Cholesterol-lowering Effects of Plant Stanol Ester

Raisio Group

Status: Completed

Conditions: Hyperlipidemias; Dyslipidemias; Hypercholesterolemia

Treatments: Dietary Supplement: placebo; Dietary Supplement: Plant stanol ester

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02316808

PCL_2011_Kal

Details and patient eligibility

About

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.

Enrollment: 91 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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91 participants in 2 patient groups, including a placebo group

Placebo smoothie

Placebo Comparator group

Treatment:

Dietary Supplement: placebo

Plant stanol ester smoothie

Experimental group

Treatment:

Dietary Supplement: Plant stanol ester