Fructose-induced Intestinal de Novo Lipogenesis (FIDNL)

March 22, 2019 updated by: Luc Tappy, MD, University of Lausanne

Measure of Intestinal Lipogenesis in Healthy Volunteers and Obese Subjects Before and After Gastroplasty: Modulation by Glucose and Fructose

8 healthy volunteers, 8 pre-bypass obese subjects, 8 subjects between 12-18 months post-bypass, and 8 subjects matched to the post-bypass patients will be studied in two sub-studies Sub-study 1) after ingestion of two or three different of the following test-meals: A)cream and whey protein B)cream, whey protein and fructose + 13C6 fructose C)test meal with cream, whey protein, fructose and glucose + 13C6 fructose Their intestinal de novo lipogenesis will be estimated by measuring 13C-palmitate on triglyceride-rich lipoprotein particles associated with apoB48 in blood Sub-study 2) after ingestion of two or three different of the following test-meals: A)cream labelled with 13C6 palmitic acid and whey protein B))cream labelled with 13C6 palmitic acid, whey protein, fructose and glucose

Their intestinal de novo lipogenesis will be estimated by measuring 13C-palmitate on triglyceride-rich lipoprotein particles associated with apoB48 in blood in sub-study 1

Their exogenous lipid absorption kinetics will be assessed by measuring 13C palmitate on triglyceride-rich lipoprotein particles associated with apoB48 in sub-study 2

Study Overview

Study Type

Observational

Enrollment (Actual)

24

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

    • VD
      • Lausanne, VD, Switzerland
        • Centre Hospitalier Universitaire Vaudois

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

25 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

8 non-obese healthy male and female subjects with BMI <25 8 obese male and female subjects with BMI> 35 8 post-gastric bypass male and female subjects 8 healthy subjects matched to post-gastric bypass subjects for age, gender and weight

Description

Inclusion Criteria:

  • age 18-50 years
  • sex male or female
  • less than 2 kg body weight change over the past 3 months subjects

Exclusion Criteria:

  • antidiabetic and hypolipemic drugs
  • alcohol consumption >20g/day
  • severe eating disorders
  • severe psychological problems
  • vegetarian diet or other specific diet
  • consumption of illicit substances
  • pregnancy
  • weight gain or weight loss > 1 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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
non-obese healthy subjects
subjects with BMI<25 and no known disease
cream+ whey protein
cream+ whey protein +13C fructose
Cream + whey protein + glucose:13C fructose mixture
cream labelled with 13C palmitate + whey protein
cream labelled with 13C palmitate + whey protein + glucose:fructose mixture
post-gastric bypass
post-obese subjects 12-48 months after Roux-en-Y gastric bypass
cream+ whey protein
cream+ whey protein +13C fructose
cream labelled with 13C palmitate + whey protein + glucose:fructose mixture
matched control subjects
Nonobese, healthy subjects of similar age, weight, and gender ratio, than post-bypass subjects
cream+ whey protein
cream+ whey protein +13C fructose
cream labelled with 13C palmitate + whey protein + glucose:fructose mixture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intestinal de novo lipogenesis (sub-study 1)
Time Frame: 0-8-hour post-prandial
Measurement of total TG and 13C palmitate in chylomicrons: The sf >20 fraction of post-prandial blood samples will be prepared, and non-chylomicrons, apoB100-containing lipoprotein will be removes by immuno-affinity chromatography using a specific anti-apoB100 antibody
0-8-hour post-prandial
Postprandial exogenous, labelled palmitate concentration (sub-study 2)
Time Frame: 0-8-hour post-prandial
Measurement of total TG and 13C palmitate in chylomicrons of sf >20 fraction of post-prandial blood samples will be prepared,
0-8-hour post-prandial

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
post-prandial triglyceride profile (sub-studies 1 and 2
Time Frame: 0-8 hour post-prandial
Triglyceride will be measured in the chylomicron, VLDL, LDL and HDL fractions of post-prandial blood samples
0-8 hour post-prandial

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the 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

February 1, 2013

Primary Completion (ACTUAL)

December 1, 2016

Study Completion (ACTUAL)

December 1, 2016

Study Registration Dates

First Submitted

February 12, 2013

First Submitted That Met QC Criteria

February 13, 2013

First Posted (ESTIMATE)

February 15, 2013

Study Record Updates

Last Update Posted (ACTUAL)

March 25, 2019

Last Update Submitted That Met QC Criteria

March 22, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

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.

Clinical Trials on Obesity

Clinical Trials on fat+protein meal

Subscribe