POLY-unsaturated Fatty Acids in the Preservation of Dietary Effects on Hepatosteatosis and Energy Metabolism in Type 2 Diabetes
NCT ID: NCT03047668
Last Updated: 2020-07-22
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
200 participants
INTERVENTIONAL
2013-05-31
2020-12-31
Brief Summary
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The researchers therefore investigate dietary strategies such as low-carb and very-low calory diets regarding their potential to improve metabolism and body weight in (mostly) long-term T2DM patients. This core comparison is dealt with in the DiNA-D study (published elsewhere).
POLYPHEM targets specific dietary approach to preserve the achieved metabolic improvements from DiNA-D phase 1. Nutritional factors will be PUFAs and BCAAs.
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Detailed Description
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The researchers therefore investigate dietary strategies such as low-carb and very-low calory diets regarding their potential to improve metabolism and body weight in (mostly) long-term T2DM patients. This core comparison is dealt with in the DiNA-D study (published elsewhere).
POLYPHEM targets specific dietary approach to preserve the achieved metabolic improvements from DiNA-D phase 1. Nutritional factors for the maintenance period within DiNA-D (11 months) will be PUFAs and BCAAs, provided by walnuts and custom-made muffins containing walnuts, sunflower oil and isomaltulose.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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low-carb with PUFA
49 weeks of hypo- to isocaloric low-carb diet (\< 40 EI% carbs), amplified with walnuts and walnut-sunflower muffins
diet with/without supplementation
diet with/without supplementation with PUFAs
low-carb without PUFA
49 weeks of hypo- to isocaloric low-carb diet (\< 40 EI% carbs), without walnuts / walnut-sunflower muffins
diet with/without supplementation
diet with/without supplementation with PUFAs
low-fat with PUFA
49 weeks of hypo- to isocaloric low-fat diet (\< 30 EI% fat), amplified with walnuts and walnut-sunflower muffins
diet with/without supplementation
diet with/without supplementation with PUFAs
low-fat without PUFA
49 weeks of hypo- to isocaloric low-fat diet (\< 30 EI% fat), without walnuts / walnut-sunflower muffins
diet with/without supplementation
diet with/without supplementation with PUFAs
Interventions
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diet with/without supplementation
diet with/without supplementation with PUFAs
Eligibility Criteria
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Inclusion Criteria
* 18-79 years old
* type 2 diabetes
Exclusion Criteria
* anaemia
* immunosuppression
* previous symptomatic cancer diagnosis
* acute cardiovascular disease (stroke, coronary syndrome)
* pregnancy and lactation
* severe psychiatric disorders
* corticoid or other immunosuppressive therapy
18 Years
79 Years
ALL
No
Sponsors
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German Center for Diabetes Research
OTHER
California Walnut Commission
OTHER
Institute for Cereal Processing GmbH/Institut für Getreideverarbeitung (IGV)
UNKNOWN
German Institute of Human Nutrition
OTHER
Responsible Party
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Prof. Dr. med. Andreas F. H. Pfeiffer
PI
Principal Investigators
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Andreas FH Pfeiffer, Prof. Dr. med.
Role: PRINCIPAL_INVESTIGATOR
DIfE
Locations
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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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POLYPHEM
Identifier Type: -
Identifier Source: org_study_id
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