Cardiometabolic RiskVALOBAB-DNCT02146339
Impact of Milk Polar Lipids on Lipids Digestion, Absorption and Metabolism
A study testing Cheese n°1- cheese n°2 - cheese n°3, Cheese n°1- cheese n°3 - cheese n°2 and cheese n°2 - cheese n°1- cheese n°3 in people with Cardiometabolic Risk, run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
Polar lipids have a specific chemical structure: they are an essential component of human cell membranes, play a major role in the nervous system and also influence the metabolic pathways including the cholesterol metabolism. Polar lipids are used in food-processing industry for their emulsification properties. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cardiometabolic Risk
- What is being tested?
- Cheese n°1- cheese n°2 - cheese n°3, Cheese n°1- cheese n°3 - cheese n°2 and cheese n°2 - cheese n°1- cheese n°3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 2 sitesFrance
- Study dates
- Apr 2014to Nov 2015
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged between 18 and 75 years
- Having undergone a temporary or permanent ileostomy,
- Considered to have well-functioning ileostomy
- Normal (or not clinically significant) lipid parameters
Who cannot join
- Ileostomy due to an ongoing digestive cancer
- Ileostomy due to a Chrohn's disease
- Dairy products allergy or intolerance
- Medication that could interfere with lipid metabolism
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre de recherche en Nutrition Humaine-Auvergne -Unité d'Exploration Nutritionnelle
Clermont-Ferrand, 63000
Centre de Recherche en Nutrition Humaine Rhône-Alpes
Lyon
About this study
Official title: Impact of Milk Polar Lipids Content in a Test Meal on Lipid Composition of Ileostomy Fluid and Consequences on Postprandial Dietary Cholesterol and Fatty Acid Metabolism.
Polar lipids have a specific chemical structure: they are an essential component of human cell membranes, play a major role in the nervous system and also influence the metabolic pathways including the cholesterol metabolism.
Polar lipids are used in food-processing industry for their emulsification properties. The most famous emulsifier is soya lecithin but milk also naturally contains natural emulsifiers such as polar lipids. Milk polar lipids are rich in sphingomyelin and they may have beneficial effects on lipid metabolism in the context of metabolic diseases of nutritional origin.
Read more
The purpose of this research is to study the variation of sphingomyelin content at the ileum's end after the consumption of different doses of milk polar lipids, and consequences on the intestinal absorption and metabolism of fatty acids and cholesterol.
The subjects will be taking three different test meals varying by their milk polar lipids content.
It is a bi-centric study with a centre in LYON (Centre de Recherche en Nutrition Humaine Rhône-Alpes) and CLERMONT-FERRAND (Centre de Recherche en Nutrition Humaine Auvergne).
- Conditions
- Cardiometabolic Risk
- Being tested
- Cheese n°1- cheese n°2 - cheese n°3, Cheese n°1- cheese n°3 - cheese n°2, cheese n°2 - cheese n°1- cheese n°3, Cheese n°2- cheese n°3 - cheese n°1, Cheese n°3 - cheese n°1- cheese n°2
- Keywords
- nutrition, milk, polar lipids, cardiometabolic risk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cheese n°1- cheese n°2 - cheese n°3Other
Each subject will receive a single dose of cheese n°1, then cheese n°2 after a wash-out period of 4 weeks, then cheese n°3 after a wash-out period of 4 weeks.
Cheese n°1 = unfortified cheese product Cheese n°2 = 3 g milk polar lipid fortified cheese product Cheese n°3 = 5 g milk polar lipid fortified cheese product
Cheese n°1- cheese n°3 - cheese n°2Other
Each subject will receive a single dose of cheese n°1, then cheese n°3 after a wash-out period of 4 weeks, then cheese n°2 after a wash-out period of 4 weeks.
Cheese n°1 = unfortified cheese product Cheese n°2 = 3 g milk polar lipid fortified cheese product Cheese n°3 = 5 g milk polar lipid fortified cheese product
cheese n°2 - cheese n°1- cheese n°3Other
Each subject will receive a single dose of cheese n°2, then cheese n°1 after a wash-out period of 4 weeks, then cheese n°3 after a wash-out period of 4 weeks.
