Fructose Consumption and Metabolic Dysregulation
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|ClinicalTrials.gov Identifier: NCT01445730|
Recruitment Status : Completed
First Posted : October 4, 2011
Last Update Posted : August 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Central Obesity Hypertriglyceridemia||Dietary Supplement: Fructose||Not Applicable|
Detailed description: Study subjects will participate to studies 1-4 before and 3 m after fructose diet:
- An oral fat load or a kinetic study with stable isotopes combined with an oral fat load.
- Determination of liver, subcutaneous and intra-abdominal fat. (Proton magnetic resonance spectroscopy )
- Lipolytic enzymes, advanced lipid analysis, fat biopsies and genetic studies and gut microbiota profiling
- Oral glucose tolerance test and analysis of incretins and inflammatory biomarkers.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||82 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Fructose Consumption Aggravates Dysregulation of Postprandial Lipid Metabolism in Obese Hypertriglyceridemic Men With High Cardiometabolic Risk Profile and Associates With Liver Fat Deposition|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||June 2015|
Experimental: Hypercaloric fructose diet
1. TG ≤1.7 mmo/l 2. TG > 1.7 mmol/l
Dietary Supplement: Fructose
fructose drink 75 g/day per day while consuming a self-selected ad libitum diet
Active Comparator: Isocaloric fructose diet
3. TG ≤1.7 mmo/l 4. TG > 1.7 mmol/l
Dietary Supplement: Fructose
3 month fructose diet 75 g/day while consuming isocaloric diet
- Plasma Triglyceride (TG) area under curve (AUC) [ Time Frame: 3 months ]Before vs. after fructose challenge: Postprandial plasma TG summary measure expressed as AUC (baseline to 8hours) after oral fat.
- Very low density lipoprotein 1 (VLDL1) apolipoprotein B-100 (ApoB-100) kinetics [ Time Frame: 3 months ]Before vs. after fructose challenge: VLDL1 ApoB-100 secretion rate.
- VLDL1 ApoB-100 kinetics [ Time Frame: 3 months ]VLDL1 ApoB-100 catabolic rate
- Metabolic parameters [ Time Frame: 3 months ]Before vs. after fructose challenge: Postprandial lipids and apolipoproteins (8hours) after oral fat and/or non-steady state kinetic parameters
- Metabolic parameters [ Time Frame: 3 months ]Before vs. after fructose challenge: Hepatic DNL
- Metabolic parameters [ Time Frame: 3 months ]Before vs. after fructose challenge: Plasma inflammatory markers
- Metabolic parameters [ Time Frame: 3 months ]Before vs. after fructose challenge: Incretin response
- Metabolic parameters [ Time Frame: 3 months ]Before vs. after fructose challenge: Plasma and adipose tissue lipidomics /genetics.
- Metabolic parameters [ Time Frame: 3 months ]Before vs. after fructose challenge: Gut microbiota profiling.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01445730
|Helsinki University Central Hospital, Biomedicum|
|Helsinki, Finland, 00290|
|University of Naples, Federico II, and Faculty of Medicine|
|Sahlgrenska Academy at University of Gothenburg and Sahlgrenska University Hospital|
|Principal Investigator:||Marja-Riitta Taskinen, Professor||Helsinki University Central Hospital, Biomedicum|