NCT03545581

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2018

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 7, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 4, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

April 22, 2019

Status Verified

April 1, 2019

Enrollment Period

7 months

First QC Date

May 7, 2018

Last Update Submit

April 19, 2019

Conditions

Hereditary Fructose Intolerance

Keywords

FructoseUric acidGlucose homeostasis

Outcome Measures

Primary Outcomes (1)

  • Metabolite concentration

    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

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

Secondary Outcomes (20)

  • Plasma glucose concentration

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

  • Plasma insulin concentration

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

  • Plasma fructose concentration

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

  • Plasma uric acid concentration

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

  • Plasma lactate concentration

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

  • +15 more secondary outcomes

Study Arms (2)

Experimental diet Fru rich diet

OTHER

Enriched fructose diet from day 1 to day 7.

Other: Experimental diet Fru rich diet

Experimental low Fru diet

OTHER

Low fructose diet from day 1 to day 7.

Other: Experimental low Fru diet

Interventions

Experimental diet Fru rich dietOTHER

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 diet Fru rich diet
Experimental low Fru dietOTHER

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)

Experimental low Fru diet

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Case subjects: Heterozygous carriers for ALDOB mutation confirmed by molecular analysis
  • Control subjects: healthy individuals matched for weight and age to subjects

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guillaume Debray

Liège, Belgium

Location

Related Publications (1)

  • Debray FG, Seyssel K, Fadeur M, Tappy L, Paquot N, Tran C. Effect of a high fructose diet on metabolic parameters in carriers for hereditary fructose intolerance. Clin Nutr. 2021 Jun;40(6):4246-4254. doi: 10.1016/j.clnu.2021.01.026. Epub 2021 Jan 27.

    PMID: 33551217DERIVED

MeSH Terms

Conditions

Fructose Intolerance

Condition Hierarchy (Ancestors)

Fructose Metabolism, Inborn ErrorsCarbohydrate Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 7, 2018

First Posted

June 4, 2018

Study Start

May 1, 2018

Primary Completion

December 1, 2018

Study Completion

April 1, 2019

Last Updated

April 22, 2019

Record last verified: 2019-04

Locations

BE(1)