- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03195062
Fructose Extra-splanchnic Metabolism and Its Effects on Systemic Flux of Substrates (FruPP) (FruPP)
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Lausanne, Switzerland, 1005
- University of Lausanne
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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Liquid test meal (fructose+glucose)
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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.
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Calculation with 13C fructose enrichment in blood samples at T0; 30; 60; 90; 120; 150; 180; 210 and 240 min.
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The quantity of 13C fructose will be calculated, during the post prandial period, until 240 min.
|
Collaborators and Investigators
Sponsor
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
Other Study ID Numbers
- 2016-01828
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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