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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON36767
Enrollment
36
Registered
2011-04-11
Start date
2011-10-20
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

high risk for cardovascular diseases and diabetes mellitus Metabolic Syndrome

Interventions

A Paleolithic diet for 14 days compared to an isocaloric diet consistent with *Guidelines for a healthy diet 2006* of the Health Council of the Netherlands.

Sponsors

Louis Bolk Instituut
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -Written informed consent -Age >= 18 and = 102 cm (male) and >= 88 cm (female) -Elevated triglycerides: TG >= 1.7 mmol/L -Reduced HDL cholesterol: HDL-C = 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

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

Design outcomes

Primary

MeasureTime frame
Parameters of the MetS: •Oral glucose tolerance •Fasting insulin, glucose, systolic /diastolic blood pressure, serum total-, LDL- and HDL-cholesterol and triglycerides .

Secondary

MeasureTime frame
•Intestinal permeability •HOMA •Body weight and waist circumference •Inflammation parameters •Salitivary cortisol

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)