Monocentered, randomised, placebo-controlled, double-blind cross-over study on the effect of Conjugated Linoleic Acid (CLA) on fasting and postprandial metabolic parameters and endothelial function in men with PPAR?2 P12A polymorphism and controls

Completed

• Conditions: ot applicable; Not Applicable; Not applicable

• Registration Number: ISRCTN91188075
• Lead Sponsor: Federal Research Centre for Nutrition and Food (BfEL) (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-25
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

1. Healthy male volunteers aged 45-68
2. Homozygosis of PPAR?2 P12A polymorphism
3. Member of the Metabolic Intervention Cohort Kiel (MICK)

BMI- matched controls will be recruited.

Exclusion Criteria

1. Participation in a clinical study with a medicament or a medicinal product within the last 30 days or simultaneous participation in another clinical examination
2. Inability to understand and to comply with the study protocol
3. Known metabolic or gastro-intestinal diseases, which affect the absorption, metabolism or excretion of food or food components
4. Condition after surgery of the gastro-intestinal tract, which affect gastro-intestinal motility
5. Hemoglobin <12 g/dL
6. Latex allergy
7. Diabetes (fasting glucose levels >125 mg/dl after repeated determination)
8. Surgery within the last 3 months, which still affects the current state of health
9. Intake of nitrate and/or calcium antagonists and/or alpha-blockers, which affect the blood pressure
10. Deformation of finger tips, which inhibits correct recording of EndoPAT
11. Illness of thyroid gland, which has metabolic and/or cardiovascular effect
12. Known hepatitis B, hepatitis C, HIV infection or chronic liver damage
13. Kidney insufficiency
14. Drug or alcohol abuse
15. Intake of drugs affecting the absorption, metabolism or excretion of food components or the gastro-intestinal motility
16. Intake of hormone preparations, particularly cortisone
17. Eating disorders, anorexia, bulimia, unusual outsider dietary habits
18. Psychiatric disorders, epilepsy, risk of suicide
19. For those who participate in adipose tissue biopsy, additionally:
19.1. Known allergies against local anaesthetics
19.2. Heart insufficiency
19.3. Coagulation dysfunction/consumption of drugs which may cause such dysfunctions

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of postprandial triglyceride levels (Area Under the Curve [AUC]) after 28 (±2) days supplementation. Postprandial triglyceride levels will be measured at the start of the study and after each intervention period.