NCT03047655

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

January 9, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 9, 2017

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

June 24, 2020

Status Verified

June 1, 2020

Enrollment Period

4.6 years

First QC Date

November 21, 2016

Last Update Submit

June 23, 2020

Conditions

Metabolic SyndromeNAFLDObesityHypertension

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (2)

  • reduction of insulin resistance

    6 weeks

  • improvement in quality of life

    6 weeks

Study Arms (2)

Physical activity only

ACTIVE COMPARATOR

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)

Physical activity + Dietary treatment

ACTIVE COMPARATOR

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

Interventions

Lifestyle intervention (physical activity)BEHAVIORAL

Dietary treatment with or without additional motivation on more physical activity

Physical activity + Dietary treatmentPhysical activity only
Lifestyle intervention (PUFA/isomaltulose-enriched muffin)DIETARY_SUPPLEMENT
Physical activity + Dietary treatment

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • hypertension
  • NAFLD
  • obesity
  • hyperuricemia
  • dyslipoproteinemia

You may not qualify if:

  • prediabetes / overt diabetes mellitus
  • present cancer
  • systemic infection
  • chronic inflammatory disease
  • recent stroke / myocardial infarction (6 months)
  • pregnancy
  • addiction / severe psychiatric diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

German Institut for Human Nutrition; Department for Clinical Nutrition

Bergholz-Rehbrücke, Brandenburg, 14458, Germany

NOT YET RECRUITING

DIfE (German Institute for Human Nutrition)

Berlin, 12203, Germany

RECRUITING

MeSH Terms

Conditions

Metabolic SyndromeNon-alcoholic Fatty Liver DiseaseObesityHypertension

Interventions

Exercise

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesFatty LiverLiver DiseasesDigestive System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Stefan Kabisch, Dr.med.

CONTACT

030 450 514 429stefan.kabisch@dife.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director (Dpt. Clinical Nutrition)

Study Record Dates

First Submitted

November 21, 2016

First Posted

February 9, 2017

Study Start

January 9, 2017

Primary Completion

August 1, 2021

Study Completion

August 1, 2021

Last Updated

June 24, 2020

Record last verified: 2020-06

Locations

DE(2)