Effects of an intervention with a Paleolithic diet in subjects with the metabolic syndrome (MetS). A pilot-study.
Completed
- Conditions
- Metabolic Syndome, Metabool syndroom, Cardiovascular risk, Cardiovasculair risico
- Registration Number
- NL-OMON22601
- Lead Sponsor
- ouis Bolk Institute, DriebergenWUR, WageningenUMCG, GroningenUniversity of Gerona, Spain
- Brief Summary
Favourable effects of consuming a Palaeolithic-type diet on characteristics of the metabolic syndrome: a randomized controlled pilot-study. <br> Inge Boers, Frits AJ Muskiet, Evert Berkelaar, Erik Schut, Ria Penders, Karine Hoenderdos, Harry J Wichers and Miek C Jong <br> Lipids in Health and Disease: http://www.lipidworld.com/content/13/1/160
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 36
Inclusion Criteria
1. Written informed consent;
2. Age ≥ 18 and < 60 years;
Exclusion Criteria
1. Diabetes mellitus type 2, cardiovascular diseases, stroke, cancer and psychological disorders;
2. Systolic blood pressure > 180 mmHg;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Parameters of the MetS:<br /><br>1. Oral glucose tolerance;<br /><br>2. Fasting insulin, glucose, systolic /diastolic blood pressure, serum total-, LDL- and HDL-cholesterol and triglycerides.<br>
- Secondary Outcome Measures
Name Time Method 1. Intestinal permeability;<br /><br>2. HOMA;<br /><br>3. Body weight and waist circumference;<br /><br>4. Inflammation parameters;<br /><br>5. Salitivary cortisol.<br /><br><br /><br /><br>Safety parameters: <br /><br>1. Adverse events;<br /><br>2. Hematology;<br /><br>3. Liver and kidney function.