Cholesterol-lowering Effects of Plant Stanol Ester
1 other identifier
interventional
91
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2011
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 10, 2014
CompletedFirst Posted
Study publicly available on registry
December 15, 2014
CompletedDecember 23, 2014
December 1, 2014
4 months
December 10, 2014
December 19, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Change (proportional) in LDL-C from baseline up to 4-weeks after plant stanol ester smoothie drink consumption.
4 weeks
Study Arms (2)
Placebo smoothie
PLACEBO COMPARATORPlant stanol ester smoothie
EXPERIMENTALInterventions
Smoothie that contains plant stanol ester
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Raisio Grouplead
- Indonesia Universitycollaborator
Related Publications (1)
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.
PMID: 29535869DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 10, 2014
First Posted
December 15, 2014
Study Start
August 1, 2011
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
December 23, 2014
Record last verified: 2014-12