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

Phase 4

Completed

• Conditions: Hypercholesterolaemia
• Interventions: Dietary Supplement: commercially available nutrition supplement; Dietary Supplement: placebo

• Registration Number: NCT02065180
• Lead Sponsor: Universiteit Antwerpen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-13
• Study First Submitted QC: 2014-02-14
• Study First Posted: 2014-02-17
• Status Verified: 2014-05
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Last Update Submitted: 2014-05-19
• Last Update Posted: 2014-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
commercially available nutrition supplement	commercially available nutrition supplement	this group receives a commercially available nutritional supplement for a period of 2 months
control group	placebo	this group receives a placebo for a period of 2 months

Primary Outcome Measures

Name	Time	Method
HDL level	2 months
LDL level	2 months
total cholesterol level	2 months
triglyceride level	2 months

Secondary Outcome Measures

Name	Time	Method
BMI	2 months
8-OH-deoxyguanosine (8-OHdG)	2 months
OxLDL	2 months
malondialdehyde (MDA)	2 months
side effects	2 months
waist circumference	2 months

Trial Locations

Locations (1)

University of Antwerp; 🇧🇪 Antwerp, Belgie, Belgium