Omega 3-PT: Omega-3 Fatty Acids on Personal Post-Prandial Triglycerides (TG) Response

Sponsor

University of Oslo (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05621083

Collaborator

Throne-Holst Foundation for Nutrition Research (Other), Horizon 2020 - European Commission (Other), GC Rieber VivoMega AS (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Overweight	Dietary Supplement: Omega- 3 Dietary Supplement: HOSO	N/A

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 the investigators will take fasting blood samples and collect spot morning urine and perform a postprandial meal test with 61 g butter (containing 50 g fat), and take blood samples 2, 4, 6, and 8 hours after intake of the meal. The investigators will use first part of the trial to define postprandial TG responders and non-responders. The investigators will also monitor 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, the investigators will then repeat the fish oil intervention period once more for all in order to see if those the investigators 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 (measured continuously) 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

52 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

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

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Prevention

Official Title:

Effects of Omega-3 Fatty Acids on Personal Post-Prandial Triglycerides Response in Healthy Overweight Subjects

Anticipated Study Start Date :

Nov 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Dec 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Dietary Supplement: Omega- 3 In each visit, the investigators will perform a postprandial meal test (set breakfast: Butter (61 g) with jam and three slices of white bread) 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.
Placebo Comparator: 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.	Dietary Supplement: HOSO In each visit, the investigators will perform a postprandial meal test (set breakfast: Butter (61 g) with jam and three slices of white bread) In the HOSO period, the participants will receive similar amount of HOSO per day during 6 weeks.

Arm

Intervention/Treatment

Experimental: 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.

Dietary Supplement: Omega- 3

In each visit, the investigators will perform a postprandial meal test (set breakfast: Butter (61 g) with jam and three slices of white bread) 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.

Placebo Comparator: 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.

Dietary Supplement: HOSO

In each visit, the investigators will perform a postprandial meal test (set breakfast: Butter (61 g) with jam and three slices of white bread) In the HOSO period, the participants will receive similar amount of HOSO per day during 6 weeks.

Outcome Measures

Primary Outcome Measures

Postprandial TG [up to 6 weeks]
measure iAUC of TG values postprandially (0,2,4,6,8,hours)-compare Incremental Area Under the Curve (iAUC) before and after intake of omega-3 or HOSO

Secondary Outcome Measures

Fasting TG [up to 6 weeks]
Baseline levels of circulating triglycerides
Fasting and postprandial total 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 (measured continuously) and insulin [up to 6 weeks]
measure fasting levels and iAUC of all lipids and postprandially (0,2,4,6,8,hours)-compare fasting levels and iAUC before and after intake of omega-3 or HOSO
Fasting and postprandial plasma cytokines, acute phase proteins and soluble adhesion molecules [up to 6 weeks]
measure fasting levels and iAUC of all inflammatory markers and postprandially (0,2,4,6,8,hours)-compare fasting levels and iAUC before and after intake of omega-3 or HOSO
Fasting and postprandial whole genome Peripheral Blood Mononuclear Cells (PBMC) transcriptome (mRNA and miRNA) [up to 6 weeks]
compare fasting levels before and after intervention and fasting levels with 4 hours after intake of meal
Fasting and postprandial epigenome in PBMCs [up to 6 weeks]
compare fasting levels before and after intervention and fasting levels with 4 hours after intake of meal
Fasting and postprandial targeted and non-targeted metabolic profiling in plasma [up to 6 weeks]
measure fasting levels and iAUC of metabolites and postprandially (0,2,4,6,8,hours)-compare fasting levels and iAUC before and after intake of omega-3 or HOSO
Targeted and untargeted metabolomics of spot urine to measure dietary intake biomarkers [up to 6 weeks]
Measure food intake metabolites in spot urine
SNPs in whole blood [Measured once at baseline]
measure specific SNPs related to omega-3 intake and TG response
Composition of the gut microbiome (both metabolites and bacteria composition) [up to 6 weeks]
measure metabolites in blood and feces and bacteria composition in feces

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Body mass index (BMI) between 25-30 kg/m2
Fasting TG level at ≥1.0 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.
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 consent
BMI <25 and >30 kg/m2
Weight change of ± 5 % of body weight in the last three months
TG <1.0 mmol/L and > 1.7 mmol/L
C reactive protein (CRP) >10 mg/L
Total 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 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. 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 period
Hormone treatment (stabile dose of contraception or thyroxin for the last three months excepted)
Blood donation two months prior to or during the study period
Tobacco smoking and snuff

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Oslo	Oslo		Norway

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Stine Marie Ulven, Head of Department of Nutrition, Principal Investigator, Professor, University of Oslo

ClinicalTrials.gov Identifier:

NCT05621083

Other Study ID Numbers:

REK sør-øst B 482316

First Posted:

Nov 17, 2022

Last Update Posted:

Nov 17, 2022

Last Verified:

Nov 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Stine Marie Ulven, Head of Department of Nutrition, Principal Investigator, Professor, University of Oslo

Healthy Volunteers

Postprandial TG response

Additional relevant MeSH terms:

Overweight

Study Results

No Results Posted as of Nov 17, 2022