Cholesterol-lowering Effects of Plant Stanol Ester

Hypercholesterolemia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02316808
• Other study ID #: PCL_2011_Kal
• Status: Completed
• Phase: N/A
• First received: December 10, 2014
• Last updated: December 19, 2014
• Start date: August 2011
• Est. completion date: December 2011

Study information

• Verified date: December 2014
• Source: Raisio Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Indonesia: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemias
• Hypercholesterolemia
• Hyperlipidemias

Intervention

Dietary Supplement:
• Plant stanol ester
Smoothie that contains plant stanol ester
• placebo
Smoothie that contains placebo

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Raisio Group	Indonesia University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change (proportional) in LDL-C from baseline up to 4-weeks after plant stanol ester smoothie drink consumption.		4 weeks	No