Effects of a Paleolithic diet in subjects with markers of the metabolic syndrome. A pilot-study.

Completed

Conditions: high risk for cardovascular diseases and diabetes mellitus
Metabolic Syndrome
10018424
10057166

Registration Number: NL-OMON36767

Lead Sponsor: ouis Bolk Instituut

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 34

Inclusion Criteria

-Written informed consent
-Age >= 18 and < 70 years
-At least 2 of the following:
-Central obesity (waist circumference >= 102 cm (male) and >= 88 cm (female)
-Elevated triglycerides: TG >= 1.7 mmol/L
-Reduced HDL cholesterol: HDL-C < 1.0 mmol/l (male) and <1.3 mmol/l (female)
-Raised blood pressure >= 130/85 mmHg or medication for hypertension
-Elevated fasting plasma glucose >= 5.6 mmol/L
•Willingness to not consume alcohol during the intervention

Exclusion Criteria

-Diabetes mellitus type 2, cardiovascular diseases, stroke, cancer and psychological disorders
-Systolic bloodpressure > 180 mmHg
-Smoking (within a month prior to the study)
-10 years mortality risk caused by cardiovascular disease > 10 % according to NHG-standard M84 Cardiovascular Risk Management (November 2006)
-Concomitant pharmacological treatment with hypoglycaemic agents, insulin, warfarin or oral steroids
-Participation in an other clinical trial at the same time or within the previous month prior to enrolment into this study
-Pregnancy or lactation
-Recent blood donation (within the last 2 months)
-Severe internal or systemic disease (e.g. cardiac, hepatic, renal diseases).
-Non -omnivore (e.g. vegan, vegetarian)
-Unwillingness to eat fish

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Parameters of the MetS:<br /><br>•Oral glucose tolerance<br /><br>•Fasting insulin, glucose, systolic /diastolic blood pressure, serum total-,<br /><br>LDL- and HDL-cholesterol and triglycerides .</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>•Intestinal permeability<br /><br>•HOMA<br /><br>•Body weight and waist circumference<br /><br>•Inflammation parameters<br /><br>•Salitivary cortisol</p><br>