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CompletedNCT02331043Updated Jan 8, 2015

Serum Cholesterol Reduction Efficacy of Biscuit With Plant Stanol Ester

An interventional study of Plant stanol ester and Placebo in Dyslipidemias, Hypercholesterolemia and Hyperlipidemias, sponsored by Raisio Group. Completed at 1 site in Thailand. Open to participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-01-08.

Sponsored by Raisio Group · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
119
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
All
01

Study summary

Efficacy of plant stanols as esters on LDL-cholesterol reduction is well documented. LDL-cholesterol lowering efficacy of the ingredient in a biscuit (providing 2 g plant stanols as esters per day) is less well known.

02

Conditions studied

  • Dyslipidemias
  • Hypercholesterolemia
  • Hyperlipidemias
03

In context

Hypercholesterolemia

1,238 studies on the registry are indexed under Hypercholesterolemia; 109 are open to participants now.

This study's enrollment of 119 is above the median of 99 across 991 interventional studies indexed under Hypercholesterolemia.

Browse Hypercholesterolemia studies →

Lead sponsor

Raisio Group is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • mildly or elevated fasting serum cholesterol levels (between 5.2 to 6.5 mmol/l)
  • fasting serum triglyceride levels below 3.0 mmol/l
  • normal liver, kidney and thyroid function
  • no lipid lowering medication
  • no history of unstable coronary artery disease (myocardial infarction, coronary artery bypass craft (CABG), percutaneous transluminal coronary angioplasty (PTCA) within the previous 6 months, diabetes, temporal ischemic attack and malignant diseases

Exclusion criteria

Exclusion Criteria:

  • alcohol abuse (> 4 portion/per day)
  • pregnancy
  • use of plant stanol and plant sterol products and equivalent cholesterol lowering products, though the ones who have discontinued the consumption of these products minimum 3 weeks before the beginning of the study, can be included
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
119 participants (actual)

Study arms

  • Placebo comparator
    Placebo biscuit

    Biscuit without plant stanol ester

    Dietary Supplement: Placebo

  • Experimental
    Plant stanol ester biscuit

    Biscuit with plant stanol esters

    Dietary Supplement: Plant stanol ester

Interventions

  • Dietary supplementPlant stanol ester
  • Dietary supplementPlacebo
06

What researchers measure

Primary outcomes

  1. Change (proportional) in LDL-c from baseline after 4-weeks' plant stanol ester biscuit consumption compared to controls

    Time frame: 4 weeks

Secondary outcomes

  1. Change (proportional) in LDL-c from baseline after 4-weeks' plant stanol ester biscuit consumption in subjects consuming the biscuit with or without a meal

    Time frame: 4 weeks

07

Study locations

1 site
  • Mahidon University, Nutrition Institute, Center of Innovation and Reference on Food for Nutrition (CIRFON)
    Phutthamonthon, Nakhon Pathom 73170, Thailand
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 8, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02331043
Lead sponsor
Raisio Group
Collaborators
Mahidol University
Responsible party
Sponsor
First posted
Jan 5, 2015
Start date
Mar 2013
Primary completion
Aug 2013
Completion
Aug 2013
Last update
Jan 8, 2015

Study contacts

Wantanee Kriengsinyos, PhD
principal investigator · Mahidol University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

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Discussion

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