Skip to main content
OpenTrials
Completed

NCT Number: NCT03545581

Fructose Supplementation in Carriers for Hereditary Fructose Intolerance

This study aimed to examine metabolic response to a short-term fructose enriched diet in carriers for hereditary fructose intolerance compared to controls. Effects of fructose coffees will be assessed in 7 healthy volunteers and 7 subjects with heterozygous mutation for ALDOB gene in a randomized, controlled, crossover trial.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hereditary Fructose Intolerance Carbohydrate Metabolism, Inborn Errors Congenital, Hereditary, and Neonatal Diseases and Abnormalities Fructose Intolerance Fructose Metabolism, Inborn Errors Genetic Diseases, Inborn Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guillaume Debray

Liège, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Experimental diet Fru rich diet

Other

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)

Experimental low Fru diet

Other

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)

Primary outcomes

  1. Metabolite concentration

    Time frame: Time Frame: -30 min before ingestion of a test meal to 120 min after ingestion of a test meal

    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

Secondary outcomes

  1. Plasma glucose concentration

    Time frame: Time Frame: -30 min before ingestion of a test meal to 120 min after ingestion of a test meal

    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

  2. Plasma insulin concentration

    Time frame: Time Frame: -30 min before ingestion of a test meal to 120 min after ingestion of a test meal

    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

  3. Plasma fructose concentration

    Time frame: Time Frame: -30 min before ingestion of a test meal to 120 min after ingestion of a test meal

    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

  4. 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

    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

  5. Plasma lactate concentration

    Time frame: Time Frame: -30 min before ingestion of a test meal to 120 min after ingestion of a test meal

    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

  6. Plasma urea concentration

    Time frame: Time Frame: -30 min before ingestion of a test meal to 120 min after ingestion of a test meal

    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

  7. Plasma creatinine concentration

    Time frame: Time Frame: -30 min before ingestion of a test meal to 120 min after ingestion of a test meal

    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

  8. Plasma phosphate concentration

    Time frame: Time Frame: -30 min before ingestion of a test meal to 120 min after ingestion of a test meal

    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

  9. Plasma triglycerides concentration

    Time frame: Time Frame: -30 min before ingestion of a test meal to 120 min after ingestion of a test meal

    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

  10. Plasma metabolome concentration

    Time frame: Time Frame: -30 min before ingestion of a test meal to 120 min after ingestion of a test meal

    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

  11. Plasma ammonia concentration

    Time frame: Time Frame: -30 min before ingestion of a test meal to 120 min after ingestion of a test meal

    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

  12. 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

    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

  13. 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

    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

  14. 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

    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

  15. 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

    Change in urine metabolome profile after low fructose diet and an enriched fructose diet according to a crossover design

  16. 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

    Change in urine creatinine profile after low fructose diet and an enriched fructose diet according to a crossover design

  17. 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

    Change in urine urea profile after low fructose diet and an enriched fructose diet according to a crossover design

  18. 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

    Change in urine uric acid profile after low fructose diet and an enriched fructose diet according to a crossover design

  19. 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

    Change of body weight after low fructose diet and an enriched fructose diet according to a crossover design

  20. 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

    Change of systolic and diastolic pressure after low fructose diet and an enriched fructose diet according to a crossover design

Sponsors and collaborators

Lead sponsor

University of Lausanne

Other

Collaborators

  • University of Liege

Registry information

Official study title

Metabolic Effects of Short-term Dietary Supplementation With Fructose in Carriers for Hereditary Fructose Intolerance

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Jun 4, 2018
Registry last updated
Apr 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.