Cheese n°1 = unfortified cheese product Cheese n°2 = 3 g milk polar lipid fortified cheese product Cheese n°3 = 5 g milk polar lipid fortified cheese product
Cheese n°2- cheese n°3 - cheese n°1Other
Each subject will receive a single dose of cheese n°2, then cheese n°3 after a wash-out period of 4 weeks, then cheese n°1 after a wash-out period of 4 weeks.
Cheese n°1 = unfortified cheese product Cheese n°2 = 3 g milk polar lipid fortified cheese product Cheese n°3 = 5 g milk polar lipid fortified cheese product
Cheese n°3 - cheese n°1- cheese n°2Other
Each subject will receive a single dose of cheese n°3, then cheese n°1 after a wash-out period of 4 weeks, then cheese n°2 after a wash-out period of 4 weeks.
Cheese n°1 = unfortified cheese product Cheese n°2 = 3 g milk polar lipid fortified cheese product Cheese n°3 = 5 g milk polar lipid fortified cheese product
Cheese n°3- cheese n°2 - cheese n°1Other
Each subject will receive a single dose of cheese n°3, then cheese n°2 after a wash-out period of 4 weeks, then cheese n°1 after a wash-out period of 4 weeks.
Cheese n°1 = unfortified cheese product Cheese n°2 = 3 g milk polar lipid fortified cheese product Cheese n°3 = 5 g milk polar lipid fortified cheese product
| Study group | Role | What they receive |
|---|---|---|
| Unfortified-3g-5g milk polar lipid fortified cheese product | Experimental | Each subject will receive a single dose of each cheese product (100 g) containing no or 3g or 5g of milk polar lipids, 300 mg of [1,1,1]-13C-triolein and 45 mg of 2H6-cholesterol. The wash-out period is four weeks. Receives: Other: Cheese n°1- cheese n°2 - cheese n°3 |
| Unfortified-5g-3g milk polar lipid fortified cheese product | Experimental | Each subject will receive a single dose of each cheese product (100 g) containing no or 3g or 5g of milk polar lipids, 300 mg of [1,1,1]-13C-triolein and 45 mg of 2H6-cholesterol. The wash-out period is four weeks. Receives: Other: Cheese n°1- cheese n°3 - cheese n°2 |
| 3g-5g milk polar lipid fortified-unfortified cheese product | Experimental | Each subject will receive a single dose of each cheese product (100 g) containing no or 3g or 5g of milk polar lipids, 300 mg of [1,1,1]-13C-triolein and 45 mg of 2H6-cholesterol. The wash-out period is four weeks. Receives: Other: Cheese n°2- cheese n°3 - cheese n°1 |
| 3g-Unfortified-5g milk polar lipid fortified cheese product | Other | Each subject will receive a single dose of cheese n°1, then cheese n°2 after a wash-out period of 4 weeks, then cheese n°3 after a wash-out period of 4 weeks.
Cheese n°1 = unfortified cheese product Cheese n°2 = 3 g milk polar lipid fortified cheese product Cheese n°3 = 5 g milk polar lipid fortified cheese product Receives: Other: cheese n°2 - cheese n°1- cheese n°3 |
| 5g-unfortified-3g milk polar lipid fortified cheese product | Experimental | Each subject will receive a single dose of each cheese product (100 g) containing no or 3g or 5g of milk polar lipids, 300 mg of [1,1,1]-13C-triolein and 45 mg of 2H6-cholesterol. The wash-out period is four weeks. Receives: Other: Cheese n°3 - cheese n°1- cheese n°2 |
| 5g-3g milk polar lipid fortified-unfortified cheese product | Other | Each subject will receive a single dose of each cheese product (100 g) containing no or 3g or 5g of milk polar lipids, 300 mg of [1,1,1]-13C-triolein and 45 mg of 2H6-cholesterol. The wash-out period is four weeks. Receives: Other: Cheese n°3- cheese n°2 - cheese n°1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ileal sphingomyelin output
The total sphingomyelin output will be measured in the ileostomy fluids over 8 hours after the consumption of the 3 different test meals.
