Effects of Cetoleic Acid on Atherosclerosis (Ketolinsyre's Effekt på Aterosklerose)

NCT06172335 | Recruiting

• 1 other identifier: 605236
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

In this Randomized Controlled Trial (RCT) we want to study the effect of an oil with high concentrations of cetoelic acid (C22:n1-11) (intervention) compared to supplements with a low concentration of cetoleic acid (control), but with equivalent content of EPA og DHA, on plasma levels of epa and dha as well as atherosclerotic markers, glucose, c-peptide and triglycerides in a patient group with a metabolically unfavorable phenotype. Our primary endpoints are changes in the concentration of EPA and DHA in plasma.

Conditions

Metabolic Syndrome

Keywords

Omega 3 fatty acids; Sustainability; Cetoleic acid; Very long monounsaturated fatty acid; Cardiovascular disease prevention; Antiinflammation

Outcome Measures

Primary Outcomes (1)

• EPA and DHA in plasma

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

  4 weeks intervention

Secondary Outcomes (6)

• Lipid profile

  4 weeks intervention

• Glucose

  4 weeks intervention

• Inflammatory markers

  4 weeks intervention

• Gene expression, metabolome and lipidome

  4 weeks intervention

• Resolvin

  4 weeks intervention

Study Arms (2)

Intervention (Cetoleic acid)

EXPERIMENTAL

6 x capsules intervention oil (oil = mix of fish oils, olive oil, high-oleic sunflower oil and rapeseed oil) with high content of cetoleic acid (1780 mg/day, estimated: 29,76%) every morning for 4 weeks.

Dietary Supplement: Cetoleic acid

Control oil

PLACEBO COMPARATOR

6 x capsules control oil (oil= mix of fish oils, olive oil, high-oleic sunflower oil and rapeseed oil) with low content of cetoleic acid (35 mg/day, estimated 0.58%) every morning for 4 weeks.

Dietary Supplement: Control oil

Interventions

Cetoleic acid DIETARY_SUPPLEMENT

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

Intervention (Cetoleic acid)

Control oil DIETARY_SUPPLEMENT

Mix of oils with low cetoleic acid content

Control oil

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Triglycerides \> 1.7 mmol/L
• Waist measurement \> 80 cm (women) and \> 94 cm (men)

You may not qualify if:

• Chronic disease (liver/kidney/metabolism)
• Ongoing active cancer treatment
• Excessive alcohol consumption (\>40g/day)
• Pregnant/breastfeeding or planned pregnancy during the intervention
• High intake of fish (\>3 weekly meals)
• Level of free thyroxine (T4) and triiodothyronine (T3) outside reference ranges.
• Hypertension (≥ 160/ 100 mmHg)
• Total cholesterol \> 7.8 mmol/L
• Blood donation during the intervention period
• Difficulty following the protocol
• Smoking or sniffing
• Regular use (\> 1 day/week) of anti-inflammatory drugs
• Regular use of omega-3 supplements/cod liver oil
• Drug use other than stable use of statins, hypertension drugs (Ca antagonists, diuretics and beta blockers).
• Hormonal treatment excluding stable use of thyroxine and birth control pills/contraceptive rod

Sponsors & Collaborators

• Oslo University Hospital: lead
• University of Oslo: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, Norway

RECRUITING

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

cetoleic acid

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Kirsten B. Holven, PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kirsten B. Holven, PhD

CONTACT

+4722851361; kirsten.holven@medisin.uio.no

Iselin S. Holen, MSc

CONTACT

+4722894882; ishole@ous-hf.no

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
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

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.

Study Record Dates

• First Submitted: October 2, 2023
• First Posted: December 15, 2023
• Study Start: January 3, 2024
• Primary Completion: December 30, 2024
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 16, 2025

Record last verified: 2025-01

Locations

NO (1)