Skip to main content
OpenTrials
Completed

NCT Number: NCT01445730

Fructose Consumption and Metabolic Dysregulation

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Central Obesity Body Weight Dyslipidemias Hyperlipidemias Hypertriglyceridemia Lipid Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Abdominal Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Université Laval, Québec, Canada

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fructose

Dietary Supplement

3 month fructose diet 75 g/day

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Marja-Riitta Taskinen

Other

Collaborators

  • Laval University
  • Lund University
  • Sahlgrenska University Hospital
  • University of Naples

Registry information

Official study title

Fructose Consumption Aggravates Dysregulation of Postprandial Lipid Metabolism in Obese Hypertriglyceridemic Men With High Cardiometabolic Risk Profile and Associates With Liver Fat Deposition

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Oct 4, 2011
Registry last updated
Jun 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.