NCT01792089

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

February 12, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 15, 2013

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 25, 2019

Status Verified

March 1, 2019

Enrollment Period

3.8 years

First QC Date

February 12, 2013

Last Update Submit

March 22, 2019

Conditions

Keywords

de novo lipogenesisfructoseroux-en-Y gastric bypasspost-prandial triglycerides

Outcome Measures

Primary Outcomes (2)

  • Intestinal de novo lipogenesis (sub-study 1)

    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)

    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 Outcomes (1)

  • post-prandial triglyceride profile (sub-studies 1 and 2

    0-8 hour post-prandial

Study Arms (3)

non-obese healthy subjects

subjects with BMI\<25 and no known disease

Other: fat+protein mealOther: Fat + protein + 13C fructose mealOther: Fat+protein+13C fructose+glucose mealOther: 13C Fat + whey proteinOther: 13C Fat + whey protein + glucose+ glucose meal

post-gastric bypass

post-obese subjects 12-48 months after Roux-en-Y gastric bypass

Other: fat+protein mealOther: Fat + protein + 13C fructose mealOther: 13C Fat + whey protein + glucose+ glucose meal

matched control subjects

Nonobese, healthy subjects of similar age, weight, and gender ratio, than post-bypass subjects

Other: fat+protein mealOther: Fat + protein + 13C fructose mealOther: 13C Fat + whey protein + glucose+ glucose meal

Interventions

cream+ whey protein

matched control subjectsnon-obese healthy subjectspost-gastric bypass

cream+ whey protein +13C fructose

matched control subjectsnon-obese healthy subjectspost-gastric bypass

Cream + whey protein + glucose:13C fructose mixture

non-obese healthy subjects

cream labelled with 13C palmitate + whey protein

non-obese healthy subjects

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

matched control subjectsnon-obese healthy subjectspost-gastric bypass

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, Switzerland

Location

Related Publications (1)

  • Theytaz F, de Giorgi S, Hodson L, Stefanoni N, Rey V, Schneiter P, Giusti V, Tappy L. Metabolic fate of fructose ingested with and without glucose in a mixed meal. Nutrients. 2014 Jul 15;6(7):2632-49. doi: 10.3390/nu6072632.

MeSH Terms

Conditions

Obesity

Interventions

CD36 AntigensProteinsWhey Proteins

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Platelet Membrane GlycoproteinsMembrane GlycoproteinsGlycoproteinsGlycoconjugatesCarbohydratesFatty Acid Transport ProteinsMembrane Transport ProteinsCarrier ProteinsAmino Acids, Peptides, and ProteinsMembrane ProteinsReceptors, Cell SurfaceReceptors, ImmunologicScavenger Receptors, Class BReceptors, ScavengerReceptors, LDLReceptors, LipoproteinMilk ProteinsAnimal Proteins, DietaryDietary ProteinsWheyMilkDairy ProductsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 12, 2013

First Posted

February 15, 2013

Study Start

February 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

March 25, 2019

Record last verified: 2019-03

Locations