Efficacy Study on the Lipid-lowering Effect of Plant Sterols and Fish Oil

Unilever

Status: Completed

Conditions: Healthy; Mildly Elevated Cholesterol Levels

Treatments: Dietary Supplement: Plant sterols; Dietary Supplement: Placebo; Dietary Supplement: Plant sterols and fish oil

Study type: Interventional

Funder types: Industry

Identifiers

NCT01313988

10018V

Details and patient eligibility

About

Plant sterols and fish fatty acids are known to affect the blood lipid profile. This randomized, double-blind, placebo-controlled, parallel efficacy study is designed to investigate the lipid-lowering effect after 4 weeks intervention with the recommended dose of plant sterols and different doses of fish fatty acids when combined in a spread format.

Enrollment: 332 patients

Sex: All

Ages: 25 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Apparently healthy men and women
• Age ≥ 25 and ≤ 75 years old
• Body mass index (BMI) ≥ 18 and ≤ 30 kg/m2
• Total cholesterol levels at screening ≥ 5.0 and ≤ 8.0 mmol/L
• 10-year CVD risk equal or lower than 10% according to "SCORE"
• Blood pressure, heart rate, hematological parameters, clinical chemical parameters within normal reference ranges
• Informed consent and biobank consent signed
• Willing to comply to study protocol during study
• Agreeing to be informed about medically relevant personal test-results by a physician
• Not smoking
• Accessible veins on the forearm
• Habitually consuming spreads

Exclusion criteria

• Pregnant or having the wish to become pregnant, or lactating
• Use of prescribed medication which may interfere with study measurements
• Use of antibiotics in the 3 months before screening or during the study
• Use of any medically- or self-prescribed diet with the purpose to reduce weight
• Intolerance for gluten or lactose
• Reported food allergy
• Having bleeding disorders
• Recent blood donation
• Excessive alcohol consumption
• Strenuous exercise
• Reported weight change ≥ 10 % of body weight or use of prescribed weight reduction drugs
• Recent participation in another nutritional or medical trial
• Participation in night shift work

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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332 participants in 5 patient groups, including a placebo group

Dose 1

Active Comparator group

Description:

Spread that contains plant sterols and fish oil

Treatment:

Dietary Supplement: Plant sterols and fish oil

Dose 2

Active Comparator group

Description:

Spread that contains plant sterols and fish oil

Treatment:

Dietary Supplement: Plant sterols and fish oil

Dose 3

Active Comparator group

Description:

Spread that contains plant sterols and fish oil

Treatment:

Dietary Supplement: Plant sterols and fish oil

Placebo

Placebo Comparator group

Description:

Placebo spread

Treatment:

Dietary Supplement: Placebo

Control

Active Comparator group

Description:

Spread that contains plant sterols

Treatment:

Dietary Supplement: Plant sterols