Effects of Short-term Interventions for a Healthy Lifestyle on the Human Lipidome in Subjects With Metabolic Syndrome

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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).

Conditions
-----------------
Metabolic Syndrome, NAFLD, Obesity, Hypertension

Intervention / Treatment
-----------------
* Behavioral: Lifestyle intervention (physical activity)
* Dietary Supplement: Lifestyle intervention (PUFA/isomaltulose-enriched muffin)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hypertension NAFLD obesity hyperuricemia dyslipoproteinemia Exclusion Criteria: prediabetes / overt diabetes mellitus present cancer systemic infection chronic inflammatory disease recent stroke / myocardial infarction (6 months) pregnancy addiction / severe psychiatric diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Physical activity only<br>pedometers have to be used throughout all days; daily amount of steps is reported via App or website; 10000 steps are defined as daily goal | Behavioral: Lifestyle intervention (physical activity)<br>* Dietary treatment with or without additional motivation on more physical activity<br>|
| Active Comparator: Physical activity + Dietary treatment<br>pedometers have to be used throughout all days; daily amount of steps is reported via App or website; 10000 steps are defined as daily goal additionally, subjects will be provided with one healthy muffin per day (450 kcal; low GI, high load of PUFA and isomaltulose) over 6 weeks | Behavioral: Lifestyle intervention (physical activity)<br>* Dietary treatment with or without additional motivation on more physical activity<br>Dietary Supplement: Lifestyle intervention (PUFA/isomaltulose-enriched muffin)<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in lipidome pattern | complex human lipidome (blood levels of several hundreds of lipid species) will be assessed before and after intervention | 6 weeks | 
| reduction of blood pressure | systolic and diastolic blood pressure | 6 weeks | 
| NAFLD reduction | NAFLD, estimated by fatty liver index (FLI) | 6 weeks | 
| weight loss | loss in body weight / BMI | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction of insulin resistance | assessed by oral glucose tolerance test, glucose and insulin levels; IS indices (Matsuda, IGI etc.) | 6 weeks | 
| improvement in quality of life | standardized questionnaires | 6 weeks |