Effect of Herring Oil Concentrate on LDL Cholesterol Concentration in Adults

High Cholesterol Clinical Trial

Official title:

A Study on the Effect of Consuming a Herring Oil Concentrate on LDL Cholesterol Concentration in Adults With Overweight or Obesity

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06364163
• Other study ID #: 697716
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 12, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: April 2024
• Source: University of Bergen
• Contact: Oddrun A Gudbrandsen, PhD
• Phone: 55975553
• Email: nkjgu[@]uib.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• High Cholesterol
• Hypercholesterolemia

Intervention

Dietary Supplement:
• Herring oil concentrate
Capsules containing herring oil concentrate, taken daily for 8 weeks.
• Control
Capsules containing control oil, taken daily for 8 weeks.

Locations

Country	Name	City	State
Norway	University of Bergen	Bergen

Sponsors (2)

Lead Sponsor	Collaborator
University of Bergen	The Norwegian Seafood Research Fund

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum concentration of LDL-cholesterol	LDL-cholesterol will be measured in fasting serum samples	8 weeks
Secondary	Serum concentration of HDL-cholesterol	HDL-cholesterol will be measured in fasting serum samples	8 weeks
Secondary	Serum concentration of total cholesterol	Total cholesterol will be measured in fasting serum samples	8 weeks
Secondary	Serum concentrations of apolipoproteins	Lipoproteins will be measured in fasting serum samples	8 weeks
Secondary	Serum concentrations of amino acids metabolites	Metabolites of amino acids will be measured in fasting serum samples	8 weeks
Secondary	Serum concentration of one-carbon pathway metabolites	Metabolites in the one-carbon pathway will be measured in fasting serum samples	8 weeks
Secondary	Fatty acid composition in leukocytes	Leukocytes will be isolated from fasting serum before quantification of fatty acids	8 weeks
Secondary	Serum concentration of glucose	Glucose will be measured in serum sampled in fasting condition	8 weeks
Secondary	Serum concentration of insulin	Insulin will be measured in serum sampled in fasting condition	8 weeks
Secondary	Urine concentrations of cystatin C	Cystatin C will be analysed in morning urine as a marker of kidney function	8 weeks
Secondary	Urine concentrations of T cell immunoglobulin mucin-1 (TIM-1)	T cell immunoglobulin mucin-1 (TIM-1) will be analysed in morning urine as a marker of kidney function	8 weeks
Secondary	Body composition	Percent body fat will be measured using bioimpedance	8 weeks