Health Effects of CLA Versus Industrial Trans Fatty Acids

Healthy Clinical Trial

— CLARINeT  

Official title:

Health Effects of CLA Versus Industrial Trans Fatty Acids in Healthy Volunteers (CLARINeT-Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00529828
• Other study ID #: NL15599.081.07
• Status: Completed
• Phase: N/A
• First received: September 12, 2007
• Last updated: January 10, 2008
• Start date: September 2007
• Est. completion date: January 2008

Study information

• Verified date: January 2008
• Source: Wageningen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

The knowledge of the health effects of CLA on the human body is limited. However, CLA supplements are sold over the counter in several countries and various techniques are used to increase the content of CLA in food.

The CLARINeT study will be performed to investigate the effect of CLA on blood lipoproteins, inflammatory markers, blood pressure and insulin status in human volunteers relative to industrial trans fatty acids and to oleic acid.

Description:

It will be a double-blind randomized multiple cross-over trial with 3 treatments:

• CLA;

• Industrial trans fatty acids (as a positive control);

• Oleic acid (Cis 18:1, the monounsaturated fatty acid in unhydrogenated vegetable oils) as a reference fat.

Each volunteer receives each diet for three weeks, in random order, for a total of 9 weeks. Three weeks is sufficient to reach new stable lipoprotein levels.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• age 18-65 years

• healthy

Exclusion Criteria:

• serum total cholesterol >= 6,5 mmol/L

• serum triglycerides > 2,3 mmol/L

• chronic diseases (such as diabetes, cardiovascular disease, kidney and liver dysfunction)

• use of cholesterol lowering medication

• use of blood pressure lowering medication

• high alcohol intake

• BMI > 30

• pregnant and lactation women

• unusual dietary requirements

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy

Intervention

Procedure:
• Consumption of CLA enriched food

Locations

Country	Name	City	State
Netherlands	Wageningen University, Division of Human Nutrition	Wageningen

Sponsors (2)

Lead Sponsor	Collaborator
Wageningen University	VU University of Amsterdam

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total cholesterol
Primary	HDL cholesterol
Primary	LDL cholesterol
Primary	Apo B
Primary	Triglycerides
Secondary	Insulin status markers : HOMA; QUICKY
Secondary	Inflammatory markers: C-RP; IL-6; E-selectin; MCP-1; s-TNF-R1; s-TNF-R2; IFg
Secondary	Fatty acid composition of cholesteryl esters and erythrocytes
Secondary	proteomics
Secondary	iso-prostanes
Secondary	blood pressure and heart rate