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Cholesterol-lowering Effects of Plant Stanol Ester

NCT ID: NCT02316808

Last Updated: 2014-12-23

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

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2011-12-31

Brief Summary

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Efficacy of plant stanols as esters on LDL-cholesterol reduction is well documented. LDL-cholesterol lowering efficacy of the ingredient administered in a smoothie is less well known.

Detailed Description

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Conditions

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Dyslipidemias Hypercholesterolemia Hyperlipidemias

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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Placebo smoothie

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

Smoothie that contains placebo

Plant stanol ester smoothie

Group Type EXPERIMENTAL

Plant stanol ester

Intervention Type DIETARY_SUPPLEMENT

Smoothie that contains plant stanol ester

Interventions

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Plant stanol ester

Smoothie that contains plant stanol ester

Intervention Type DIETARY_SUPPLEMENT

placebo

Smoothie that contains placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* total cholesterol concentration ≥ 200 mg/dL and \< 300 mg/dL, and or LDL-C concentration ≥ 130 mg/dL and \< 180 mg/dL
* were willing to consume control or plant stanol ester smoothie drinks two bottles per day immediately after a meal for four weeks,
* reachable by phone
* willing to declare written informed consent
* agreed in accordance with data protective stipulations and readiness to participate in the trial and to adhere to the study conditions.

Exclusion Criteria

* Pregnant women
* obese
* diabetic subjects or subjects with random plasma glucose concentration \> 200 mg/dL
* hyperthyroidism, a history of metabolic, endocrine and kidney disorders
* acute or chronic severe diseases possibly interfering with the evaluation of the outcome of the clinical trial (such as AIDS, tumor diseases, malignant hypertension, cardiac insufficiency according to NYHA III-IV)
* taking lipid-lowering medication or other medications likely to affect lipid metabolism
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Indonesia University

OTHER

Sponsor Role collaborator

Raisio Group

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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Lestiani L, Chandra DN, Laitinen K, Ambarwati FD, Kuusisto P, Lukito W. Double-Blind Randomized Placebo Controlled Trial Demonstrating Serum Cholesterol Lowering Efficacy of a Smoothie Drink with Added Plant Stanol Esters in an Indonesian Population. Cholesterol. 2018 Feb 4;2018:4857473. doi: 10.1155/2018/4857473. eCollection 2018.

Reference Type DERIVED
PMID: 29535869 (View on PubMed)

Other Identifiers

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PCL_2011_Kal

Identifier Type: -

Identifier Source: org_study_id