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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01445730
Other study ID # T1010K0029
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2011
Est. completion date June 2015

Study information

Verified date May 2021
Source Helsinki University Central Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 82
Est. completion date June 2015
Est. primary completion date May 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Fructose
3 month fructose diet 75 g/day

Locations

Country Name City State
Canada Université Laval Québec
Finland Helsinki University Central Hospital, Biomedicum Helsinki
Italy University of Naples, Federico II, and Faculty of Medicine Naples
Sweden Sahlgrenska Academy at University of Gothenburg and Sahlgrenska University Hospital Gothenburg

Sponsors (5)

Lead Sponsor Collaborator
Marja-Riitta Taskinen Laval University, Lund University, Sahlgrenska University Hospital, Sweden, University of Naples

Countries where clinical trial is conducted

Canada,  Finland,  Italy,  Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary TG Plasma AUC Before vs. after fructose challenge: Triglycerides (TG) plasma Area Under Curve (AUC) Form the baseline (time point 1) to end of treatment at 3 months (time point 2)
Primary B48 Plasma AUC Before vs. after fructose challenge: apolipoprotein (apo)B48 plasma Area Under Curve (AUC) Form the baseline (time point 1) to end of treatment at 3 months (time point 2)
Primary TG Plasma iAUC Before vs. after fructose challenge:Triglycerides (TG) plasma incremental Area Under Curve (iAUC) Form the baseline (time point 1) to end of treatment at 3 months (time point 2)
Secondary DNL Before vs. after fructose challenge: de novo lipogenesis (DNL) Form the baseline (time point 1) to end of treatment at 3 months (time point 2)
Secondary ApoC-III Before vs. after fructose challenge: Apolipoprotein C-III (ApoC-III) Form the baseline (time point 1) to end of treatment at 3 months (time point 2)
Secondary ß-OH Butyrate Before vs. after fructose challenge: beta-OH butyrate (ß-OH butyrate) Form the baseline (time point 1) to end of treatment at 3 months (time point 2)
Secondary Liver Fat Before vs. after fructose challenge Form the baseline (time point 1) to end of treatment at 3 months (time point 2)
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