Measured: up to Day 63
Secondary outcomes (3)
Plasma lipids and isotopic tracers
Plasma lipids and isotopic tracers will be measured after the consumption of the 3 different test meals. Fasting and postprandial measurements over 8 hours depending on parameters.
Measured: A least Day 7, Day 35 and Day 63
Plasma glucose and insulin
Plasma glucose and insulin will be measured after the consumption of the 3 different test meals. Fasting and postprandial measurements over 8 hours.
Measured: At least Day 7, Day 35 and Day 63
Energy expenditure and substrate oxidation with indirect calorimetry
Energy metabolism and 13CO2 will be measured after the consumption of the 3 different test meals. Fasting and during all the postprandial period (8 h).
Measured: At least Day7, Day 35 and Day 63
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2014 (estimated)
- Study startApr 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiometabolic RiskStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02146339
- Sponsor's protocol ID
- 2013.828
- Acronym
- VALOBAB-D
- Status last verified
- Jan 2016
- First submitted
- 21 May 2014
- Last updated
- 27 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Le Barz M, Vors C, Combe E, Joumard-Cubizolles L, Lecomte M, Joffre F, Trauchessec M, Pesenti S, Loizon E, Breyton AE, Meugnier E, Bertrand K, Drai J, Robert C, Durand A, Cuerq C, Gaborit P, Leconte N, Bernalier-Donadille A, Cotte E, Laville M, Lambert-Porcheron S, Ouchchane L, Vidal H, Malpuech-Brugere C, Cheillan D, Michalski MC. Milk polar lipids favorably alter circulating and intestinal ceramide and sphingomyelin species in postmenopausal women. JCI Insight. 2021 May 24;6(10):e146161. doi: 10.1172/jci.insight.146161.
PubMed 33857018Vors C, Joumard-Cubizolles L, Lecomte M, Combe E, Ouchchane L, Drai J, Raynal K, Joffre F, Meiller L, Le Barz M, Gaborit P, Caille A, Sothier M, Domingues-Faria C, Blot A, Wauquier A, Blond E, Sauvinet V, Gesan-Guiziou G, Bodin JP, Moulin P, Cheillan D, Vidal H, Morio B, Cotte E, Morel-Laporte F, Laville M, Bernalier-Donadille A, Lambert-Porcheron S, Malpuech-Brugere C, Michalski MC. Milk polar lipids reduce lipid cardiovascular risk factors in overweight postmenopausal women: towards a gut sphingomyelin-cholesterol interplay. Gut. 2020 Mar;69(3):487-501. doi: 10.1136/gutjnl-2018-318155. Epub 2019 Jun 12.
PubMed 31189655
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Milk Polar Lipids Content in a Test Meal on Lipid Composition of Ileostomy Fluid and Consequences on Postprandial Dietary Cholesterol and Fatty Acid Metabolism.
- ClinicalTrials.gov ID
- NCT02146339
- Acronym / sponsor ID
- VALOBAB-D / 2013.828
- Conditions
- Cardiometabolic Risk
- Keywords
- nutrition, milk, polar lipids, cardiometabolic risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 23 May 2014 (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.
Polar lipids have a specific chemical structure: they are an essential component of human cell membranes, play a major role in the nervous system and also influence the metabolic pathways including the cholesterol metabolism.
Polar lipids are used in food-processing industry for their emulsification properties. The most famous emulsifier is soya lecithin but milk also naturally contains natural emulsifiers such as polar lipids. Milk polar lipids are rich in sphingomyelin and they may have beneficial effects on lipid metabolism in the context of metabolic diseases of nutritional origin.
The purpose of this research is to study the variation of sphingomyelin content at the ileum's end after the consumption of different doses of milk polar lipids, and consequences on the intestinal absorption and metabolism of fatty acids and cholesterol.
The subjects will be taking three different test meals varying by their milk polar lipids content.
