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
1 other identifier
observational
24
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2013
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 12, 2013
CompletedFirst Posted
Study publicly available on registry
February 15, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedMarch 25, 2019
March 1, 2019
3.8 years
February 12, 2013
March 22, 2019
Conditions
Keywords
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
post-gastric bypass
post-obese subjects 12-48 months after Roux-en-Y gastric bypass
matched control subjects
Nonobese, healthy subjects of similar age, weight, and gender ratio, than post-bypass subjects
Interventions
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
Eligibility Criteria
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
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.
PMID: 25029210DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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