The Effect of a Red Rice and Olive Extract Nutrition Supplement on Cholesterol Levels in Patients With Metabolic Syndrome

Universiteit Antwerpen

Status and phase: Completed; Phase 4

Conditions: Hypercholesterolaemia

Treatments: Dietary Supplement: placebo; Dietary Supplement: commercially available nutrition supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT02065180

verhoevenhermans

Details and patient eligibility

About

This randomised controlled trial studies the effect of a commercially available nutritional supplement on cholesterol levels in people with metabolic syndrome and elevated cholesterol levels.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• metabolic syndrome according to ATPIII criteria 3 of the following:

  • waist circumference >88cm (in females) or >102cm (in males)
  • triglycerides >150mg/dl
  • HDL <40 (50)mg/dl in males (females)
  • blood pressure>130/85 or treatment for AHT
  • glucose >110mg/dl

Exclusion criteria

• pregnancy
• treatment with cholesterol lowering drugs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

50 participants in 2 patient groups, including a placebo group

commercially available nutrition supplement

Experimental group

Description:

this group receives a commercially available nutritional supplement for a period of 2 months

Treatment:

Dietary Supplement: commercially available nutrition supplement

control group

Placebo Comparator group

Description:

this group receives a placebo for a period of 2 months

Treatment:

Dietary Supplement: placebo