No registrations found.
ID
Source
Health condition
Metabolic Syndome, Metabool syndroom, Cardiovascular risk, Cardiovasculair risico
Sponsors and support
WUR, Wageningen
UMCG, Groningen
University of Gerona, Spain
Intervention
Outcome measures
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;
2. HOMA;
3. Body weight and waist circumference;
4. Inflammation parameters;
5. Salitivary cortisol.
Safety parameters:
1. Adverse events;
2. Hematology;
3. Liver and kidney function.
Background summary
N/A
Study objective
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.
Study design
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.
Intervention
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).
Hoofdstraat 24
M. Jong
Driebergen 3972 LA
The Netherlands
+31 (0)343 523860
m.jong@louisbolk.nl
Hoofdstraat 24
M. Jong
Driebergen 3972 LA
The Netherlands
+31 (0)343 523860
m.jong@louisbolk.nl
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2860 |
| NTR-old | NTR3002 |
| CCMO | NL31294.081.10 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON36767 |
Summary results
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