Clinical trial NCT06364163: Effect of Herring Oil Concentrate on LDL Cholesterol Concentration in Adults
Official title: A Study on the Effect of Consuming a Herring Oil Concentrate on LDL Cholesterol Concentration in Adults With Overweight or Obesity
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: High Cholesterol
Keywords: Cholesterol
Cetoleic acid
Lead sponsor: University of Bergen
Sponsor class: OTHER
Collaborators: name: The Norwegian Seafood Research Fund
First posted: 2024-04-15
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: High cholesterol concentration is a major risk factor for cardiovascular disease (CVD), and consumption of fish has been associated with a lower CVD risk in several studies. The beneficial health effects of consuming fish have traditionally been ascribed to the long-chain PUFA (LC-PUFA) EPA (C20:5n-3) and DHA (C22:6n-3), although consumption of fish oils or concentrates with high EPA and DHA contents does not affect the cholesterol concentration in humans and lowers the cholesterol concentration in rats and mice only when given in very high doses. Fish oils contain a plethora of fatty acids besides EPA and DHA, and in recent years, increased focus has been on the long-chain MUFA (LC-MUFA) cetoleic acid (C22:1n-11). Cetoleic acid is found in high amounts in oils from certain fish species such as herring, which has relatively low contents of both EPA and DHA. The investigators have recently summarised and meta-analysed the available literature that investigates the effects of diets containing fish oils or fish oil concentrates that have a high content of cetoleic acid but low or no content of EPA and DHA on cholesterol concentration in rodents, showing that cetoleic acid-rich fish oils and concentrates prevent high cholesterol concentration.


Eligibility criteria: Inclusion Criteria:

* BMI over 27 kg/m2
* Stable body weight last 3 months

Exclusion Criteria:

* Allergies towards fish, milk, egg, gluten
* Tobacco use (cigarettes or snus)
* Diseases affecting the heart, intestinal function, kidney function or insulin secretion
* Use of medications targeting cholesterol -or glucose metabolism, hypertension
* Use of dietary supplements
* Pregnant or breastfeeding
* Following a strict diet
* Had bariatric surgery
* Recent or planned surgical procedures
* High intake of fish/seafood

Primary outcomes:
measure: Serum concentration of LDL-cholesterol
timeFrame: 8 weeks
Secondary outcomes:
measure: Serum concentration of HDL-cholesterol
timeFrame: 8 weeks
measure: Serum concentration of total cholesterol
timeFrame: 8 weeks
measure: Serum concentrations of apolipoproteins
timeFrame: 8 weeks
measure: Serum concentrations of amino acids metabolites
timeFrame: 8 weeks
measure: Serum concentration of one-carbon pathway metabolites
timeFrame: 8 weeks
measure: Fatty acid composition in leukocytes
timeFrame: 8 weeks
measure: Serum concentration of glucose
timeFrame: 8 weeks
measure: Serum concentration of insulin
timeFrame: 8 weeks
measure: Urine concentrations of cystatin C
timeFrame: 8 weeks
measure: Urine concentrations of T cell immunoglobulin mucin-1 (TIM-1)
timeFrame: 8 weeks
measure: Body composition
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: University of Bergen
Study officials:
References: