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Fructose Consumption and Metabolic Dysregulation

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ClinicalTrials.gov Identifier: NCT01445730
Recruitment Status : Completed
First Posted : October 4, 2011
Results First Posted : June 15, 2021
Last Update Posted : June 15, 2021
Sponsor:
Collaborators:
Sahlgrenska University Hospital, Sweden
Lund University
University of Naples
Laval University
Information provided by (Responsible Party):
Marja-Riitta Taskinen, Helsinki University Central Hospital

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Central Obesity Hypertriglyceridemia Dietary Supplement: Fructose Not Applicable

Detailed Description:

Detailed description: Study subjects will participate to studies 1-4 before and 3 m after fructose diet:

  1. An oral fat load or a kinetic study with stable isotopes combined with an oral fat load.
  2. Determination of liver, subcutaneous and intra-abdominal fat. (Proton magnetic resonance spectroscopy )
  3. Lipolytic enzymes, advanced lipid analysis, fat biopsies and genetic studies and gut microbiota profiling
  4. Oral glucose tolerance test and analysis of incretins and inflammatory biomarkers.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: N/A
Intervention Model: Single Group 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

Resource links provided by the National Library of Medicine

Drug Information available for: Fructose

Arms and Interventions
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Arm Intervention/treatment
Experimental: After fructose feeding
After 3 month fructose diet 75 g/day
 Dietary Supplement: Fructose
3 month fructose diet 75 g/day


Outcome Measures
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Primary Outcome Measures :
  1. TG Plasma AUC [ Time Frame: Form the baseline (time point 1) to end of treatment at 3 months (time point 2) ]
    Before vs. after fructose challenge: Triglycerides (TG) plasma Area Under Curve (AUC)

  2. B48 Plasma AUC [ Time Frame: Form the baseline (time point 1) to end of treatment at 3 months (time point 2) ]
    Before vs. after fructose challenge: apolipoprotein (apo)B48 plasma Area Under Curve (AUC)

  3. TG Plasma iAUC [ Time Frame: Form the baseline (time point 1) to end of treatment at 3 months (time point 2) ]
    Before vs. after fructose challenge:Triglycerides (TG) plasma incremental Area Under Curve (iAUC)


Secondary Outcome Measures :
  1. DNL [ Time Frame: Form the baseline (time point 1) to end of treatment at 3 months (time point 2) ]
    Before vs. after fructose challenge: de novo lipogenesis (DNL)

  2. ApoC-III [ Time Frame: Form the baseline (time point 1) to end of treatment at 3 months (time point 2) ]
    Before vs. after fructose challenge: Apolipoprotein C-III (ApoC-III)

  3. β-OH Butyrate [ Time Frame: Form the baseline (time point 1) to end of treatment at 3 months (time point 2) ]
    Before vs. after fructose challenge: beta-OH butyrate (β-OH butyrate)

  4. Liver Fat [ Time Frame: Form the baseline (time point 1) to end of treatment at 3 months (time point 2) ]
    Before vs. after fructose challenge


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes 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
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Information from the National Library of Medicine

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


Locations
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Canada
Université Laval
Québec, Canada
Finland
Helsinki University Central Hospital, Biomedicum
Helsinki, Finland, 00290
Italy
University of Naples, Federico II, and Faculty of Medicine
Naples, Italy
Sweden
Sahlgrenska Academy at University of Gothenburg and Sahlgrenska University Hospital
Gothenburg, Sweden
Sponsors and Collaborators
Marja-Riitta Taskinen
Sahlgrenska University Hospital, Sweden
Lund University
University of Naples
Laval University
Investigators
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Principal Investigator: Marja-Riitta Taskinen, Professor Helsinki University Central Hospital, Biomedicum
  Study Documents (Full-Text)

Documents provided by Marja-Riitta Taskinen, Helsinki University Central Hospital:
Study Protocol  [PDF] August 26, 2013

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Marja-Riitta Taskinen, Professor, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT01445730    
Other Study ID Numbers: T1010K0029
First Posted: October 4, 2011    Key Record Dates
Results First Posted: June 15, 2021
Last Update Posted: June 15, 2021
Last Verified: May 2021
Keywords provided by Marja-Riitta Taskinen, Helsinki University Central Hospital:
fructose
hypertriglyceridemia
postprandial lipids
de novo lipogenesis
stable isotopes
Additional relevant MeSH terms:
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Hypertriglyceridemia
Obesity, Abdominal
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
 Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight