Central ObesityNCT01445730
Fructose Consumption and Metabolic Dysregulation
A study testing Fructose in people with Central Obesity and Hypertriglyceridemia, run by Marja-Riitta Taskinen at 4 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 20 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Central Obesity, Hypertriglyceridemia
- What is being tested?
- Fructose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Aug 2011to Jun 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index 27-40
- Waist > 96 cm
- Age 20-60 years
- Male
Who cannot join
- Smoking
- Active health problems
- Contraindications to MRI scanning
- Bleeding tendency
- Abnormal liver or renal function tests
- Type 2 diabetes
Show all 9Show fewer
- Evidence of metabolic or viral liver disease
- Alcohol intake > 21 units per week
- Chronic medication except ones needed for stable hypertension
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Finland1 site
Helsinki University Central Hospital, Biomedicum
Helsinki, 00290
Sweden1 site
Sahlgrenska Academy at University of Gothenburg and Sahlgrenska University Hospital
Gothenburg
About this study
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
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.
Read the detailed description
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.
- Conditions
- Central Obesity, Hypertriglyceridemia
- Being tested
- Fructose
- Keywords
- fructose, hypertriglyceridemia, postprandial lipids, de novo lipogenesis, stable isotopes
- Medical subject headings
- Obesity, Abdominal, Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FructoseDietary supplement
3 month fructose diet 75 g/day
| Study group | Role | What they receive |
|---|---|---|
| After fructose feeding | Experimental | After 3 month fructose diet 75 g/day Receives: Dietary Supplement: Fructose |
What is being measured
The primary outcome is the main question the study is designed to answer.
TG Plasma AUC
Before vs. after fructose challenge: Triglycerides (TG) plasma Area Under Curve (AUC)
Measured: Form the baseline (time point 1) to end of treatment at 3 months (time point 2)
B48 Plasma AUC
Before vs. after fructose challenge: apolipoprotein (apo)B48 plasma Area Under Curve (AUC)
Measured: Form the baseline (time point 1) to end of treatment at 3 months (time point 2)
TG Plasma iAUC
Before vs. after fructose challenge:Triglycerides (TG) plasma incremental Area Under Curve (iAUC)
Measured: Form the baseline (time point 1) to end of treatment at 3 months (time point 2)
Secondary outcomes (4)
DNL
Before vs. after fructose challenge: de novo lipogenesis (DNL)
Measured: Form the baseline (time point 1) to end of treatment at 3 months (time point 2)
ApoC-III
Before vs. after fructose challenge: Apolipoprotein C-III (ApoC-III)
Measured: Form the baseline (time point 1) to end of treatment at 3 months (time point 2)
β-OH Butyrate
Before vs. after fructose challenge: beta-OH butyrate (β-OH butyrate)
Measured: Form the baseline (time point 1) to end of treatment at 3 months (time point 2)
Liver Fat
Before vs. after fructose challenge
Measured: Form the baseline (time point 1) to end of treatment at 3 months (time point 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2011 (estimated)
- Study startAug 2011
- Primary completionMay 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Central ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marja-Riitta Taskinen
- Sponsor type
- University, hospital or other
- Collaborators
- Sahlgrenska University Hospital, Lund University, University of Naples, Laval University
- Responsible party
- Sponsor-investigator, Marja-Riitta Taskinen, Helsinki University Central Hospital
- Investigators
- Marja-Riitta Taskinen, Professor, Principal investigator, Helsinki University Central Hospital, Biomedicum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01445730
- Sponsor's protocol ID
- T1010K0029
- Status last verified
- May 2021
- First submitted
- 28 Sep 2011
- Last updated
- 15 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 36040803
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01445730
- Acronym / sponsor ID
- T1010K0029
- Conditions
- Central Obesity, Hypertriglyceridemia
- Keywords
- fructose, hypertriglyceridemia, postprandial lipids, de novo lipogenesis, stable isotopes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Marja-Riitta TaskinenUniversity, hospital or other
- Collaborators
- Sahlgrenska University Hospital, Lund University, University of Naples, Laval University
- Study start
- Aug 2011
- Primary completion
- May 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 4 Oct 2011 (estimated)
- Results
- Posted 15 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| After fructose feeding | Experimental | Dietary Supplement: FructoseAfter 3 month fructose diet 75 g/day |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Body mass index 27-40
- Waist > 96 cm
- Age 20-60 years
- Male
Key exclusion criteria (9 listed)
- Smoking
- Active health problems
- Contraindications to MRI scanning
- Bleeding tendency
- Abnormal liver or renal function tests
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fructose3 month fructose diet 75 g/day | Dietary supplement | After fructose feeding |
Primary outcome
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)
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)
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)
4 secondary outcomes
DNL
Time frame: Form the baseline (time point 1) to end of treatment at 3 months (time point 2)
ApoC-III
Time frame: Form the baseline (time point 1) to end of treatment at 3 months (time point 2)
β-OH Butyrate
Time frame: Form the baseline (time point 1) to end of treatment at 3 months (time point 2)
Liver Fat
Time frame: Form the baseline (time point 1) to end of treatment at 3 months (time point 2)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36040803Taskinen 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.
Related trials for Central Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
Active, not recruiting
Influence of FreeO2 on Percentage of Time Within Oxygen Saturation Target Using Noninvasive Ventilation (NIV) and Continuous Positive Airway Pressure (CPAP) for Patients Admitted for AECOPD or Bariatric Surgery
COPD Exacerbation, Oxygen Toxicity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marja-Riitta Taskinen, Professor principal investigator
Helsinki University Central Hospital, Biomedicum
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fructose in people with Central Obesity and Hypertriglyceridemia, run by Marja-Riitta Taskinen at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada, Finland, Italy, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TG Plasma AUC (time frame: Form the baseline (time point 1) to end of treatment at 3 months (time point 2)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01445730, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2021.