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| Name | Class |
|---|---|
| Sahlgrenska University Hospital | OTHER |
| Lund University | OTHER |
| University of Naples | OTHER |
| Laval University |
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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: Study subjects will participate to studies 1-4 before and 3 m after fructose diet:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| After fructose feeding | Experimental | After 3 month fructose diet 75 g/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fructose | Dietary Supplement | 3 month fructose diet 75 g/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| 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) |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| ApoC-III | Before vs. after fructose challenge: Apolipoprotein C-III (ApoC-III) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marja-Riitta Taskinen, Professor | Helsinki University Central Hospital, Biomedicum | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Université Laval | Québec | Canada | ||||
| Helsinki University Central Hospital, Biomedicum |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36040803 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | After Fructose Feeding | After 3 month fructose diet 75 g/day |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Of the 82 subjects, two subjects discontinued the intervention study: one developed a skin rash, which was considered as possible allergic reaction to flavouring and the other subject discontinued in response to his dentist's advice. In addition, the data from magnetic resonance examinations at baseline or after the fructose intervention were not sufficient from nine subjects for technical reasons to allow the analyses of different fat depots. Thus, 71 subjects completed the full study protocol.
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| ID | Title | Description |
|---|---|---|
| BG000 | After Fructose Feeding | After 3 month fructose diet 75 g/day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | TG Plasma AUC | Before vs. after fructose challenge: Triglycerides (TG) plasma Area Under Curve (AUC) | Posted | Mean | Standard Deviation | mmol/l*min | Form the baseline (time point 1) to end of treatment at 3 months (time point 2) |
|
|
During 3 month fructose diet 75 g/day.
Of the 82 subjects, two subjects discontinued the intervention study: one developed a skin rash, which was considered as possible allergic reaction to flavouring and the other subject discontinued in response to his dentist's advice. In addition, the data from magnetic resonance examinations at baseline or after the fructose intervention were not sufficient from nine subjects for technical reasons to allow the analyses of different fat depots. Thus, 71 subjects completed the full study protocol.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | After Fructose Feeding | After 3 month fructose diet 75 g/day | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| skin rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment | One subject developed a skin rash which was considered as possible allergic reaction to flavouring. The rash disappeared after the discontinuation. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Marja-Riitta Taskinen | Helsinki University and Helsinki University Hospital | +358-9-4717 1990 | marja-riitta.taskinen@helsinki.fi |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 26, 2013 | May 19, 2021 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D056128 | Obesity, Abdominal |
| D015228 | Hypertriglyceridemia |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D005632 | Fructose |
| ID | Term |
|---|---|
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
| D007661 |
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| OTHER |
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| 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) | Form the baseline (time point 1) to end of treatment at 3 months (time point 2) |
| Liver Fat | Before vs. after fructose challenge | Form the baseline (time point 1) to end of treatment at 3 months (time point 2) |
| Helsinki |
| 00290 |
| Finland |
| University of Naples, Federico II, and Faculty of Medicine | Naples | Italy |
| Sahlgrenska Academy at University of Gothenburg and Sahlgrenska University Hospital | Gothenburg | Sweden |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | B48 Plasma AUC | Before vs. after fructose challenge: apolipoprotein (apo)B48 plasma Area Under Curve (AUC) | Posted | Mean | Standard Deviation | mg/l*min | 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) | Posted | Mean | Standard Deviation | mmol/l*min | 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) | Posted | Mean | Standard Deviation | μmol/L | 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) | Posted | Mean | Standard Deviation | mg/dL | Form the baseline (time point 1) to end of treatment at 3 months (time point 2) |
|
|
|
|
| Secondary | β-OH Butyrate | Before vs. after fructose challenge: beta-OH butyrate (β-OH butyrate) | Posted | Mean | Standard Deviation | mg/dL | Form the baseline (time point 1) to end of treatment at 3 months (time point 2) |
|
|
|
|
| Secondary | Liver Fat | Before vs. after fructose challenge | Posted | Mean | Standard Deviation | percentage of liver fat content | Form the baseline (time point 1) to end of treatment at 3 months (time point 2) |
|
|
|
|
| 82 |
| 0 |
| 82 |
| 1 |
| 82 |
|
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| Ketoses |