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

Metabolic Syndrome Clinical Trial

Official title:

Effects of Ketolic Acid on Atherosclerosis Markers in High-risk Patients With Metabolic Syndrome (Effekt av Ketolinsyre på aterosklerosemarkører i høyrisikopasienter Med Metabolsk Syndrom)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06172335
• Other study ID #: 605236
• Status: Recruiting
• Phase: N/A
• Start date: January 3, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: January 2024
• Source: Oslo University Hospital
• Contact: Kirsten B. Holven, PhD
• Phone: +4722851361
• Email: kirsten.holven[@]medisin.uio.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a randomized double-blinded controlled trial (randomized 1:1). Study population: men and women 20-70 years with a metabolically unfavorable phenotype defined as: triglycerides > 1.7 mmol/L and waist measurement > 80 cm (women) and > 94 cm (men).

Study design:

• 3 weeks run-in-period where all participants consume control capsules every morning.

• Randomization intervention: control (1:1). All participants consume their capsules (control or intervention) for 4 weeks.

The intervention oil is consists of an oil high in cetoleic acid and the control oil is low in cetoleic acid. Both the intervention oil and the control oil are a mix of different oils; fish oils, olive oil, "high-oleic sunflower oil" and rapeseed oil so that the content of EPA, DHA and ALA is similar in the two oils.

Power calculation and sample size:

It was expected a difference of 15% in n-3 between the groups after the intervention (Østbye et al. 2019, doi:10.1017/S0007114519001478).

The level of significance was set to 5% (two-sided) and the power to 80%. A total of thirty-eight subjects were required to participate in the study, but a high dropout rate was expected (20%) and it was considered necessary to include a total of seventy (n=70) subjects (thirty-five per arm).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 31, 2027
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• Triglycerides > 1.7 mmol/L

• Waist measurement > 80 cm (women) and > 94 cm (men)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Atherosclerosis
• Metabolic Syndrome
• Syndrome

Intervention

Dietary Supplement:
• Cetoleic acid
Very long monounsaturated fatty acid (C22:1n-11)
• Control oil
Mix of oils with low cetoleic acid content

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Lipid profile	Plasma levels of triglycerides, total cholesterol, LDL cholesterol, HDL cholesterol, apolipoproteins (apoB and apoA), and Lp(a)	4 weeks intervention
Secondary	Glucose	Serum levels of glucose	4 weeks intervention
Secondary	Inflammatory markers	The concentration of circulating levels of inflammatory markers	4 weeks intervention
Secondary	Gene expression, metabolome and lipidome	Changes in PBMC (peripheral blood mononuclear cell) gene expression profile. Changes in plasma metabolome and lipidome profile. Changes in PBMC epitranscriptome, as a regulator of the gene expression profile	4 weeks intervention
Secondary	Resolvin	Blood levels of resolvin (omega- 3 derivates) concentration	4 weeks intervention
Secondary	C-peptid	serum levels of C-peptid	4 weeks intervention