Cardiometabolic RiskVALOBAB-CNCT02099032
Milk Polar Lipids Consumption, Lipid Metabolism, and Inflammation in Menopausal Women
A study testing 3g milk polar lipid fortified cheese consumption, 5g milk polar lipid fortified cheese consumption and Unfortified cheese product consumption 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 Up to 75 years, women only
- Conditions the study is for
- Cardiometabolic Risk
- What is being tested?
- 3g milk polar lipid fortified cheese consumption, 5g milk polar lipid fortified cheese consumption and Unfortified cheese product consumption
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 2 sitesFrance
- Study dates
- Mar 2014to Jan 2016
- 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 Up to 75 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Menopausal women
- Of less than 75 years old- Body Mass Index of 25 to 35 kg/m2
- Waist circumference greater than 80 cm
- Normal (or not clinically significant) glycemic and lipid parameters
Who cannot join
- Dairy products allergy or intolerance
- Smokers (more than five cigarettes/day)
- HDL cholesterol greater than 1.5 mmol/L
- Medication that could interfere with lipid metabolism or intestinal microbiota (for example, no antibiotics within the 2 months before the study)
- Hormone replacement treatment for menopause
Trial locations and contacts
2 sites in 1 country.
France2 sites
Université d'Auvergne-Laboratoire de Nutrition Humaine
Clermont-Ferrand, 63001
Centre de Recherche en Nutrition Humaine Rhône-Alpes
Pierre-Bénite, 69310
About this study
Official title: Influence of Milk Polar Lipids Intake on Lipid Metabolism, Body Composition, Inflammation and Intestinal Microbiota in Menopausal Women
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.
Read more
The purpose of this research is to study plasma cholesterol variation after daily intake of milk polar lipids-fortified cheese products. The volunteers will have to consume 100 g of cheese product during four weeks instead of their usual cheese products.
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
- 3g milk polar lipid fortified cheese consumption, 5g milk polar lipid fortified cheese consumption, Unfortified cheese product consumption
- 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.
3g milk polar lipid fortified cheese consumptionOther
Women will have to consume daily 100g of a 3g milk polar lipid fortified cheese product instead of usual cheese products during four weeks.
5g milk polar lipid fortified cheese consumptionOther
Women will have to consume daily 100g of a 5 g milk polar lipid fortified cheese product instead of usual cheese products during four weeks.
Unfortified cheese product consumptionOther
Women will have to consume daily 100g of a unfortified cheese product instead of usual cheese products during four weeks
| Study group | Role | What they receive |
|---|---|---|
| 3g milk polar lipid fortified cheese product | Experimental | Women will have to consume daily 100g of a cheese product instead of usual cheese products during four weeks. Receives: Other: 3g milk polar lipid fortified cheese consumption |
| 5 g milk polar lipid fortified cheese product | Experimental | Women will have to consume daily 100g of a cheese product instead of usual cheese products during four weeks. Receives: Other: 5g milk polar lipid fortified cheese consumption |
| Unfortified cheese product | Placebo comparator | Women will have to consume daily 100g of a cheese product instead of usual cheese products during four weeks Receives: Other: Unfortified cheese product consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total plasma cholesterol
Total plasma cholesterol will be measured fasting before and after the four weeks of cheese product intake.
Measured: Day 0 and Day 28
Secondary outcomes (6)
Plasma lipids
Plasma lipids will be measured before and after the four weeks of cheese product intake. Fasting and postprandial measurements over 8 hours depending on parameters (time 60-120-180-240-270-300-360-420-480 minutes)
Measured: Day 0 and Day 28
Plasma glucose and insulin
Plasma glucose and insulin will be measured before and after the four weeks of cheese product intake. Fasting and postprandial measurements over 8 hours.
Measured: Day 0 and Day 28
Inflammatory markers
Inflammatory markers will be measured before and after the four weeks of cheese product intake. Fasting and postprandial measurements over 8 hours depending on parameters
Measured: Day 0 and Day 28
Body composition measurement with bioimpedancemetry
Body composition will be measured fasting before and after the four weeks of cheese product intake.
