MedPath

Effect of Herring Oil Concentrate on LDL Cholesterol Concentration in Adults

Not Applicable
Active, not recruiting
Conditions
High Cholesterol
Interventions
Dietary Supplement: Herring oil concentrate
Dietary Supplement: Control
Registration Number
NCT06364163
Lead Sponsor
University of Bergen
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
80
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Herring oil concentrateHerring oil concentrateDietary supplement: herring oil concentrate in capsules, 4 g oil daily for 8 weeks
Control oilControlDietary supplement: control oil in capsules, 4 g oil daily for 8 weeks
Primary Outcome Measures
NameTimeMethod
Serum concentration of LDL-cholesterol8 weeks

LDL-cholesterol will be measured in fasting serum samples

Secondary Outcome Measures
NameTimeMethod
Serum concentration of glucose8 weeks

Glucose will be measured in serum sampled in fasting condition

Serum concentration of insulin8 weeks

Insulin will be measured in serum sampled in fasting condition

Urine concentrations of T cell immunoglobulin mucin-1 (TIM-1)8 weeks

T cell immunoglobulin mucin-1 (TIM-1) will be analysed in morning urine as a marker of kidney function

Fatty acid composition in leukocytes8 weeks

Leukocytes will be isolated from fasting serum before quantification of fatty acids

Serum concentration of HDL-cholesterol8 weeks

HDL-cholesterol will be measured in fasting serum samples

Serum concentration of total cholesterol8 weeks

Total cholesterol will be measured in fasting serum samples

Serum concentrations of amino acids metabolites8 weeks

Metabolites of amino acids will be measured in fasting serum samples

Urine concentrations of cystatin C8 weeks

Cystatin C will be analysed in morning urine as a marker of kidney function

Body composition8 weeks

Percent body fat will be measured using bioimpedance

Serum concentrations of apolipoproteins8 weeks

Lipoproteins will be measured in fasting serum samples

Serum concentration of one-carbon pathway metabolites8 weeks

Metabolites in the one-carbon pathway will be measured in fasting serum samples

Trial Locations

Locations (1)

University of Bergen

🇳🇴

Bergen, Norway

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