It is a bi-centric study with a centre in LYON (Centre de Recherche en Nutrition Humaine Rhône-Alpes) and CLERMONT-FERRAND (Centre de Recherche en Nutrition Humaine Auvergne).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Unfortified-3g-5g milk polar lipid fortified cheese product | Experimental | Other: Cheese n°1- cheese n°2 - cheese n°3Each subject will receive a single dose of each cheese product (100 g) containing no or 3g or 5g of milk polar lipids, 300 mg of [1,1,1]-13C-triolein and 45 mg of 2H6-cholesterol. The wash-out period is four weeks. |
| Unfortified-5g-3g milk polar lipid fortified cheese product | Experimental | Other: Cheese n°1- cheese n°3 - cheese n°2Each subject will receive a single dose of each cheese product (100 g) containing no or 3g or 5g of milk polar lipids, 300 mg of [1,1,1]-13C-triolein and 45 mg of 2H6-cholesterol. The wash-out period is four weeks. |
| 3g-5g milk polar lipid fortified-unfortified cheese product | Experimental | Other: Cheese n°2- cheese n°3 - cheese n°1Each subject will receive a single dose of each cheese product (100 g) containing no or 3g or 5g of milk polar lipids, 300 mg of [1,1,1]-13C-triolein and 45 mg of 2H6-cholesterol. The wash-out period is four weeks. |
| 3g-Unfortified-5g milk polar lipid fortified cheese product | Other | Other: cheese n°2 - cheese n°1- cheese n°3Each subject will receive a single dose of cheese n°1, then cheese n°2 after a wash-out period of 4 weeks, then cheese n°3 after a wash-out period of 4 weeks. Cheese n°1 = unfortified cheese product Cheese n°2 = 3 g milk polar lipid fortified cheese product Cheese n°3 = 5 g milk polar lipid fortified cheese product |
| 5g-unfortified-3g milk polar lipid fortified cheese product | Experimental | Other: Cheese n°3 - cheese n°1- cheese n°2Each subject will receive a single dose of each cheese product (100 g) containing no or 3g or 5g of milk polar lipids, 300 mg of [1,1,1]-13C-triolein and 45 mg of 2H6-cholesterol. The wash-out period is four weeks. |
| 5g-3g milk polar lipid fortified-unfortified cheese product | Other | Other: Cheese n°3- cheese n°2 - cheese n°1Each subject will receive a single dose of each cheese product (100 g) containing no or 3g or 5g of milk polar lipids, 300 mg of [1,1,1]-13C-triolein and 45 mg of 2H6-cholesterol. The wash-out period is four weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women aged between 18 and 75 years
- Having undergone a temporary or permanent ileostomy,
- Considered to have well-functioning ileostomy
- Normal (or not clinically significant) lipid parameters
Key exclusion criteria (4 listed)
- Ileostomy due to an ongoing digestive cancer
- Ileostomy due to a Chrohn's disease
- Dairy products allergy or intolerance
- Medication that could interfere with lipid metabolism
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 |
|---|---|---|
| Cheese n°1- cheese n°2 - cheese n°3Each subject will receive a single dose of cheese n°1, then cheese n°2 after a wash-out period of 4 weeks, then cheese n°3 after a wash-out period of 4 weeks. Cheese n°1 = unfortified cheese product Cheese n°2 = 3 g milk polar lipid fortified cheese product Cheese n°3 = 5 g milk polar lipid fortified cheese product | Other | Unfortified-3g-5g milk polar lipid fortified cheese product |
| Cheese n°1- cheese n°3 - cheese n°2Each subject will receive a single dose of cheese n°1, then cheese n°3 after a wash-out period of 4 weeks, then cheese n°2 after a wash-out period of 4 weeks. Cheese n°1 = unfortified cheese product Cheese n°2 = 3 g milk polar lipid fortified cheese product Cheese n°3 = 5 g milk polar lipid fortified cheese product | Other | Unfortified-5g-3g milk polar lipid fortified cheese product |
| cheese n°2 - cheese n°1- cheese n°3Each subject will receive a single dose of cheese n°2, then cheese n°1 after a wash-out period of 4 weeks, then cheese n°3 after a wash-out period of 4 weeks. Cheese n°1 = unfortified cheese product Cheese n°2 = 3 g milk polar lipid fortified cheese product Cheese n°3 = 5 g milk polar lipid fortified cheese product | Other | 3g-Unfortified-5g milk polar lipid fortified cheese product |
