ObesityFIDNLNCT01792089
Fructose-induced Intestinal de Novo Lipogenesis
An observational study of Obesity, run by University of Lausanne at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- fat+protein meal, Fat + protein + 13C fructose meal and Fat+protein+13C fructose+glucose meal
- How many people
- 24 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2013to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- age 18-50 years
- sex male or female
- less than 2 kg body weight change over the past 3 months subjects
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud
About this study
Official title: 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
- Conditions
- Obesity
- Being tested
- fat+protein meal, Fat + protein + 13C fructose meal, Fat+protein+13C fructose+glucose meal, 13C Fat + whey protein, 13C Fat + whey protein + glucose+ glucose meal
- Keywords
- de novo lipogenesis, fructose, roux-en-Y gastric bypass, post-prandial triglycerides
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fat+protein mealOther
cream+ whey protein
Fat + protein + 13C fructose mealOther
cream+ whey protein +13C fructose
Fat+protein+13C fructose+glucose mealOther
Cream + whey protein + glucose:13C fructose mixture
13C Fat + whey proteinOther
cream labelled with 13C palmitate + whey protein
13C Fat + whey protein + glucose+ glucose mealOther
cream labelled with 13C palmitate + whey protein + glucose:fructose mixture
| Study group | Role | What they receive |
|---|---|---|
| non-obese healthy subjects | subjects with BMI<25 and no known disease Receives: 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 | |
| post-gastric bypass | post-obese subjects 12-48 months after Roux-en-Y gastric bypass Receives: Other: fat+protein meal; Other: Fat + protein + 13C fructose meal; Other: 13C Fat + whey protein + glucose+ glucose meal | |
| matched control subjects | Nonobese, healthy subjects of similar age, weight, and gender ratio, than post-bypass subjects Receives: Other: fat+protein meal; Other: Fat + protein + 13C fructose meal; Other: 13C Fat + whey protein + glucose+ glucose meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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,
Measured: 0-8-hour post-prandial
Secondary outcomes (1)
post-prandial triglyceride profile (sub-studies 1 and 2
Triglyceride will be measured in the chylomicron, VLDL, LDL and HDL fractions of post-prandial blood samples
Measured: 0-8 hour post-prandial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luc Tappy, MD, University of Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01792089
- Sponsor's protocol ID
- 193/11
- Acronym
- FIDNL
- Status last verified
- Mar 2019
- First submitted
- 12 Feb 2013
- Last updated
- 25 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25029210
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measure of Intestinal Lipogenesis in Healthy Volunteers and Obese Subjects Before and After Gastroplasty: Modulation by Glucose and Fructose
- ClinicalTrials.gov ID
- NCT01792089
- Acronym / sponsor ID
- FIDNL / 193/11
- Conditions
- Obesity
- Keywords
- de novo lipogenesis, fructose, roux-en-Y gastric bypass, post-prandial triglycerides
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of LausanneUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 15 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| non-obese healthy subjects | – | 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 mealsubjects with BMI<25 and no known disease |
| post-gastric bypass | – | Other: fat+protein meal, Other: Fat + protein + 13C fructose meal, Other: 13C Fat + whey protein + glucose+ glucose mealpost-obese subjects 12-48 months after Roux-en-Y gastric bypass |
| matched control subjects | – | Other: fat+protein meal, Other: Fat + protein + 13C fructose meal, Other: 13C Fat + whey protein + glucose+ glucose mealNonobese, healthy subjects of similar age, weight, and gender ratio, than post-bypass subjects |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (3 listed)
- age 18-50 years
- sex male or female
- less than 2 kg body weight change over the past 3 months subjects
Key exclusion criteria (8 listed)
- antidiabetic and hypolipemic drugs
- alcohol consumption >20g/day
- severe eating disorders
- severe psychological problems
- vegetarian diet or other specific diet
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fat+protein mealcream+ whey protein | Other | matched control subjects, non-obese healthy subjects, post-gastric bypass |
| Fat + protein + 13C fructose mealcream+ whey protein +13C fructose | Other | matched control subjects, non-obese healthy subjects, post-gastric bypass |
| Fat+protein+13C fructose+glucose mealCream + whey protein + glucose:13C fructose mixture | Other | non-obese healthy subjects |
| 13C Fat + whey proteincream labelled with 13C palmitate + whey protein | Other | non-obese healthy subjects |
| 13C Fat + whey protein + glucose+ glucose mealcream labelled with 13C palmitate + whey protein + glucose:fructose mixture | Other | matched control subjects, non-obese healthy subjects, post-gastric bypass |
Primary outcome
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
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,
1 secondary outcome
post-prandial triglyceride profile (sub-studies 1 and 2
Time frame: 0-8 hour post-prandial
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2019.
- Derived from this study: PubMed 25029210Theytaz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by University of Lausanne at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intestinal de novo lipogenesis (sub-study 1) (time frame: 0-8-hour post-prandial). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01792089, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2019.