Connexion
M'inscrire

Votre recherche

Filtres

Project précédent
Projet suivant

605236

Effects of cetoleic acid on atherosclerosis (ketolinsyre's effekt på aterosklerose)
Source : Importé depuis le centre

Référence clinicaltrials.gov: NCT06172335
Omega 3 fatty acids
Sustainability
Cetoleic acid
Very long monounsaturated fatty acid
Cardiovascular disease prevention
Antiinflammation
Source : Importé depuis le centre
Recrutement ouvert
Dernière modification : 2025/01/15
Type de recherche

Interventionnel


Population cible

Condition médicale (spécialité visée)

Donnée non disponible

Profil des participants

Sexe(s) des participants

ALL

Source : Importé depuis le centre

Critères de sélection

Critères d'inclusion

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

Source : Importé depuis le centre

Thérapie ou Intervention proposée

Cohortes
Nom Condition médicale Traitement État du recrutement
Intervention (Cetoleic acid) 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. Donnée non disponible
  • Inconnu
  • Control oil 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. Donnée non disponible
  • Inconnu
  • Intervention (Cetoleic acid)
    État du recrutement
    unknown
    Control oil
    État du recrutement
    unknown
    Données à jour depuis : 15 janvier 2025

    Description de l'étude

    Résumé de l'étude

    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.

    Source : Importé depuis le centre

    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).

    Source : Importé depuis le centre

    Sites

    Centres participants


    Dernière modification : 15 janvier 2025
    Données à jour depuis : 17 jan.
    Origine des données : clinicaltrials.gov
    Référence clinicaltrials.gov: NCT06172335