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Fructose-induced Intestinal de Novo Lipogenesis (FIDNL)

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ClinicalTrials.gov Identifier: NCT01792089
Recruitment Status : Completed
First Posted : February 15, 2013
Last Update Posted : March 25, 2019
Sponsor:
Information provided by (Responsible Party):
Luc Tappy, MD, University of Lausanne

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
Obesity 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

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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 : February 2013
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Fructose

Group/Cohort 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




Primary Outcome Measures :
  1. 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

  2. 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,


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01792089


Locations
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Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, VD, Switzerland
Sponsors and Collaborators
University of Lausanne

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Luc Tappy, MD, Professor, University of Lausanne
ClinicalTrials.gov Identifier: NCT01792089     History of Changes
Other Study ID Numbers: 193/11
First Posted: February 15, 2013    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019
Keywords provided by Luc Tappy, MD, University of Lausanne:
de novo lipogenesis
fructose
roux-en-Y gastric bypass
post-prandial triglycerides