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FIDNL: Fructose-induced Intestinal de Novo Lipogenesis

Sponsor
University of Lausanne (Other)
Overall Status
Completed
CT.gov ID
NCT01792089
Collaborator
(none)
24
Enrollment
1
Location
46
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: fat+protein meal
  • Other: Fat + protein + 13C fructose meal
  • Other: Fat+protein+13C fructose+glucose meal
  • Other: 13C Fat + whey protein
  • Other: 13C Fat + whey protein + glucose+ glucose meal

Study Design

Study Type:
Observational
Actual Enrollment :
24 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Measure of Intestinal Lipogenesis in Healthy Volunteers and Obese Subjects Before and After Gastroplasty: Modulation by Glucose and Fructose
Study Start Date :
Feb 1, 2013
Actual Primary Completion Date :
Dec 1, 2016
Actual Study Completion Date :
Dec 1, 2016

Arms and Interventions

Arm Intervention/Treatment
non-obese healthy subjects

subjects with BMI<25 and no known disease

Other: fat+protein meal
cream+ whey protein

Other: Fat + protein + 13C fructose meal
cream+ whey protein +13C fructose

Other: Fat+protein+13C fructose+glucose meal
Cream + whey protein + glucose:13C fructose mixture

Other: 13C Fat + whey protein
cream labelled with 13C palmitate + whey protein

Other: 13C Fat + whey protein + glucose+ glucose meal
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

Other: fat+protein meal
cream+ whey protein

Other: Fat + protein + 13C fructose meal
cream+ whey protein +13C fructose

Other: 13C Fat + whey protein + glucose+ glucose meal
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

Other: fat+protein meal
cream+ whey protein

Other: Fat + protein + 13C fructose meal
cream+ whey protein +13C fructose

Other: 13C Fat + whey protein + glucose+ glucose meal
cream labelled with 13C palmitate + whey protein + glucose:fructose mixture

Outcome Measures

Primary Outcome Measures

  1. Intestinal de novo lipogenesis (sub-study 1) [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

  2. Postprandial exogenous, labelled palmitate concentration (sub-study 2) [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,

Secondary Outcome Measures

  1. post-prandial triglyceride profile (sub-studies 1 and 2 [0-8 hour post-prandial]

    Triglyceride will be measured in the chylomicron, VLDL, LDL and HDL fractions of post-prandial blood samples

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre Hospitalier Universitaire Vaudois Lausanne VD Switzerland

Sponsors and Collaborators

  • University of Lausanne

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Luc Tappy, MD, Professor, University of Lausanne
ClinicalTrials.gov Identifier:
NCT01792089
Other Study ID Numbers:
  • 193/11
First Posted:
Feb 15, 2013
Last Update Posted:
Mar 25, 2019
Last Verified:
Mar 1, 2019
Keywords provided by Luc Tappy, MD, Professor, University of Lausanne
de novo lipogenesis
fructose
roux-en-Y gastric bypass
post-prandial triglycerides

Study Results

No Results Posted as of Mar 25, 2019