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

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.

Study Overview

• Status: Unknown
• Conditions: Hypertension; Obesity; Metabolic Syndrome; NAFLD
• Intervention / Treatment: Behavioral: Lifestyle intervention (physical activity); Dietary supplement: Lifestyle intervention (PUFA/isomaltulose-enriched muffin)

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).

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stefan Kabisch, Dr.med.; Phone Number: 030 450 514 429; Email: stefan.kabisch@dife.de

Study Locations

• Germany
  • Berlin, Germany, 12203
    • Recruiting
    • DIfE (German Institute for Human Nutrition)
  • Brandenburg
    • Bergholz-Rehbrücke, Brandenburg, Germany, 14458
      • Not yet recruiting
      • German Institut for Human Nutrition; Department for Clinical Nutrition
      • Contact: Margrit Kemper, Dr. med.; Phone Number: 033200 88 2775; Email: margrit.kemper@dife.de
      • Contact: Silke Hornemann; Phone Number: 033200 88 2779; Email: silke.hornemann@dife.de
      • Sub-Investigator: Margrit Kemper, Dr. med.
      • Sub-Investigator: Silke Hornemann
      • Sub-Investigator: Christiana Gerbracht, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Physical activity only; 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); Dietary treatment with or without additional motivation on more physical activity
Active Comparator: Physical activity + Dietary treatment; 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); Dietary treatment with or without additional motivation on more physical activity; Dietary supplement: Lifestyle intervention (PUFA/isomaltulose-enriched muffin)

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

Collaborators and Investigators

• Sponsor: German Institute of Human Nutrition

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2017
• Primary Completion (Anticipated): August 1, 2021
• Study Completion (Anticipated): August 1, 2021

Study Registration Dates

• First Submitted: November 21, 2016
• First Submitted That Met QC Criteria: February 6, 2017
• First Posted (Estimate): February 9, 2017

Study Record Updates

• Last Update Posted (Actual): June 24, 2020
• Last Update Submitted That Met QC Criteria: June 23, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: GesundLeben

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED