Conjugated Linoleic Acid and Atherosclerosis

NCT00706745 | Completed Phase 3 DMC

• 1 other identifier: CLA362
• Study Type: interventional
• Target: 401
• Locations: 1 country
• Sites: 1

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.

Conditions

Atherosclerosis

Keywords

atherosclerosis; dietary supplements; randomised controlled trial; arterial stiffness; linoleic acid

Outcome Measures

Primary Outcomes (1)

• The main study outcome is difference between treatment arms in change in aortic pulse wave velocity after 6 months intervention.

  6 months

Secondary Outcomes (1)

• 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).

  6 months

Study Arms (2)

placebo

PLACEBO COMPARATOR

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.

Dietary Supplement: oil rich in cis9, trans11 conjugated linoleic acid; Dietary Supplement: placebo

oil rich in cis9, trans11 CLA

ACTIVE COMPARATOR

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.

Dietary Supplement: oil rich in cis9, trans11 conjugated linoleic acid; Dietary Supplement: placebo

Interventions

oil rich in cis9, trans11 conjugated linoleic acid DIETARY_SUPPLEMENT

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.

Also known as: oil rich in cis9, trans11 CLA

oil rich in cis9, trans11 CLA; placebo

placebo DIETARY_SUPPLEMENT

identical placebo capsules.

Also known as: no other names

oil rich in cis9, trans11 CLA; placebo

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• UMC Utrecht: lead
• University of Aberdeen: collaborator
• Lipid Nutrition B.V: collaborator
• Center Novem: collaborator

Study Sites (1)

Julius Center for Health Sciences and Primary Care, UMC Utrecht

Utrecht, Utrecht, 3584 CX, Netherlands

Location

Related Publications (2)

• Sluijs I, Plantinga Y, de Roos B, Mennen LI, Bots ML. Dietary supplementation with cis-9,trans-11 conjugated linoleic acid and aortic stiffness in overweight and obese adults. Am J Clin Nutr. 2010 Jan;91(1):175-83. doi: 10.3945/ajcn.2009.28192. Epub 2009 Nov 18.

  PMID: 19923377 RESULT

• Bachmair EM, Bots ML, Mennen LI, Kelder T, Evelo CT, Horgan GW, Ford I, de Roos B. Effect of supplementation with an 80:20 cis9,trans11 conjugated linoleic acid blend on the human platelet proteome. Mol Nutr Food Res. 2012 Jul;56(7):1148-59. doi: 10.1002/mnfr.201100763. Epub 2012 May 30.

  PMID: 22648731 RESULT

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Michiel L Bots, MD, PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Epidemiology of Cardiovascular Disease

Study Record Dates

• First Submitted: June 26, 2008
• First Posted: June 30, 2008
• Study Start: June 1, 2007
• Primary Completion: November 1, 2008
• Study Completion: December 1, 2008
• Last Updated: June 15, 2015

Record last verified: 2015-06

Locations

NL (1)