| Cheese n°2- cheese n°3 - cheese n°1Each subject will receive a single dose of cheese n°2, then cheese n°3 after a wash-out period of 4 weeks, then cheese n°1 after a wash-out period of 4 weeks. Cheese n°1 = unfortified cheese product Cheese n°2 = 3 g milk polar lipid fortified cheese product Cheese n°3 = 5 g milk polar lipid fortified cheese product | Other | 3g-5g milk polar lipid fortified-unfortified cheese product |
| Cheese n°3 - cheese n°1- cheese n°2Each subject will receive a single dose of cheese n°3, then cheese n°1 after a wash-out period of 4 weeks, then cheese n°2 after a wash-out period of 4 weeks. Cheese n°1 = unfortified cheese product Cheese n°2 = 3 g milk polar lipid fortified cheese product Cheese n°3 = 5 g milk polar lipid fortified cheese product | Other | 5g-unfortified-3g milk polar lipid fortified cheese product |
| Cheese n°3- cheese n°2 - cheese n°1Each subject will receive a single dose of cheese n°3, then cheese n°2 after a wash-out period of 4 weeks, then cheese n°1 after a wash-out period of 4 weeks. Cheese n°1 = unfortified cheese product Cheese n°2 = 3 g milk polar lipid fortified cheese product Cheese n°3 = 5 g milk polar lipid fortified cheese product | Other | 5g-3g milk polar lipid fortified-unfortified cheese product |
Primary outcome
Ileal sphingomyelin output
Time frame: up to Day 63
The total sphingomyelin output will be measured in the ileostomy fluids over 8 hours after the consumption of the 3 different test meals.
3 secondary outcomes
Plasma lipids and isotopic tracers
Time frame: A least Day 7, Day 35 and Day 63
Plasma glucose and insulin
Time frame: At least Day 7, Day 35 and Day 63
Energy expenditure and substrate oxidation with indirect calorimetry
Time frame: At least Day7, Day 35 and Day 63
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 27 Jan 2016.
- Derived from this study: PubMed 33857018Le Barz M, Vors C, Combe E, Joumard-Cubizolles L, Lecomte M, Joffre F, Trauchessec M, Pesenti S, Loizon E, Breyton AE, Meugnier E, Bertrand K, Drai J, Robert C, Durand A, Cuerq C, Gaborit P, Leconte N, Bernalier-Donadille A, Cotte E, Laville M, Lambert-Porcheron S, Ouchchane L, Vidal H, Malpuech-Brugere C, Cheillan D, Michalski MC. Milk polar lipids favorably alter circulating and intestinal ceramide and sphingomyelin species in postmenopausal women. JCI Insight. 2021 May 24;6(10):e146161. doi: 10.1172/jci.insight.146161.
- Derived from this study: PubMed 31189655Vors C, Joumard-Cubizolles L, Lecomte M, Combe E, Ouchchane L, Drai J, Raynal K, Joffre F, Meiller L, Le Barz M, Gaborit P, Caille A, Sothier M, Domingues-Faria C, Blot A, Wauquier A, Blond E, Sauvinet V, Gesan-Guiziou G, Bodin JP, Moulin P, Cheillan D, Vidal H, Morio B, Cotte E, Morel-Laporte F, Laville M, Bernalier-Donadille A, Lambert-Porcheron S, Malpuech-Brugere C, Michalski MC. Milk polar lipids reduce lipid cardiovascular risk factors in overweight postmenopausal women: towards a gut sphingomyelin-cholesterol interplay. Gut. 2020 Mar;69(3):487-501. doi: 10.1136/gutjnl-2018-318155. Epub 2019 Jun 12.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cheese n°1- cheese n°2 - cheese n°3, Cheese n°1- cheese n°3 - cheese n°2 and cheese n°2 - cheese n°1- cheese n°3 in people with Cardiometabolic Risk, run by Hospices Civils de Lyon at 2 sites in France.
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 4 inclusion and 4 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 27 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
Ileal sphingomyelin output (time frame: up to Day 63). 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 NCT02146339, which also lists 2 linked publications.
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 27 Jan 2016.