- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03545581
Fructose Supplementation in Carriers for Hereditary Fructose Intolerance
Metabolic Effects of Short-term Dietary Supplementation With Fructose in Carriers for Hereditary Fructose Intolerance
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A high fructose intake also increases blood lactate and uric acid concentrations. It has been proposed that uric acid may contribute to insulin resistance by impairing endothelium-dependent vasodilation, promoting pro-inflammatory effects and dyslipidemia by activating de novo lipogenesis.
These consequences of fructose overconsumption may be even more marked in individuals with hereditary alterations in fructose metabolism. Indeed, individuals with hereditary fructose intolerance (HFI), due to biallelic mutations in the gene coding for aldolase B (ALDOB), may develop acute, life-threatening manifestations when exposed to fructose. Heterozygous carriers of ALDOB mutation are quite common in the general population, with a predicted frequency ranging between 1:55 and 1:120. Few studies have examined the effect of fructose ingestion in heterozygotes subject for HFI. Heterozygous carriers are generally considered to have normal fructose metabolism since a ~ 50% level of aldolase B activity is presumed to be sufficient for adequate function. However, heterozygous carriers were reported to have enhanced uric acid responses to large intravenous and/or oral fructose loads.
Investigators hypothesized that heterozygous carriers may also have mild defects of fructose metabolism and/or a larger increase in cardiometabolic risk factors than the normal population after ingestion of moderate amounts of fructose.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Liège, Belgium
- Guillaume Debray
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Case subjects: Heterozygous carriers for ALDOB mutation confirmed by molecular analysis
- Control subjects: healthy individuals matched for weight and age to subjects
Exclusion Criteria:
- Fasting glucose > 7.0 mmol/L
- Fasting triglycerides > 4.0 mmol/L
- Chronic renal insufficiency (eGFR < 50 ml/min)
- Drugs
- Women who are pregnant or breast feeding
- For women: lack of safe contraception
- Alcool consumption > 30g/d
- Inability to discern
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Experimental diet Fru rich diet
Enriched fructose diet from day 1 to day 7.
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7 days (day 1 to day 7) with fructose enriched drinks 3x/d.
Test meal at day 7 with fructose (0.7 g/body weight) and glucose (0.7 g/body weight)
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Other: Experimental low Fru diet
Low fructose diet from day 1 to day 7.
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7 days (day 1 to day 7) with low-fructose diet (<10g/d).
Test meal at day 7 with fructose (0.7 g/body weight) and glucose (0.7 g/body weight)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Metabolite concentration
Time Frame: Time Frame: -30 min before ingestion of a test meal to 120 min after ingestion of a test meal
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The primary endpoint is the change of metabolite concentration after ingestion of a test meal (oral glucose and fructose load) under 2 conditions (enriched fructose diet vs poor fructose diet) according to a crossover design
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Time Frame: -30 min before ingestion of a test meal to 120 min after ingestion of a test meal
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma glucose concentration
Time Frame: Time Frame: -30 min before ingestion of a test meal to 120 min after ingestion of a test meal
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Change in glucose concentration after ingestion of a test meal under 2 conditions (enriched fructose diet vs poor fructose diet) according to a crossover design
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Time Frame: -30 min before ingestion of a test meal to 120 min after ingestion of a test meal
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Plasma insulin concentration
Time Frame: Time Frame: -30 min before ingestion of a test meal to 120 min after ingestion of a test meal
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Change in insulin concentration after ingestion of a test meal under 2 conditions (enriched fructose diet vs poor fructose diet) according to a crossover design
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Time Frame: -30 min before ingestion of a test meal to 120 min after ingestion of a test meal
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Plasma fructose concentration
Time Frame: Time Frame: -30 min before ingestion of a test meal to 120 min after ingestion of a test meal
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Change in fructose concentration after ingestion of a test meal under 2 conditions (enriched fructose diet vs poor fructose diet) according to a crossover design
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Time Frame: -30 min before ingestion of a test meal to 120 min after ingestion of a test meal
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Plasma uric acid concentration
Time Frame: Time Frame: -30 min before ingestion of a test meal to 120 min after ingestion of a test meal
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Change in uric acid concentration after ingestion of a test meal under 2 conditions (enriched fructose diet vs poor fructose diet) according to a crossover design
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Time Frame: -30 min before ingestion of a test meal to 120 min after ingestion of a test meal
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Plasma lactate concentration
Time Frame: Time Frame: -30 min before ingestion of a test meal to 120 min after ingestion of a test meal
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Change in lactate concentration after ingestion of a test meal under 2 conditions (enriched fructose diet vs poor fructose diet) according to a crossover design
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Time Frame: -30 min before ingestion of a test meal to 120 min after ingestion of a test meal
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Plasma urea concentration
Time Frame: Time Frame: -30 min before ingestion of a test meal to 120 min after ingestion of a test meal
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Change in urea concentration after ingestion of a test meal under 2 conditions (enriched fructose diet vs poor fructose diet) according to a crossover design
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Time Frame: -30 min before ingestion of a test meal to 120 min after ingestion of a test meal
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Plasma creatinine concentration
Time Frame: Time Frame: -30 min before ingestion of a test meal to 120 min after ingestion of a test meal
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Change in creatinine concentration after ingestion of a test meal under 2 conditions (enriched fructose diet vs poor fructose diet) according to a crossover design
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Time Frame: -30 min before ingestion of a test meal to 120 min after ingestion of a test meal
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Plasma phosphate concentration
Time Frame: Time Frame: -30 min before ingestion of a test meal to 120 min after ingestion of a test meal
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Change in phosphate concentration after ingestion of a test meal under 2 conditions (enriched fructose diet vs poor fructose diet) according to a crossover design
