NCT03047655

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: German Institute of Human Nutrition · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	Lifestyle intervention (physical activity)	Dietary treatment with or without additional motivation on more physical activity
DIETARY_SUPPLEMENT	Lifestyle intervention (PUFA/isomaltulose-enriched muffin)

Timeline

• Start date: 2017-01-09
• Primary completion: 2021-08-01
• Completion: 2021-08-01
• First posted: 2017-02-09
• Last updated: 2020-06-24

Locations

2 sites across 1 country: Germany