|- candidate number||10186|
|- NTR Number||NTR3002|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||25-jul-2011|
|- Secondary IDs||NL31294.081.10 CCMO|
|- Public Title||Effects of an intervention with a Paleolithic diet in subjects with the metabolic syndrome (MetS). A pilot-study.|
|- Scientific Title||Effects of an intervention with a Paleolithic diet in subjects with the metabolic syndrome (MetS). A pilot-study.|
|- hypothesis||Working hypothesis is that a Palaeolithic diet can improve the parameters of the MetS: glucose tolerance, fasting insulin, fasting glucose, serum total-, LDL- and HDL-cholesterol and triglycerides, waist circumference and blood pressure through metabolic alterations that are independent of weight loss.
To study whether there are changes in the different parameters of the MetS as a result of a Palaeolithic diet compared to an isocaloric reference diet, to use this knowledge in the design of future trials.
1. To get insight which specific parameters show changes and their effect size;
2. To study other variables, which are assumed to be positively influenced by the Palaeolithic diet;
3. To study feasibility of a Palaeolithic diet.
|- Healt Condition(s) or Problem(s) studied||Metabolic syndrome, Cardiovascular disease risk|
|- Inclusion criteria||1. Written informed consent;|
2. Age ≥ 18 and < 60 years;
3. At least 2 of the following:
A. Central obesity (waist circumference ≥ 102 cm (male) and ≥ 88 cm (female);
B. Elevated triglycerides: TG ≥ 1.7 mmol /l;
C. Reduced HDL cholesterol: HDL-C < 1.0 mmol /l (male) and <1.3 mmol /l (female);
D. Raised blood pressure ≥ 130 /85 mmHg or medication for hypertension;
E. Elevated fasting plasma glucose ≥ 5.6 mmol /l;
F. Willingness not to consume alcohol during the intervention.
|- Exclusion criteria||1. Diabetes mellitus type 2, cardiovascular diseases, stroke, cancer and psychological disorders;|
2. Systolic blood pressure > 180 mmHg;
3. Smoking (within a month prior to the study);
4. 10 years mortality risk caused by cardiovascular disease > 10 % according to NHG-standard M84 Cardiovascular Risk Management (November 2006);
5. Concomitant pharmacological treatment with hypoglycemic agents, insulin, warfarin or oral steroids;
6. Participation in an other clinical trial at the same time or within the previous month prior to enrolment into this study;
7. Pregnancy or lactation;
8. Recent blood donation (within the last 2 months);
9. Severe internal or systemic disease (e.g. cardiac, hepatic, renal diseases);
10. Non –omnivore (e.g. vegan, vegetarian);
11. Unwillingness to eat fish.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mrt-2011|
|- planned closingdate||1-jul-2012|
|- Target number of participants||36|
|- Interventions||Intervention: A Paleolithic diet (2 weeks);|
Control: An isocaloric diet consistent with ‘Guidelines for a healthy diet 2006’ of the Health Council of the Netherlands (2 weeks).
|- Primary outcome||Parameters of the MetS:|
1. Oral glucose tolerance;
2. Fasting insulin, glucose, systolic /diastolic blood pressure, serum total-, LDL- and HDL-cholesterol and triglycerides.
|- Secondary outcome||1. Intestinal permeability;|
3. Body weight and waist circumference;
4. Inflammation parameters;
5. Salitivary cortisol.
1. Adverse events;
3. Liver and kidney function.
|- Timepoints||1. Visit 1 (week -2): Informed consent, run-in on usual diet, blood sampling;|
2. Visit 2 (week -0.5): Non-invasive measurements;
3. Visit 3 (week 0): Baseline blood sampling, randomization, start dietary intervention;
4. Visit 4 (week 2): Non-invasive measurements;
5. Visit 5 (week 2 + 1 day): Blood sampling, end of study.
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||Dr. M. Jong|
|- CONTACT for SCIENTIFIC QUERIES||Dr. M. Jong|
|- Sponsor/Initiator ||Louis Bolk Institute, Wageningen University (WUR), University Medical Center Groningen (UMCG)|
(Source(s) of Monetary or Material Support)
|Innovatienetwerk, University of Gerona, Spain, Fonds van het Hart, Louis Bolk Instituut|
|- Publications||Favourable effects of consuming a Palaeolithic-type diet on characteristics of the metabolic syndrome: a randomized controlled pilot-study. |
Inge Boers, Frits AJ Muskiet, Evert Berkelaar, Erik Schut, Ria Penders, Karine Hoenderdos, Harry J Wichers and Miek C Jong
Lipids in Health and Disease: http://www.lipidworld.com/content/13/1/160
|- Brief summary||N/A|
|- Main changes (audit trail)|
|- RECORD||25-jul-2011 - 8-nov-2014|