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Time Frame: -30 min before ingestion of a test meal to 120 min after ingestion of a test meal
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Plasma triglycerides concentration
Time Frame: Time Frame: -30 min before ingestion of a test meal to 120 min after ingestion of a test meal
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Change in triglycerides concentration after ingestion of a test meal under 2 conditions (enriched fructose diet vs poor fructose diet) according to a crossover design
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Time Frame: -30 min before ingestion of a test meal to 120 min after ingestion of a test meal
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Plasma metabolome concentration
Time Frame: Time Frame: -30 min before ingestion of a test meal to 120 min after ingestion of a test meal
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Change in metabolome concentration after ingestion of a test meal under 2 conditions (enriched fructose diet vs poor fructose diet) according to a crossover design
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Time Frame: -30 min before ingestion of a test meal to 120 min after ingestion of a test meal
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Plasma ammonia concentration
Time Frame: Time Frame: -30 min before ingestion of a test meal to 120 min after ingestion of a test meal
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Change in ammonia concentration after ingestion of a test meal under 2 conditions (enriched fructose diet vs poor fructose diet) according to a crossover design
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Time Frame: -30 min before ingestion of a test meal to 120 min after ingestion of a test meal
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Plasma amino acid concentration
Time Frame: Time Frame: -30 min before ingestion of a test meal to 120 min after ingestion of a test meal
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Change in amino acid concentration after ingestion of a test meal under 2 conditions (enriched fructose diet vs poor fructose diet) according to a crossover design
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Time Frame: -30 min before ingestion of a test meal to 120 min after ingestion of a test meal
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Plasma alanine transaminase (ALAT) concentration
Time Frame: Time Frame: -30 min before ingestion of a test meal to 120 min after ingestion of a test meal
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Change in alanine transminase (ALAT) concentration after ingestion of a test meal under 2 conditions (enriched fructose diet vs poor fructose diet) according to a crossover design
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Time Frame: -30 min before ingestion of a test meal to 120 min after ingestion of a test meal
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Plasma aspartate transaminase (ASAT) concentration
Time Frame: Time Frame: -30 min before ingestion of a test meal to 120 min after ingestion of a test meal
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Change in aspartate transaminase (ASAT) concentration after ingestion of a test meal under 2 conditions (enriched fructose diet vs poor fructose diet) according to a crossover design
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Time Frame: -30 min before ingestion of a test meal to 120 min after ingestion of a test meal
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Urine metabolome concentration
Time Frame: Time Frame: 24 hour urine collection before ingestion of a test meal and after 7 days of 2 conditions (enriched fructose diet vs poor fructose diet) according to a crossover design
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Change in urine metabolome profile after low fructose diet and an enriched fructose diet according to a crossover design
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Time Frame: 24 hour urine collection before ingestion of a test meal and after 7 days of 2 conditions (enriched fructose diet vs poor fructose diet) according to a crossover design
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Urine creatinine concentration
Time Frame: Time Frame: 24 hour urine collection before ingestion of a test meal and after 7 days of 2 conditions (enriched fructose diet vs poor fructose diet) according to a crossover design
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Change in urine creatinine profile after low fructose diet and an enriched fructose diet according to a crossover design
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Time Frame: 24 hour urine collection before ingestion of a test meal and after 7 days of 2 conditions (enriched fructose diet vs poor fructose diet) according to a crossover design
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Urine urea concentration
Time Frame: Time Frame: 24 hour urine collection before ingestion of a test meal and after 7 days of 2 conditions (enriched fructose diet vs poor fructose diet) according to a crossover design
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Change in urine urea profile after low fructose diet and an enriched fructose diet according to a crossover design
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Time Frame: 24 hour urine collection before ingestion of a test meal and after 7 days of 2 conditions (enriched fructose diet vs poor fructose diet) according to a crossover design
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Urine uric acid concentration
Time Frame: Time Frame: 24 hour urine collection before ingestion of a test meal and after 7 days of 2 conditions (enriched fructose diet vs poor fructose diet) according to a crossover design
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Change in urine uric acid profile after low fructose diet and an enriched fructose diet according to a crossover design
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Time Frame: 24 hour urine collection before ingestion of a test meal and after 7 days of 2 conditions (enriched fructose diet vs poor fructose diet) according to a crossover design
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Body weight
Time Frame: Time Frame: at baseline before study intervention and at the end of each conditions (enriched fructose diet vs poor fructose diet) according to a crossover design
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Change of body weight after low fructose diet and an enriched fructose diet according to a crossover design
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Time Frame: at baseline before study intervention and at the end of each conditions (enriched fructose diet vs poor fructose diet) according to a crossover design
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Blood pressure
Time Frame: Time Frame: at baseline before study intervention and at the end of each conditions (enriched fructose diet vs poor fructose diet) according to a crossover design
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Change of systolic and diastolic pressure after low fructose diet and an enriched fructose diet according to a crossover design
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Time Frame: at baseline before study intervention and at the end of each conditions (enriched fructose diet vs poor fructose diet) according to a crossover design
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-00289
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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