Lipid-lowering Effect of a Plant Stanol Ester Supplement Product

NCT02221297 | Completed

• 1 other identifier: CL2014_035
• Study Type: interventional
• Target: 103
• Locations: 0 countries
• Sites: N/A

Brief Summary

Purpose of the study is to determine the effect of the investigational products as consumed with a meal on serum lipids, primarily on LDL cholesterol.

Conditions

Hypercholesterolemia; Hyperlipidemias; Dyslipidemias

Outcome Measures

Primary Outcomes (1)

• Proportional change in serum LDL cholesterol

  Proportional change \[end of intervention - start of intervention\] in serum LDL-cholesterol between intervention and control groups in subjects fulfilling the inclusion criteria at the beginning of the study.

  3 to 4 weeks

Secondary Outcomes (5)

• Proportional change in total cholesterol

  3 to 4 weeks

• Proportional change in non-HDL-cholesterol

  3 to 4 weeks

• Proportional change in serum triglycerides

  3 to 4 weeks

• Proportional change in lipids in all study participants

  3 to 4 weeks

• Proportional change in lipids in subjects without metabolic derangements

  3 to 4 weeks

Study Arms (2)

Supplement product with plant stanol ester

EXPERIMENTAL

Dietary Supplement: Supplement product with plant stanol ester

Placebo supplement product

PLACEBO COMPARATOR

Dietary Supplement: Supplement product with plant stanol ester

Interventions

Supplement product with plant stanol ester DIETARY_SUPPLEMENT

2 grams plant stanols consumed with a meal daily for 3 to 4 weeks

Placebo supplement product; Supplement product with plant stanol ester

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• male and female over 18 years old
• serum LDL cholesterol \> 3.0 mmol/L
• BMI \< 35
• subjects must voluntarily sign the informed consent

You may not qualify if:

• subjects using lipid lowering medication (ezetimibe, bile acid sequestrant, statin therapy)
• subjects with any hepatic or renal disorder according to medical history
• subjects who have history of myocardial infarction or unstable angina pectoris within six months prior to screening
• subjects who have history of coronary artery bypass graft or percutaneous transluminal coronary angioplasty within six months prior to screening
• subjects who have history of temporal ischemic attack or stroke within six months prior to screening
• subjects who have a history of cancer or other malignant disease within the past five years
• subjects who are consuming more than 15 portions of alcohol / week
• subjects who are pregnant or lactating
• subjects using cholesterol-lowering foods or dietary supplements within 14 days before start of the intervention
• subjects with intolerance to any ingredient of the test product

Sponsors & Collaborators

• Raisio Group: lead
• Clinical Research Institute HUCH Ltd: collaborator

MeSH Terms

Conditions

Hypercholesterolemia; Hyperlipidemias; Dyslipidemias

Interventions

plant stanol ester

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

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: August 19, 2014
• First Posted: August 20, 2014
• Study Start: May 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: October 29, 2015

Record last verified: 2015-10