Fructose Consumption and Metabolic Dysregulation

NCT ID: NCT01445730

Last Updated: 2021-06-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2015-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Central Obesity Hypertriglyceridemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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After fructose feeding

After 3 month fructose diet 75 g/day

Group Type EXPERIMENTAL

Fructose

Intervention Type DIETARY_SUPPLEMENT

3 month fructose diet 75 g/day

Interventions

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Fructose

3 month fructose diet 75 g/day

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sahlgrenska University Hospital

OTHER

Sponsor Role collaborator

Lund University

OTHER

Sponsor Role collaborator

University of Naples

OTHER

Sponsor Role collaborator

Laval University

OTHER

Sponsor Role collaborator

Marja-Riitta Taskinen

OTHER

Sponsor Role lead

Responsible Party

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Marja-Riitta Taskinen

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Marja-Riitta Taskinen, Professor

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital, Biomedicum

Locations

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Université Laval

Québec, , Canada

Site Status

Helsinki University Central Hospital, Biomedicum

Helsinki, , Finland

Site Status

University of Naples, Federico II, and Faculty of Medicine

Naples, , Italy

Site Status

Sahlgrenska Academy at University of Gothenburg and Sahlgrenska University Hospital

Gothenburg, , Sweden

Site Status

Countries

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Canada Finland Italy Sweden

References

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Taskinen MR, Bjornson E, Matikainen N, Soderlund S, Ramo J, Ainola MM, Hakkarainen A, Sihlbom C, Thorsell A, Andersson L, Bergh PO, Henricsson M, Romeo S, Adiels M, Ripatti S, Laakso M, Packard CJ, Boren J. Postprandial metabolism of apolipoproteins B48, B100, C-III, and E in humans with APOC3 loss-of-function mutations. JCI Insight. 2022 Oct 10;7(19):e160607. doi: 10.1172/jci.insight.160607.

Reference Type DERIVED
PMID: 36040803 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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T1010K0029

Identifier Type: -

Identifier Source: org_study_id

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