Lipid-lowering Effect of Plant Stanol Drink

Raisio Group

Status: Completed

Conditions: Hypercholesterolemia

Treatments: Dietary Supplement: Placebo drink; Dietary Supplement: Drink that contains plant stanols

Study type: Interventional

Funder types: Industry

Identifiers

NCT01716390

CL2010_029

Details and patient eligibility

About

To determine the effect of investigational products on serum LDL cholesterol.

Enrollment: 56 patients

Sex: All

Ages: 25 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy mildly to moderate hypercholesterolemic (serum total cholesterol 5.2-8.5 mmol/l) adults
• signed written informed consent

Exclusion criteria

• participation in a clinical study within 30 days prior to screening visit and throughout the study
• severe obesity
• consumption of lipid/cholesterol lowering medication 1 month prior to the screening visit and throughout the study
• consumption of plant stanol or plant sterol containing food products such as Benecol or Becel pro active 1 month prior to visit 2

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

56 participants in 2 patient groups, including a placebo group

Drink that contains plant stanols

Active Comparator group

Description:

Dietary supplement: Plant stanol

Treatment:

Dietary Supplement: Drink that contains plant stanols

Placebo drink

Placebo Comparator group

Description:

Dietary supplement: Placebo

Treatment:

Dietary Supplement: Placebo drink