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Trial record 10 of 37 for:    conjugated linoleic acid

Conjugated Linoleic Acid and Atherosclerosis

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ClinicalTrials.gov Identifier: NCT00706745
Recruitment Status : Completed
First Posted : June 30, 2008
Last Update Posted : June 15, 2015
Sponsor:
Collaborators:
University of Aberdeen
Lipid Nutrition B.V
Center Novem
Information provided by (Responsible Party):
Michiel L. Bots, UMC Utrecht

Tracking Information
First Submitted Date  ICMJE June 26, 2008
First Posted Date  ICMJE June 30, 2008
Last Update Posted Date June 15, 2015
Study Start Date  ICMJE June 2007
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2008)
The main study outcome is difference between treatment arms in change in aortic pulse wave velocity after 6 months intervention. [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00706745 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2008)
change in serum lipids (total, LDL- and HDL cholesterol and triglycerides) and change in systolic and diastolic blood pressure and platelet biomarkers of haemostatic function (proteomics). [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Conjugated Linoleic Acid and Atherosclerosis
Official Title  ICMJE Possible Effects of Supplementation With Cis-9, Trans-11 Conjugated Linoleic Acid on Markers of Atherosclerosis
Brief Summary

Rationale: Cis-9, trans-11 conjugated linoleic acid (CLA) can protect against the atherosclerosis development in several animal models. Studies in transgenic mice have shown that mechanisms might involve beneficial effects on lipoprotein metabolism and insulin sensitivity and in addition activation of anti-inflammatory pathways. A very limited amount of human studies have not shown similar beneficial effect of cis9,trans11-CLA on insulin sensitivity in obese subjects, yet cis9,trans11-CLA did improve the lipoprotein profile in healthy subjects. The effect of cis9,trans11-CLA supplementation on alternative early biomarkers of atherosclerosis, like aortic pulse wave velocity, and alternative biomarkers identified through platelet proteomics, has not been assessed before, and may add valuable insights into the mechanism of this functional fatty acid in humans.

Objective: To assess the effect of increased intake of cis9 trans11-CLA on development of atherosclerosis, as assessed with aortic pulse wave velocity and on alternative biomarkers.

Study design: The study is designed as a double blind randomised placebo controlled parallel group trial.

Study population: 400 men and women, between 40 and 70 years of age, with a body mass index of 25 kg/m2 or above. Subjects with previous symptomatic vascular disease or diabetes mellitus and subjects on blood pressure lowering or lipid lowering medication are excluded.

Intervention: Subjects in the intervention arm will receive daily 4 g of CLA oil (2.6 g cis9,trans11-CLA), 2 capsules to be taken in the morning and 2 in the evening. The subjects in the control arm receive 4 identical placebo capsules.

Main study parameters/endpoints: The main study outcome is difference between treatment arms in change in aortic pulse wave velocity after 6 months intervention.

Detailed Description

Rationale: Cis-9, trans-11 conjugated linoleic acid (CLA) can protect against the atherosclerosis development in several animal models. Studies in transgenic mice have shown that mechanisms might involve beneficial effects on lipoprotein metabolism and insulin sensitivity and in addition activation of anti-inflammatory pathways. A very limited amount of human studies have not shown similar beneficial effect of cis9,trans11-CLA on insulin sensitivity in obese subjects, yet cis9,trans11-CLA did improve the lipoprotein profile in healthy subjects. The effect of cis9,trans11-CLA supplementation on alternative early biomarkers of atherosclerosis, like aortic pulse wave velocity, and alternative biomarkers identified through platelet proteomics, has not been assessed before, and may add valuable insights into the mechanism of this functional fatty acid in humans.

Objective: To assess the effect of increased intake of cis9 trans11-CLA on development of atherosclerosis, as assessed with aortic pulse wave velocity and on alternative biomarkers.

Study design: The study is designed as a double blind randomised placebo controlled parallel group trial.

