Cardiovascular DiseasesPhase 4NCT01178515
Low Fat Milk Intake and Cardio Vascular Risk (CVR) Indicators in Children
A Phase 4 study testing Modification of the content of fat in milk, Modification of the content of cows milk and Modification of the fat content of cows´ milk in people with Cardiovascular Diseases, run by Instituto Nacional de Salud Publica, Mexico at 1 site in Mexico.
Trial summary
Substituting whole milk intake for defatted milk will improve indicators of cardiovascular risk, i.e. total cholesterol, triglycerides, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL)cholesterol, apolipoproteins: ApoB100, Lp(a) and ApoA in a sample of Mexican children 6-13 years of age. Read more about this study
- Who is it for?
- Ages 6 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Modification of the content of fat in milk, Modification of the content of cows milk and Modification of the fat content of cows´ milk
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 650 participants
- Where
- 1 siteMexico
- Study dates
- Sep 2010to May 2011
- Phase
- Phase 4
- 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 6 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Attending selected boarding schools
Who cannot join
- No lactose intolerance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Low Fat Milk Intake on Cardiovascular Risk Indicators in Children 6-13 Years of Age
Substituting whole milk intake for defatted milk will improve indicators of cardiovascular risk, i.e. total cholesterol, triglycerides, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL)cholesterol, apolipoproteins: ApoB100, Lp(a) and ApoA in a sample of Mexican children 6-13 years of age.
Read the detailed description
Double blind trial in 600 children 6-13 years of age residing in 12 boarding schools. Schools will be randomized to distribute three types of milk namely: full fat milk (3% fat), partially defatted milk (2% fat) or defatted milk (1% fat) for 90 days of effective exposure (4 months total duration). Subjects will receive 400 mL of the corresponding milk every day (200 mL breakfast and 200 mL night meal) from Monday through Friday. During week ends they will eat a freely chosen diet at home. Milk intake will be measured every day. Diet by 24 h-recall. will be evaluated every month. Blood samples will be obtained at the beginning and at the end of the intervention.
- Conditions
- Cardiovascular Diseases
- Being tested
- Modification of the content of fat in milk, Modification of the content of cows milk, Modification of the fat content of cows´ milk
- Keywords
- epidemiological risk, diet, fat intake
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modification of the content of fat in milkOther
Also called Liconsa milk
Comparison of three levels of fat content in cow´s milk
Modification of the content of cows milkOther
Also called Liconsa low fat milk
Comparison of three levels of fat content in cows' milk
Modification of the fat content of cows´ milkOther
Also called Liconsa defatted milk
Comparison of three levels of fat content in cow´milk
| Study group | Role | What they receive |
|---|---|---|
| Full fat milk | Sham comparator | Full fat milk contain 3% fat Receives: Other: Modification of the content of fat in milk |
| Partially defatted milk | Experimental | Partially defatted milk contains 2% of fat Receives: Other: Modification of the content of cows milk |
| Defatted milk | Experimental | Defatted milk contains 1% fat Receives: Other: Modification of the fat content of cows´ milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular risk indicators
Cardiovascular risk is indicated by several determinations of blood fats namely: Total cholesterol, triglicerides, Low-density lipoprotein (LDL) and High density lipoprotein (HDL) cholesterol, lipoproteins: Apo a1,Apo B100 and Lp(a)
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2010 (estimated)
- Study startSep 2010
- Primary completionFeb 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 650 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Salud Publica, Mexico
- Sponsor type
- University, hospital or other
- Investigators
- Salvador Villalpando, MD, Ph D, Principal investigator, Instituto Nacional de Salud Publica, MexicoTeresa Shamah, M. Sc., Study chair, Instituto Nacional de Salud Publica, MexicoYaveth Lara, M Sc, Study chair, Instituto Nacional de Salud Publica, Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01178515
- Sponsor's protocol ID
- Milk, Cardiovas risk, children
- Other IDs
- 1-865-6540
- Status last verified
- Jun 2011
- First submitted
- 9 Aug 2010
- Last updated
- 27 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Stevens G, Dias RH, Thomas KJ, Rivera JA, Carvalho N, Barquera S, Hill K, Ezzati M. Characterizing the epidemiological transition in Mexico: national and subnational burden of diseases, injuries, and risk factors. PLoS Med. 2008 Jun 17;5(6):e125. doi: 10.1371/journal.pmed.0050125.
PubMed 18563960Berenson GS, Srinivasan SR, Bao W, Newman WP 3rd, Tracy RE, Wattigney WA. Association between multiple cardiovascular risk factors and atherosclerosis in children and young adults. The Bogalusa Heart Study. N Engl J Med. 1998 Jun 4;338(23):1650-6. doi: 10.1056/NEJM199806043382302.
PubMed 9614255Freedman DS. Clustering of coronary heart disease risk factors among obese children. J Pediatr Endocrinol Metab. 2002 Sep-Oct;15(8):1099-108. doi: 10.1515/JPEM.2002.15.8.1099.
PubMed 12387507Aguilar-Salinas CA, Gomez-Perez FJ, Rull J, Villalpando S, Barquera S, Rojas R. Prevalence of dyslipidemias in the Mexican National Health and Nutrition Survey 2006. Salud Publica Mex. 2010;52 Suppl 1:S44-53. doi: 10.1590/s0036-36342010000700008.
PubMed 20585729Corvalan C, Uauy R, Kain J, Martorell R. Obesity indicators and cardiometabolic status in 4-y-old children. Am J Clin Nutr. 2010 Jan;91(1):166-74. doi: 10.3945/ajcn.2009.27547. Epub 2009 Nov 18.
PubMed 19923378Villalpando S, Carrión C, Barquera S, Olaiz G, Robledo R. The body mass index is associated with hyperglycemia and alterations of some components of the metabolic syndrome in Mexican adolescents aged 10-19 years. Salud Pub Mex 2007; 49:s324-s330.
Webber LS, Srinivasan SR, Wattigney WA, Berenson GS. Tracking of serum lipids and lipoproteins from childhood to adulthood. The Bogalusa Heart Study. Am J Epidemiol. 1991 May 1;133(9):884-99. doi: 10.1093/oxfordjournals.aje.a115968.
PubMed 2028978
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Low Fat Milk Intake on Cardiovascular Risk Indicators in Children 6-13 Years of Age
- ClinicalTrials.gov ID
- NCT01178515
- Acronym / sponsor ID
- Milk, Cardiovas risk, children
- Conditions
- Cardiovascular Diseases
- Keywords
- epidemiological risk, diet, fat intake
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 650 participants (actual)
- Lead sponsor
- Instituto Nacional de Salud Publica, MexicoUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 10 Aug 2010 (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.
Substituting whole milk intake for defatted milk will improve indicators of cardiovascular risk, i.e. total cholesterol, triglycerides, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL)cholesterol, apolipoproteins: ApoB100, Lp(a) and ApoA in a sample of Mexican children 6-13 years of age.
