A growing number of cross-sectional studies is investigated the role of the human lipidome as a new biomarker for metabolic diseases. However, data on this issue is still sparse and especially interventional data is not available up to now. "GesundLeben" will provide data on 100 human subjects with metabolic syndrome, undergoing distinct types of lifestyle intervention for 6 weeks. Standardized metabolic assessment will be covered with routine laboratory parameters and oral glucose tolerance test as well as non-radiologic anthropometric measurements.
A growing number of cross-sectional studies is investigated the role of the human lipidome as a new biomarker for metabolic diseases. However, data on this issue is still sparse and especially interventional data is not available up to now. We intend to clarify, if the human lipidome is correlating with metabolic state and if changes in this state reflect on the lipidome. Using high-throughput shot-gun technique, we will be able to measure several hundreds of lipid species in one blood sample. The "GesundLeben" trial will provide data on 100 human subjects with metabolic syndrome, undergoing distinct types of lifestyle intervention for 6 weeks. The cohort will be designed to include participants from both sexes, but be restricted on subjects without impaired glucose tolerance. Standardized metabolic assessment will be covered with routine laboratory parameters (e.g. transaminases, HbA1c) and oral glucose tolerance test as well as non-radiologic anthropometric measurements (BMI, WHR, BIA).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
100
Dietary treatment with or without additional motivation on more physical activity
German Institut for Human Nutrition; Department for Clinical Nutrition
Bergholz-Rehbrücke, Brandenburg, Germany
NOT_YET_RECRUITINGDIfE (German Institute for Human Nutrition)
Berlin, Germany
RECRUITINGchange in lipidome pattern
complex human lipidome (blood levels of several hundreds of lipid species) will be assessed before and after intervention
Time frame: 6 weeks
reduction of blood pressure
systolic and diastolic blood pressure
Time frame: 6 weeks
NAFLD reduction
NAFLD, estimated by fatty liver index (FLI)
Time frame: 6 weeks
weight loss
loss in body weight / BMI
Time frame: 6 weeks
reduction of insulin resistance
assessed by oral glucose tolerance test, glucose and insulin levels; IS indices (Matsuda, IGI etc.)
Time frame: 6 weeks
improvement in quality of life
standardized questionnaires
Time frame: 6 weeks
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