The Effect of a Red Rice and Olive Extract Nutrition Supplement on Cholesterol Levels in Patients With Metabolic Syndrome
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Feb 2014
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 13, 2014
CompletedFirst Posted
Study publicly available on registry
February 17, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedMay 20, 2014
May 1, 2014
3 months
February 13, 2014
May 19, 2014
Conditions
Outcome Measures
Primary Outcomes (4)
LDL level
2 months
total cholesterol level
2 months
triglyceride level
2 months
HDL level
2 months
Secondary Outcomes (6)
OxLDL
2 months
BMI
2 months
malondialdehyde (MDA)
2 months
8-OH-deoxyguanosine (8-OHdG)
2 months
side effects
2 months
- +1 more secondary outcomes
Study Arms (2)
commercially available nutrition supplement
EXPERIMENTALthis group receives a commercially available nutritional supplement for a period of 2 months
control group
PLACEBO COMPARATORthis group receives a placebo for a period of 2 months
Interventions
the food supplement contains red rice yeast and olive extract
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- pregnancy
- treatment with cholesterol lowering drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Antwerp
Antwerp, Belgie, 2610, Belgium
Related Publications (2)
Hermans N, Van der Auwera A, Breynaert A, Verlaet A, De Bruyne T, Van Gaal L, Pieters L, Verhoeven V. A red yeast rice-olive extract supplement reduces biomarkers of oxidative stress, OxLDL and Lp-PLA2, in subjects with metabolic syndrome: a randomised, double-blind, placebo-controlled trial. Trials. 2017 Jul 3;18(1):302. doi: 10.1186/s13063-017-2058-5.
PMID: 28673363DERIVEDVerhoeven V, Van der Auwera A, Van Gaal L, Remmen R, Apers S, Stalpaert M, Wens J, Hermans N. Can red yeast rice and olive extract improve lipid profile and cardiovascular risk in metabolic syndrome?: A double blind, placebo controlled randomized trial. BMC Complement Altern Med. 2015 Mar 10;15:52. doi: 10.1186/s12906-015-0576-9.
PMID: 25879228DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 13, 2014
First Posted
February 17, 2014
Study Start
February 1, 2014
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
May 20, 2014
Record last verified: 2014-05