NCT03195062

Brief Summary

In parallel to the dramatic rise in metabolic diseases and diabetes observed over the past fifty years, the generalization of added sugar in processed food led to a marked increase in fructose consumption in almost all countries, and epidemiological studies demonstrated that the consumption of sugar-sweetened beverage (containing at least 50% of fructose) is associated with the development of diabetes, hepatic steatosis, dyslipidemia and obesity. The objective of the study is to measure the amount of fructose that escape first-pass hepatic extraction after oral ingestion (fructose+glucose), and gain insights into its metabolic fates with the use of tracers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2017

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

March 23, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 22, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
Last Updated

October 18, 2018

Status Verified

October 1, 2018

Enrollment Period

1.3 years

First QC Date

March 23, 2017

Last Update Submit

October 17, 2018

Conditions

Test Meal

Keywords

FructoseObesityMetabolismPost-prandial kinetics

Outcome Measures

Primary Outcomes (1)

  • Measurement of the amount of fructose that escape first-pass hepatic extraction after oral ingestion.

    Calculation with 13C fructose enrichment in blood samples at T0; 30; 60; 90; 120; 150; 180; 210 and 240 min.

    The quantity of 13C fructose will be calculated, during the post prandial period, until 240 min.

Study Arms (1)

Test meal

EXPERIMENTAL

The subjects will receive a liquid test meal containing glucose and fructose with 13C fructose.

Other: Test meal

Interventions

Test mealOTHER

Liquid test meal (fructose+glucose)

Test meal

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged from 18 to 40 years
  • Body Mass Index of 18.5 to 25 kg/m²
  • Sex male of female

You may not qualify if:

  • Fructose intolerance
  • Antidiabetic and hypolipemic drugs
  • Alcohol consumption \>10g/day
  • Severe eating disorders
  • Severe psychological problems
  • Vegetarian diet or other specific diet
  • Consumption of illicit substances
  • Pregnancy
  • Weight gain or weight loss \> 3 kg in the last 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Lausanne

Lausanne, 1005, Switzerland

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Professor

Study Record Dates

First Submitted

March 23, 2017

First Posted

June 22, 2017

Study Start

March 23, 2017

Primary Completion

June 30, 2018

Study Completion

August 31, 2018

Last Updated

October 18, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)