslo, Norway

Location

MeSH Terms

Interventions

Docosahexaenoic Acids

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The principal investigator will have access to the randomization code containing the order of the oils (starting with HOSO or starting with fish oil), which is generated by an external statistician. The PI will make sure that the identical boxes with capsules (both HOSO and fish oil) will be marked only with Identification (ID) number and period number (cross over 1 and 2). The participant, the care provider and the outcomes assessor will not know the randomization code before after the data of the primary outcome has been analyzed.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Nutrition, Principal Investigator, Professor

Model Details: Start with control oil (HOSO) or start with fish oil, and then change after 12 weeks of wash out.

Study Record Dates

• First Submitted: November 2, 2022
• First Posted: November 17, 2022
• Study Start: April 11, 2023
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: March 28, 2025

Record last verified: 2025-03

Locations

NO (1)