Cholesterol-lowering Effects of Plant Stanol Ester

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.

Study Overview

• Status: Completed
• Conditions: Dyslipidemias; Hypercholesterolemia; Hyperlipidemias
• Intervention / Treatment: Dietary supplement: placebo; Dietary supplement: Plant stanol ester

• Study Type: Interventional
• Enrollment (Actual): 91
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo smoothie	Dietary supplement: placebo; Smoothie that contains placebo
Experimental: Plant stanol ester smoothie	Dietary supplement: Plant stanol ester; Smoothie that contains plant stanol ester

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change (proportional) in LDL-C from baseline up to 4-weeks after plant stanol ester smoothie drink consumption.	4 weeks

Collaborators and Investigators

• Sponsor: Raisio Group
• Collaborators: Indonesia University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: December 10, 2014
• First Submitted That Met QC Criteria: December 10, 2014
• First Posted (Estimate): December 15, 2014

Study Record Updates

• Last Update Posted (Estimate): December 23, 2014
• Last Update Submitted That Met QC Criteria: December 19, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hypercholesterolemia; Hyperlipidemias
• Other Study ID Numbers: PCL_2011_Kal