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

Primary Purpose

Metabolic Syndrome, NAFLD, Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Lifestyle intervention (physical activity)
Lifestyle intervention (PUFA/isomaltulose-enriched muffin)
Sponsored by
German Institute of Human Nutrition
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Syndrome

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • German Institut for Human Nutrition; Department for Clinical Nutrition
  • DIfE (German Institute for Human Nutrition)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Physical activity only

Physical activity + Dietary treatment

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

reduction of insulin resistance
assessed by oral glucose tolerance test, glucose and insulin levels; IS indices (Matsuda, IGI etc.)
improvement in quality of life
standardized questionnaires

Full Information

First Posted
November 21, 2016
Last Updated
June 23, 2020
Sponsor
German Institute of Human Nutrition
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1. Study Identification

Unique Protocol Identification Number
NCT03047655
Brief Title
Effects of Short-term Interventions for a Healthy Lifestyle on the Human Lipidome in Subjects With Metabolic Syndrome
Acronym
GesundLeben
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 9, 2017 (Actual)
Primary Completion Date
August 2021 (Anticipated)
Study Completion Date
August 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
German Institute of Human Nutrition

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, NAFLD, Obesity, Hypertension

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Physical activity only
Arm Type
Active Comparator
Arm Description
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
Arm Title
Physical activity + Dietary treatment
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle intervention (physical activity)
Intervention Description
Dietary treatment with or without additional motivation on more physical activity
Intervention Type
Dietary Supplement
Intervention Name(s)
Lifestyle intervention (PUFA/isomaltulose-enriched muffin)
Primary Outcome Measure Information:
Title
change in lipidome pattern
Description
complex human lipidome (blood levels of several hundreds of lipid species) will be assessed before and after intervention
Time Frame
6 weeks
Title
reduction of blood pressure
Description
systolic and diastolic blood pressure
Time Frame
6 weeks
Title
NAFLD reduction
Description
NAFLD, estimated by fatty liver index (FLI)
Time Frame
6 weeks
Title
weight loss
Description
loss in body weight / BMI
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
reduction of insulin resistance
Description
assessed by oral glucose tolerance test, glucose and insulin levels; IS indices (Matsuda, IGI etc.)
Time Frame
6 weeks
Title
improvement in quality of life
Description
standardized questionnaires
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stefan Kabisch, Dr.med.
Phone
030 450 514 429
Email
stefan.kabisch@dife.de
Facility Information:
Facility Name
German Institut for Human Nutrition; Department for Clinical Nutrition
City
Bergholz-Rehbrücke
State/Province
Brandenburg
ZIP/Postal Code
14458
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margrit Kemper, Dr. med.
Phone
033200 88 2775
Email
margrit.kemper@dife.de
First Name & Middle Initial & Last Name & Degree
Silke Hornemann
Phone
033200 88 2779
Email
silke.hornemann@dife.de
First Name & Middle Initial & Last Name & Degree
Margrit Kemper, Dr. med.
First Name & Middle Initial & Last Name & Degree
Silke Hornemann
First Name & Middle Initial & Last Name & Degree
Christiana Gerbracht, Dr.
Facility Name
DIfE (German Institute for Human Nutrition)
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan Kabisch, Dr. med.
Phone
030 450 514 429
Email
stefan.kabisch@dife.de

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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