Fructose Consumption and Metabolic Dysregulation
This study is currently recruiting participants.
Verified October 2011 by Helsinki University Central Hospital
Sponsor:
Marja-Riitta Taskinen
Collaborators:
Sahlgrenska University Hospital, Sweden
Lund University
University of Naples
Laval University
Information provided by (Responsible Party):
Marja-Riitta Taskinen, Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT01445730
First received: September 28, 2011
Last updated: October 4, 2011
Last verified: October 2011
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Purpose
High fructose intake is increasingly recognized as causative in development of prediabetes, metabolic syndrome and cardiovascular disease (CVD). The mechanisms underlying fructose-induced metabolic disturbances are unclear but are beginning to be unraveled. In contrast to metabolism of glucose, the breakdown of fructose leads to the generation of metabolites that stimulate hepatic de novo lipogenesis (DNL) and increased levels of both fasting and postprandial triglycerides. The key lipogenic transcription factor seems to be activated by fructose independently of insulin. However, it is still controversial whether fructose consumption increases DNL in man to the extent that it induces metabolic disturbances. Animal studies have shown that also the adipose tissue is responsive to fructose feeding fructose, and that high fructose-feeding induces insulin resistance and inflammation in the adipose tissue. The role of intestinal insulin resistance in fructose-induced dysmetabolism has not been studied in detail. The critical question is whether the metabolic disturbances are induced by calorie excess or by fructose per se.
| Condition | Intervention |
|---|---|
|
Central Obesity Hypertriglyceridemia |
Dietary Supplement: Fructose |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Helsinki University Central Hospital:
Primary Outcome Measures:
- Plasma Triglyceride (TG) area under curve (AUC) [ Time Frame: 3 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Before vs. after fructose challenge: VLDL1 ApoB-100 secretion rate.
- VLDL1 ApoB-100 kinetics [ Time Frame: 3 months ] [ Designated as safety issue: No ]VLDL1 ApoB-100 catabolic rate
Secondary Outcome Measures:
- Metabolic parameters [ Time Frame: 3 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Before vs. after fructose challenge: Hepatic DNL
- Metabolic parameters [ Time Frame: 3 months ] [ Designated as safety issue: No ]Before vs. after fructose challenge: Plasma inflammatory markers
- Metabolic parameters [ Time Frame: 3 months ] [ Designated as safety issue: No ]Before vs. after fructose challenge: Incretin response
- Metabolic parameters [ Time Frame: 3 months ] [ Designated as safety issue: No ]Before vs. after fructose challenge: Plasma and adipose tissue lipidomics /genetics.
- Metabolic parameters [ Time Frame: 3 months ] [ Designated as safety issue: No ]Before vs. after fructose challenge: Gut microbiota profiling.
| Estimated Enrollment: | 128 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 20 Years to 60 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Body mass index 27-40
- Waist > 96 cm
- Age 20-60 years
- Male
Exclusion Criteria:
- Smoking
- Active health problems
- Contraindications to MRI scanning
- Bleeding tendency
- Abnormal liver or renal function tests
- Type 2 diabetes
- Evidence of metabolic or viral liver disease
- Alcohol intake > 21 units per week
- Chronic medication except ones needed for stable hypertension
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01445730
Contacts
| Contact: Niina Matikainen, MD, PhD | +358-94711 |
Locations
| Canada | |
| Université Laval | Recruiting |
| Québec, Canada | |
| Contact: Jean-Pierre Despres, Professor | |
| Finland | |
| Helsinki University Central Hospital, Biomedicum | Recruiting |
| Helsinki, Finland, 00290 | |
| Italy | |
| University of Naples, Federico II, and Faculty of Medicine | Not yet recruiting |
| Naples, Italy | |
| Contact: Angela A Rivellese, Professor | |
| Sweden | |
| Sahlgrenska Academy at University of Gothenburg and Sahlgrenska University Hospital | Recruiting |
| Gothenburg, Sweden | |
| Contact: Björn Eliasson, Adjunct prof | |
Sponsors and Collaborators
Marja-Riitta Taskinen
Sahlgrenska University Hospital, Sweden
Lund University
University of Naples
Laval University
Investigators
| Principal Investigator: | Marja-Riitta Taskinen, Professor | Helsinki University Central Hospital, Biomedicum |
More Information
No publications provided
| Responsible Party: | Marja-Riitta Taskinen, Professor, Helsinki University Central Hospital |
| ClinicalTrials.gov Identifier: | NCT01445730 History of Changes |
| Other Study ID Numbers: | T1010K0029 |
| Study First Received: | September 28, 2011 |
| Last Updated: | October 4, 2011 |
| Health Authority: | Finland: Ethics Committee |
Keywords provided by Helsinki University Central Hospital:
|
fructose hypertriglyceridemia postprandial lipids de novo lipogenesis stable isotopes |
Additional relevant MeSH terms:
|
Hypertriglyceridemia Obesity Obesity, Abdominal Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders |
Metabolic Diseases Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013