Effects of Short-term Interventions for a Healthy Lifestyle on the Human Lipidome in Subjects With Metabolic Syndrome
NCT ID: NCT03047655
Last Updated: 2020-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2017-01-09
2021-08-31
Brief Summary
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"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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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
Lifestyle intervention (physical activity)
Dietary treatment with or without additional motivation on more physical activity
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
Lifestyle intervention (physical activity)
Dietary treatment with or without additional motivation on more physical activity
Lifestyle intervention (PUFA/isomaltulose-enriched muffin)
Interventions
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Lifestyle intervention (physical activity)
Dietary treatment with or without additional motivation on more physical activity
Lifestyle intervention (PUFA/isomaltulose-enriched muffin)
Eligibility Criteria
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Inclusion Criteria
* NAFLD
* obesity
* hyperuricemia
* dyslipoproteinemia
Exclusion Criteria
* present cancer
* systemic infection
* chronic inflammatory disease
* recent stroke / myocardial infarction (6 months)
* pregnancy
* addiction / severe psychiatric diseases
18 Years
75 Years
ALL
No
Sponsors
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German Institute of Human Nutrition
OTHER
Responsible Party
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Prof. Dr. med. Andreas F. H. Pfeiffer
Director (Dpt. Clinical Nutrition)
Locations
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German Institut for Human Nutrition; Department for Clinical Nutrition
Bergholz-Rehbrücke, Brandenburg, Germany
DIfE (German Institute for Human Nutrition)
Berlin, , Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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GesundLeben
Identifier Type: -
Identifier Source: org_study_id
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