Fructose Extra-splanchnic Metabolism and Its Effects on Systemic Flux of Substrates (FruPP) (FruPP)

October 17, 2018 updated by: Luc Tappy, MD, University of Lausanne

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Lausanne, Switzerland, 1005
        • University of Lausanne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test meal
The subjects will receive a liquid test meal containing glucose and fructose with 13C fructose.
Liquid test meal (fructose+glucose)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of the amount of fructose that escape first-pass hepatic extraction after oral ingestion.
Time Frame: The quantity of 13C fructose will be calculated, during the post prandial period, until 240 min.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2017

Primary Completion (Actual)

June 30, 2018

Study Completion (Actual)

August 31, 2018

Study Registration Dates

First Submitted

March 23, 2017

First Submitted That Met QC Criteria

June 19, 2017

First Posted (Actual)

June 22, 2017

Study Record Updates

Last Update Posted (Actual)

October 18, 2018

Last Update Submitted That Met QC Criteria

October 17, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 2016-01828

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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