Detailed description
Double blind trial in 600 children 6-13 years of age residing in 12 boarding schools. Schools will be randomized to distribute three types of milk namely: full fat milk (3% fat), partially defatted milk (2% fat) or defatted milk (1% fat) for 90 days of effective exposure (4 months total duration). Subjects will receive 400 mL of the corresponding milk every day (200 mL breakfast and 200 mL night meal) from Monday through Friday. During week ends they will eat a freely chosen diet at home. Milk intake will be measured every day. Diet by 24 h-recall. will be evaluated every month. Blood samples will be obtained at the beginning and at the end of the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Full fat milk | Sham comparator | Other: Modification of the content of fat in milkFull fat milk contain 3% fat |
| Partially defatted milk | Experimental | Other: Modification of the content of cows milkPartially defatted milk contains 2% of fat |
| Defatted milk | Experimental | Other: Modification of the fat content of cows´ milkDefatted milk contains 1% fat |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Attending selected boarding schools
Key exclusion criteria (1 listed)
- No lactose intolerance
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 |
|---|---|---|
| Modification of the content of fat in milkAlso: Liconsa milkComparison of three levels of fat content in cow´s milk | Other | Full fat milk |
| Modification of the content of cows milkAlso: Liconsa low fat milkComparison of three levels of fat content in cows' milk | Other | Partially defatted milk |
| Modification of the fat content of cows´ milkAlso: Liconsa defatted milkComparison of three levels of fat content in cow´milk | Other | Defatted milk |
Primary outcome
Cardiovascular risk indicators
Time frame: 4 months
Cardiovascular risk is indicated by several determinations of blood fats namely: Total cholesterol, triglicerides, Low-density lipoprotein (LDL) and High density lipoprotein (HDL) cholesterol, lipoproteins: Apo a1,Apo B100 and Lp(a)
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 Jun 2011.
- Background: PubMed 18563960Stevens G, Dias RH, Thomas KJ, Rivera JA, Carvalho N, Barquera S, Hill K, Ezzati M. Characterizing the epidemiological transition in Mexico: national and subnational burden of diseases, injuries, and risk factors. PLoS Med. 2008 Jun 17;5(6):e125. doi: 10.1371/journal.pmed.0050125.
- Background: PubMed 9614255Berenson GS, Srinivasan SR, Bao W, Newman WP 3rd, Tracy RE, Wattigney WA. Association between multiple cardiovascular risk factors and atherosclerosis in children and young adults. The Bogalusa Heart Study. N Engl J Med. 1998 Jun 4;338(23):1650-6. doi: 10.1056/NEJM199806043382302.
- Background: PubMed 12387507Freedman DS. Clustering of coronary heart disease risk factors among obese children. J Pediatr Endocrinol Metab. 2002 Sep-Oct;15(8):1099-108. doi: 10.1515/JPEM.2002.15.8.1099.
- Background: PubMed 20585729Aguilar-Salinas CA, Gomez-Perez FJ, Rull J, Villalpando S, Barquera S, Rojas R. Prevalence of dyslipidemias in the Mexican National Health and Nutrition Survey 2006. Salud Publica Mex. 2010;52 Suppl 1:S44-53. doi: 10.1590/s0036-36342010000700008.
- Background: PubMed 19923378Corvalan C, Uauy R, Kain J, Martorell R. Obesity indicators and cardiometabolic status in 4-y-old children. Am J Clin Nutr. 2010 Jan;91(1):166-74. doi: 10.3945/ajcn.2009.27547. Epub 2009 Nov 18.
- BackgroundVillalpando S, Carrión C, Barquera S, Olaiz G, Robledo R. The body mass index is associated with hyperglycemia and alterations of some components of the metabolic syndrome in Mexican adolescents aged 10-19 years. Salud Pub Mex 2007; 49:s324-s330.
- Background: PubMed 2028978Webber LS, Srinivasan SR, Wattigney WA, Berenson GS. Tracking of serum lipids and lipoproteins from childhood to adulthood. The Bogalusa Heart Study. Am J Epidemiol. 1991 May 1;133(9):884-99. doi: 10.1093/oxfordjournals.aje.a115968.
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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.
Salvador Villalpando, MD, Ph D principal investigator
Instituto Nacional de Salud Publica, Mexico
Teresa Shamah, M. Sc. study chair
Instituto Nacional de Salud Publica, Mexico
Yaveth Lara, M Sc study chair
Instituto Nacional de Salud Publica, Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Modification of the content of fat in milk, Modification of the content of cows milk and Modification of the fat content of cows´ milk in people with Cardiovascular Diseases, run by Instituto Nacional de Salud Publica, Mexico at 1 site in Mexico.
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 1 inclusion and 1 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 Jun 2011. 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 Mexico. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Cardiovascular risk indicators (time frame: 4 months). 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 NCT01178515, which also lists 7 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 Jun 2011.