Study population: The study population comprises 400 men and women, between 40 and 70 years of age, with a body mass index of 25 kg/m2 or above. Subjects with previous symptomatic vascular disease or diabetes mellitus and subjects on blood pressure lowering or lipid lowering medication are excluded.

Intervention: Subjects in the intervention arm will receive daily 4 g of CLA oil (2.6 g cis9,trans11-CLA), 2 capsules to be taken in the morning and 2 in the evening. The subjects in the control arm receive 4 identical placebo capsules.

Main study parameters/endpoints: The main study outcome is difference between treatment arms in change in aortic pulse wave velocity after 6 months intervention. Secondary outcomes are differences between treatment groups in change in serum lipids (total, LDL- and HDL cholesterol and triglycerides) and change in systolic and diastolic blood pressure, as well as in F2-isoprostanes and platelet biomarkers of haemostatic function (proteomics). Blood samples will be stored for assessment of plasma parameters of glucose intolerance, inflammation and endothelial function.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The assessment of aortic pulse wave velocity is non-invasive and does not carry any risks nor has any side effects. The assessment of lipids and blood pressure might sometimes carry some discomfort but can be seen as routine procedures. Completion of questionnaire needs to done once. The participants need to come to the research center three times. Based on findings of several short-term and long-term studies using the compound, no excess serious adverse events were found.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Atherosclerosis
Intervention  ICMJE
  • Dietary Supplement: oil rich in cis9, trans11 conjugated linoleic acid
    An oil rich in cis9, trans11 conjugated linoleic acid (cis9,trans11-CLA). Of the total amount of CLA in the oil, 80% is cis9, trans11-CLA and 20% trans10, cis12-CLA. In total 4 grams of oil will be given daily. The oil will be taken in the form of soft gel capsules. Two capsules will be taken in the morning and two in the evening.
    Other Name: oil rich in cis9, trans11 CLA
  • Dietary Supplement: placebo
    identical placebo capsules.
    Other Name: no other names
Study Arms  ICMJE
  • Placebo Comparator: placebo
    The control oil is based on the general fat consumption in a Western population and consists of an equal amount (4 gr) of fat. It is a blend of palm (80%) and soybean oil (20%). Two capsules will be taken in the morning and two in the evening.
    Interventions:
    • Dietary Supplement: oil rich in cis9, trans11 conjugated linoleic acid
    • Dietary Supplement: placebo
  • Active Comparator: oil rich in cis9, trans11 CLA
    Subjects will receive daily 4 g of CLA oil (2.6 g cis9,trans11-CLA), 2 capsules to be taken in the morning and 2 in the evening.
    Interventions:
    • Dietary Supplement: oil rich in cis9, trans11 conjugated linoleic acid
    • Dietary Supplement: placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 27, 2008)
401
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Written and signed informed consent
  • Healthy men and women
  • Between 40-70 years of age
  • Body mass index > 25 kg/m2

Exclusion Criteria:

  • Inability to understand the patient information
  • Inability to speak, read and understand the Dutch language
  • Indication (BP over 160/90) or using blood pressure lowering drugs
  • Indication (total cholesterol > 8 mmol/l) or using lipid lowering drugs
  • Indication (glucose > 7 mmol/l) or using glucose lowering drugs
  • Alcohol abuse (>21 alcoholic beverages per week)
  • Women who are pregnant, lactating or who are planning to become pregnant
  • Symptomatic vascular disease
  • Use of fish oils (omega 3/6,capsules or oil)
  • Use of plant stanols/sterols (margarines like benecol, pro active)
  • Use of weight loss supplements
  • Receipt of any investigational treatment (drug or device) within 30 days prior to visit 1
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00706745
Other Study ID Numbers  ICMJE CLA362
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michiel L. Bots, UMC Utrecht
Study Sponsor  ICMJE UMC Utrecht
Collaborators  ICMJE
  • University of Aberdeen
  • Lipid Nutrition B.V
  • Center Novem
Investigators  ICMJE
Principal Investigator: Michiel L Bots, MD, PhD UMC Utrecht
PRS Account UMC Utrecht
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP