Effects of Short-term Interventions for a Healthy Lifestyle on the Human Lipidome in Subjects With Metabolic Syndrome
- Conditions
- ObesityMetabolic SyndromeNAFLDHypertension
- Interventions
- Behavioral: Lifestyle intervention (physical activity)Dietary Supplement: Lifestyle intervention (PUFA/isomaltulose-enriched muffin)
- Registration Number
- NCT03047655
- Lead Sponsor
- German Institute of Human Nutrition
- 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).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- hypertension
- NAFLD
- obesity
- hyperuricemia
- dyslipoproteinemia
- prediabetes / overt diabetes mellitus
- present cancer
- systemic infection
- chronic inflammatory disease
- recent stroke / myocardial infarction (6 months)
- pregnancy
- addiction / severe psychiatric diseases
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Physical activity only Lifestyle intervention (physical activity) 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 Physical activity + Dietary treatment Lifestyle intervention (physical activity) 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 Physical activity + Dietary treatment Lifestyle intervention (PUFA/isomaltulose-enriched muffin) 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
- Primary Outcome Measures
Name Time Method reduction of blood pressure 6 weeks systolic and diastolic blood pressure
change in lipidome pattern 6 weeks complex human lipidome (blood levels of several hundreds of lipid species) will be assessed before and after intervention
NAFLD reduction 6 weeks NAFLD, estimated by fatty liver index (FLI)
weight loss 6 weeks loss in body weight / BMI
- Secondary Outcome Measures
Name Time Method improvement in quality of life 6 weeks standardized questionnaires
reduction of insulin resistance 6 weeks assessed by oral glucose tolerance test, glucose and insulin levels; IS indices (Matsuda, IGI etc.)
Trial Locations
- Locations (2)
German Institut for Human Nutrition; Department for Clinical Nutrition
🇩🇪Bergholz-Rehbrücke, Brandenburg, Germany
DIfE (German Institute for Human Nutrition)
🇩🇪Berlin, Germany