NCT04841044

Brief Summary

In this Randomized Controlled Trial (RCT) we want to study how supplements of cetoleic acid ( C22:n1-11) (intervention) affect the conversion of alpha-linolenic acid (ALA) to EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) in healthy subjects, compared to supplements with a low concentration of cetoleic acid (control). Our primary endpoints are changes in the concentration of EPA and DHA in plasma and red blood cells.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 12, 2021

Completed
15 days until next milestone

Study Start

First participant enrolled

April 27, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

October 4, 2021

Status Verified

September 1, 2021

Enrollment Period

1 year

First QC Date

April 8, 2021

Last Update Submit

September 27, 2021

Conditions

Healthy Diet

Keywords

Omega 3 fatty acidsSustainabilityCetoleic acidVery long monounsaturated fatty acidCardiovascular disease preventionAntiinflammation

Outcome Measures

Primary Outcomes (2)

  • EPA and DHA in plasma

    EPA and DHA concentration in plasma measured at baseline and and after 4 week intervention (and as a "control measurement" at the screening visit)

    4 weeks intervention

  • EPA and DHA in red blood cells

    EPA and DHA concentration and omega 3 index (EPA+DHA/total fatty acids) in red blood cells measured at baseline and and after 4 week intervention (and as a "control measurement" at the screening visit)

    4 weeks

Secondary Outcomes (9)

  • Lipid profile- Triglycerides

    4 weeks

  • Lipid profile- Cholesterol

    4 weeks

  • Lipid profile- Apolipoproteins

    4 weeks

  • Lipid profile- Lipoproteins

    4 weeks

  • Inflammatory markers

    4 weeks

  • +4 more secondary outcomes

Study Arms (2)

Intervention ( Cetoleic acid)

EXPERIMENTAL

6x mackerel oil (cetoleic acid: 16A%, estimated: 135 mg/g (FFA)) capsules every morning for 4 weeks (A%= area percent)

Dietary Supplement: Cetoleic acid

Control oil

PLACEBO COMPARATOR

6x capsules control oil (Control oil= mix of anchovy oil, olive oil, high-oleic sunflower oil, rapeseed oil (cetoleic acid: 0,7 A% estimated: 6 mg/g (FFA)) every morning for 4 weeks (A%= area percent)

Dietary Supplement: Control Oil

Interventions

Cetoleic acidDIETARY_SUPPLEMENT

Very long monounsaturated fatty acid ( C22:1n-11)

Intervention ( Cetoleic acid)
Control OilDIETARY_SUPPLEMENT

Control oil consisting of: mix of anchovy oil, olive oil, high-oleic sunflower oil and rapeseed oil

Control oil

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI 20-35kg/m2
  • opportunity to meet for 3 visits at the Department of Nutrition, University of Oslo, during the study period.

You may not qualify if:

  • Chronic disease (liver/kidney/metabolism)
  • Alcohol overconsumption (\>40g/day)
  • Diabetes and high fasting blood glucose
  • Pregnant/ breastfeeding or planning pregnancy during the study period
  • High fish intake (\>3 meals/week).
  • Blood donation during the study period
  • Difficulty following the study protocol.
  • Smoking/snuffing
  • Regularly use of anti-inflammatory drugs
  • Regularly use of omega-3 supplements /cod liver oil.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oslo

Oslo, 0316, Norway

Location

MeSH Terms

Interventions

cetoleic acid

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
All participant, the major investigator, study coordinator and the study staff are blinded for the randomizing. The capsules and capsule containers will only be identifiable by the ID (identifying) numbers on the containers. Allocation of participants to the specific intervention group is carried out by a statistician and one person not involved in conducting the study.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized double-blinded controlled trial (Randomized 1:1, control:intervention). Run-in period of 3 weeks where all participants receive the control capsules.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 8, 2021

First Posted

April 12, 2021

Study Start

April 27, 2021

Primary Completion

April 30, 2022

Study Completion

December 31, 2025

Last Updated

October 4, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Data will not be sheared as individual participant data, but the results will be shared on group levels. All participants information are treated deidentified

Locations

NO(1)