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

Obesity Clinical Trial

— GesundLeben  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03047655
• Other study ID #: GesundLeben
• Status: Recruiting
• Phase: N/A
• Start date: January 9, 2017
• Est. completion date: August 2021

Study information

• Verified date: June 2020
• Source: German Institute of Human Nutrition
• Contact: Stefan Kabisch, Dr.med.
• Phone: 030 450 514 429
• Email: stefan.kabisch[@]dife.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Metabolic Syndrome
• NAFLD
• Obesity
• Syndrome

Intervention

Behavioral:
• Lifestyle intervention (physical activity)
Dietary treatment with or without additional motivation on more physical activity

Dietary Supplement:
• Lifestyle intervention (PUFA/isomaltulose-enriched muffin)

Locations

Country	Name	City	State
Germany	German Institut for Human Nutrition; Department for Clinical Nutrition	Bergholz-Rehbrücke	Brandenburg
Germany	DIfE (German Institute for Human Nutrition)	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
German Institute of Human Nutrition

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in lipidome pattern	complex human lipidome (blood levels of several hundreds of lipid species) will be assessed before and after intervention	6 weeks
Primary	reduction of blood pressure	systolic and diastolic blood pressure	6 weeks
Primary	NAFLD reduction	NAFLD, estimated by fatty liver index (FLI)	6 weeks
Primary	weight loss	loss in body weight / BMI	6 weeks
Secondary	reduction of insulin resistance	assessed by oral glucose tolerance test, glucose and insulin levels; IS indices (Matsuda, IGI etc.)	6 weeks
Secondary	improvement in quality of life	standardized questionnaires	6 weeks