Lipid-lowering Effect of Plant Stanol Ester Yoghurt Drinks

NCT ID: NCT02628990

Last Updated: 2015-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

155 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2005-11-30

Brief Summary

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The aim is to investigate the effects of yoghurt drinks containing two doses of plant stanol ester either with or without added camelina oil on the serum cholesterol levels in moderately hypercholesterolemic subjects

Detailed Description

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Conditions

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Hypercholesterolemia Hyperlipidemias Dyslipidemias

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1.6 g plant stanols

A yoghurt drink containing plant stanol ester (1.6 grams plant stanols), consumed with a meal daily for 4 weeks

Group Type EXPERIMENTAL

1.6 g plant stanols

Intervention Type OTHER

Lipid-lowering effect of Yoghurt Drink with 1.6 g plant stanols

2 g plant stanols

A yoghurt drink containing plant stanol ester (2 grams plant stanols), consumed with a meal daily for 4 weeks

Group Type EXPERIMENTAL

2 g plant stanols

Intervention Type OTHER

Lipid-lowering effect of Yoghurt Drink with 2 g plant stanols

1.6 g plant stanols and camelina oil

A yoghurt drink containing plant stanol ester (1.6 grams plant stanols) and camelina oil (2 g), consumed with a meal daily for 4 weeks

Group Type EXPERIMENTAL

1.6 g plant stanols and camelina oil

Intervention Type OTHER

Lipid-lowering effect of Yoghurt Drink with 1.6 g plant stanols and camelina oil

2 g plant stanols and camelina oil

A yoghurt drink containing plant stanol ester (2 grams plant stanols) and camelina oil (2 g), consumed with a meal daily for 4 weeks

Group Type EXPERIMENTAL

2 g plant stanols and camelina oil

Intervention Type OTHER

Lipid-lowering effect of Yoghurt Drink with 2 g plant stanols and camelina oil

Placebo

A placebo yoghurt drink, consumed with a meal daily for 4 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Lipid-lowering effect of Placebo Yoghurt Drink

Interventions

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1.6 g plant stanols

Lipid-lowering effect of Yoghurt Drink with 1.6 g plant stanols

Intervention Type OTHER

2 g plant stanols

Lipid-lowering effect of Yoghurt Drink with 2 g plant stanols

Intervention Type OTHER

1.6 g plant stanols and camelina oil

Lipid-lowering effect of Yoghurt Drink with 1.6 g plant stanols and camelina oil

Intervention Type OTHER

2 g plant stanols and camelina oil

Lipid-lowering effect of Yoghurt Drink with 2 g plant stanols and camelina oil

Intervention Type OTHER

Placebo

Lipid-lowering effect of Placebo Yoghurt Drink

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* BMI \< 30 kg/m2
* moderate hypercholesterolemia (fasting total cholesterol between 5-8 mmol/l)
* serum triglycerides \< 3 mmol/l.
* normal liver, kidney and thyroid function
* subjects must voluntarily sign the informed consent

Exclusion Criteria

* use of cholesterol lowering foods or dietary supplements within 21 days before the start of the intervention
* lipid lowering medication
* history of unstable coronary artery disease (myocardial infarction, coronary artery bypass craft (CABG), percutaneous transluminal coronary angioplasty (PTCA) within the previous 6 months, diabetes, hyperglycemia, temporal ischemic attack and malignant diseases
* pregnancy or lactation
* alcohol abuse
* subjects with intolerance to any ingredient of the test products
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Turku

OTHER

Sponsor Role collaborator

Raisio Group

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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Salo P, Kuusisto P. Cholesterol Lowering Effect of Plant Stanol Ester Yoghurt Drinks with Added Camelina Oil. Cholesterol. 2016;2016:5349389. doi: 10.1155/2016/5349389. Epub 2016 Feb 21.

Reference Type DERIVED
PMID: 26998355 (View on PubMed)

Other Identifiers

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YD2005

Identifier Type: -

Identifier Source: org_study_id