Measured: Day 0 and Day 28
Energy expenditure and substrate oxidation with indirect calorimetry
Energy metabolism will be measured before and after the four weeks of cheese product intake. Fasting and during all the postprandial period (480 minutes)
Measured: Day 0 and Day 28
Intestinal microbiota with molecular approach
Stools will be collected at home before and after the four weeks of cheese product intake.
Measured: before and after the four weeks of cheese product intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionJan 2016
- Study completionJan 2016
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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 59 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
- NCT02099032
- Sponsor's protocol ID
- 2013.821
- Acronym
- VALOBAB-C
- Status last verified
- Jan 2021
- First submitted
- 25 Mar 2014
- Last updated
- 27 Jan 2021
- 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 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Milk Polar Lipids Intake on Lipid Metabolism, Body Composition, Inflammation and Intestinal Microbiota in Menopausal Women
- ClinicalTrials.gov ID
- NCT02099032
- Acronym / sponsor ID
- VALOBAB-C / 2013.821
- Conditions
- Cardiometabolic Risk
- Keywords
- nutrition, milk, polar lipids, cardiometabolic risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 28 Mar 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.
The purpose of this research is to study plasma cholesterol variation after daily intake of milk polar lipids-fortified cheese products. The volunteers will have to consume 100 g of cheese product during four weeks instead of their usual cheese products.
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
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 3g milk polar lipid fortified cheese product | Experimental | Other: 3g milk polar lipid fortified cheese consumptionWomen will have to consume daily 100g of a cheese product instead of usual cheese products during four weeks. |
| 5 g milk polar lipid fortified cheese product | Experimental | Other: 5g milk polar lipid fortified cheese consumptionWomen will have to consume daily 100g of a cheese product instead of usual cheese products during four weeks. |
| Unfortified cheese product | Placebo comparator | Other: Unfortified cheese product consumptionWomen will have to consume daily 100g of a cheese product instead of usual cheese products during four weeks |
Who may qualify
- Ages
- Up to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Menopausal women
- Of less than 75 years old- Body Mass Index of 25 to 35 kg/m2
- Waist circumference greater than 80 cm
- Normal (or not clinically significant) glycemic and lipid parameters
Key exclusion criteria (5 listed)
- Dairy products allergy or intolerance
- Smokers (more than five cigarettes/day)
- HDL cholesterol greater than 1.5 mmol/L
- Medication that could interfere with lipid metabolism or intestinal microbiota (for example, no antibiotics within the 2 months before the study)
- Hormone replacement treatment for menopause
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 |
|---|---|---|
| 3g milk polar lipid fortified cheese consumptionWomen will have to consume daily 100g of a 3g milk polar lipid fortified cheese product instead of usual cheese products during four weeks. | Other | 3g milk polar lipid fortified cheese product |
| 5g milk polar lipid fortified cheese consumptionWomen will have to consume daily 100g of a 5 g milk polar lipid fortified cheese product instead of usual cheese products during four weeks. | Other | 5 g milk polar lipid fortified cheese product |
| Unfortified cheese product consumptionWomen will have to consume daily 100g of a unfortified cheese product instead of usual cheese products during four weeks | Other | Unfortified cheese product |
Primary outcome
Total plasma cholesterol
Time frame: Day 0 and Day 28
Total plasma cholesterol will be measured fasting before and after the four weeks of cheese product intake.
6 secondary outcomes
Plasma lipids
Time frame: Day 0 and Day 28
Plasma glucose and insulin
Time frame: Day 0 and Day 28
Inflammatory markers
Time frame: Day 0 and Day 28
Body composition measurement with bioimpedancemetry
Time frame: Day 0 and Day 28
Energy expenditure and substrate oxidation with indirect calorimetry
Time frame: Day 0 and Day 28
Intestinal microbiota with molecular approach
Time frame: before and after the four weeks of cheese product intake
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 2021.
- 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 3g milk polar lipid fortified cheese consumption, 5g milk polar lipid fortified cheese consumption and Unfortified cheese product consumption 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 5 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 2021. 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. Some participants in this study may receive a placebo. 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?
Total plasma cholesterol (time frame: Day 0 and Day 28). 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 NCT02099032, 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 2021.