Mono-centred, randomised, placebo-controlled, double-blind parallel-arm study on the effect of Conjugated Linoleic Acid (CLA) on endothelial function and (postprandial) metabolic parameters in overweight me

Completed

• Conditions: Cardiovascular disease; Circulatory System; Complications and ill-defined descriptions of heart disease

• Registration Number: ISRCTN30870177
• Lead Sponsor: Max Rubner Institute (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-17
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 88

Inclusion Criteria

1. Healthy male volunteers
2. Aged 45 - 68 years
3. Body mass index (BMI) 25 - 29 kg/m^2
4. Member of the Metabolic Intervention Cohort Kiel (MICK)
5. Written informed consent

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 affects gastro-intestinal motility
5. Haemoglobin less than 12 g/dL
6. Latex allergy
7. Diabetes (fasting glucose levels greater than 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, which affect the blood pressure
10. Deformation of finger tips, which inhibits correct recording of EndoPAT (measures a Peripheral Arterial Tone [PAT™] signal for assessment of endothelial dysfunction)
11. Illness of thyroid gland, which has metabolic and/or cardiovascular effect
12. Known hepatitis B, hepatitis C, human immunodeficiency virus (HIV) infection or chronic liver disease
13. Kidney malfunction
14. Psychiatric disorders, epilepsy, risk of suicide
15. Drug or alcohol abuse
16. Intake of drugs affecting the absorption, metabolism or excretion of food components or the gastro-intestinal motility
17. Intake of hormone preparations, particularly cortisone
18. Eating disorders, anorexia, bulimia, unusual outsider dietary habits
19. Legal incapacity
20. Others depending on the judgement of the study physician

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in endothelial function: PAT-Index after 28(± 2) days supplementation.