This trial is active, not recruiting.

Conditions central obesity, hypertriglyceridemia
Treatments fructose
Sponsor Marja-Riitta Taskinen
Collaborator Sahlgrenska University Hospital, Sweden
Start date August 2011
End date May 2015
Trial size 128 participants
Trial identifier NCT01445730, T1010K0029


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose basic science
1. TG ≤1.7 mmo/l 2. TG > 1.7 mmol/l
fructose drink 75 g/day per day while consuming a self-selected ad libitum diet
(Active Comparator)
3. TG ≤1.7 mmo/l 4. TG > 1.7 mmol/l
3 month fructose diet 75 g/day while consuming isocaloric diet

Primary Outcomes

Plasma Triglyceride (TG) area under curve (AUC)
time frame: 3 months
Very low density lipoprotein 1 (VLDL1) apolipoprotein B-100 (ApoB-100) kinetics
time frame: 3 months
VLDL1 ApoB-100 kinetics
time frame: 3 months

Secondary Outcomes

Metabolic parameters
time frame: 3 months
Metabolic parameters
time frame: 3 months
Metabolic parameters
time frame: 3 months
Metabolic parameters
time frame: 3 months
Metabolic parameters
time frame: 3 months
Metabolic parameters
time frame: 3 months

Eligibility Criteria

Male participants from 20 years up to 60 years old.

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

Additional Information

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
Principal investigator Marja-Riitta Taskinen, Professor
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Helsinki University Central Hospital.