- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01792089
Fructose-induced Intestinal de Novo Lipogenesis (FIDNL)
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
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
VD
-
Lausanne, VD, Switzerland
- Centre Hospitalier Universitaire Vaudois
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 193/11
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
-
Dr. Christopher McGowanRecruitingObesity Prevention | Obesity Recidivism | Obesity and Overweight | Obesity and Obesity-related Medical ConditionsUnited States
-
Central Hospital, Nancy, FranceNot yet recruiting
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsCompletedOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
Dr. Christopher McGowanRecruitingObesity Prevention | Obesity Recidivism | Obesity and Overweight | GLP-1 | Obesity and Obesity-related Medical Conditions | Ablation TechniquesUnited States
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
Clinical Trials on fat+protein meal
-
The Affiliated Nanjing Drum Tower Hospital of Nanjing...RecruitingObesity | Feeding Behavior | Metabolomics | Brain Function | MacronutrientsChina
-
USDA, Western Human Nutrition Research CenterTerminatedObesity | Overweight | Body WeightUnited States
-
Cumhuriyet UniversityHacettepe University Scientific Research Projects Coordination UnitCompletedAdolescent | Type 1 Diabetes MellitusTurkey (Türkiye)
-
Medical University of BialystokMinistry of Science and Higher Education, PolandCompletedDiabetes Mellitus, Type 2 | Metabolic Syndrome | Diet Modification | Overweight and Obesity | Genetic PredispositionPoland
-
McMaster UniversityCompletedGlucose Tolerance ImpairedCanada
-
Pennington Biomedical Research CenterCompletedDiabetes Mellitus, Type 2United States
-
Hospital Universitari Vall d'Hebron Research InstituteCompleted
-
Iowa State UniversityCompleted
-
Khyber Medical University PeshawarCompletedObesity, OverweightPakistan
-
Paul PoirierCompletedType 2 Diabetes | Glycemic ResponseCanada