Fructose Extra-splanchnic Metabolism and Its Effects on S... | NCT03195062

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

NCT03195062

Sponsor

University of Lausanne

Status

Completed

Last Update Posted

Oct 18, 2018Actual

Enrollment

9Actual

Phase

Not Applicable

Conditions

Test Meal

Interventions

Test meal

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 23, 2017Actual

Primary Completion Date

Jun 30, 2018Actual

Completion Date

Aug 31, 2018Actual

First Submitted Date

Mar 23, 2017

First Submission Date that Met QC Criteria

Jun 19, 2017

First Posted Date

Jun 22, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 17, 2018

Last Update Posted Date

Oct 18, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Test meal	Experimental	The subjects will receive a liquid test meal containing glucose and fructose with 13C fructose.	Other: Test meal

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Test meal	Other	Liquid test meal (fructose+glucose)	Test meal

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Lausanne		Lausanne		1005	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided