<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03808207</url>
  </required_header>
  <id_info>
    <org_study_id>HM2018</org_study_id>
    <nct_id>NCT03808207</nct_id>
  </id_info>
  <brief_title>Human Milk Lipid Profile Assessment and Influences of Mother's Diet</brief_title>
  <official_title>Human Milk Lipid Profile Assessment and Influences of Mother's Diet Valutazione Del Profilo Lipidico Del Latte Materno e Della Sua Variazione in Relazione Alla Dieta Materna</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Università degli Studi di Ferrara</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Università degli Studi di Ferrara</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Human milk profile is unique and diet exerts a pivot role in determing its composition.&#xD;
&#xD;
      As a rule, nursing mothers do not receive specific nutritional indications aimed at improving&#xD;
      the lipid profile of milk, despite the scientific evidence in favor of the importance of DHA&#xD;
      in the infant's diet.&#xD;
&#xD;
      The research aims to determine the effect of a dietary counseling specifically targeted at&#xD;
      increasing the intake of fatty acids ω3 (DHA, EPA and ALA) on the lipid profile of breast&#xD;
      milk, in order to identify effective and viable nutrition claims for breastfeeding women.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Breast milk, with its unique and inimitable characteristics, is the ideal feeding for&#xD;
      full-term babies. The maternal diet strongly influences the composition of milk, in&#xD;
      particular, its lipid proflie, which provides about 50% of the infant's energy needs. In&#xD;
      particular, the polyunsaturated fatty acid fraction may varies according ethnic origin and&#xD;
      diet habit.&#xD;
&#xD;
      Docosahexaenoic acid or DHA (22: 6 n-3), a long chain fatty acid from the omega 3 series,&#xD;
      plays a fundamental role in neurogenesis and neurotransmission as well as in vision, as it is&#xD;
      present in both brain, particularly in neural synapses, and in retinal photoreceptors. In&#xD;
      particular, the brain grows rapidly from birth to the first year of life, and this growth&#xD;
      must be supported by the adequate and balanced intake of all fatty acids; among these we have&#xD;
      seen that DHA has a priority role. Observational studies have shown that higher&#xD;
      concentrations in breast milk and / or maternal and / or neonatal DHA blood are associated&#xD;
      with greater visual acuity, language development, psychomotor development, attention and&#xD;
      higher IQ scores in children. The paucity of DHA in the maternal diet of Western countries,&#xD;
      and the low conversion rate of α-linolenic acid or ALA (18: 3 n-3) in DHA in humans babies,&#xD;
      may result in an insufficient supply for the newborn brain.&#xD;
&#xD;
      Most of the prospective studies carried out in this area have evaluated the effects of&#xD;
      maternal supplementation of fish oils, algal oils, chia oil, linseed oil. At present, the&#xD;
      positive association between the frequency of fish consumption and DHA levels in breast milk&#xD;
      has only been evaluated in retrospective studies.&#xD;
&#xD;
      On these basis, the purpose of this randomized clinical trial is the evaluation of the&#xD;
      efficacy of a dietary counseling specifically aimed at increasing the intake of ALA and its&#xD;
      long-chain derivatives on the lipid profile of breast milk. Women in the intervention group&#xD;
      will be provided an informative scheme on food options with the highest content of the&#xD;
      aforementioned polyunsaturated fatty acids. The expected result, at 3 months after delivery,&#xD;
      in the intervention group is an increase of DHA in breast milk 80% higher than the value&#xD;
      found in the control group (women on a free diet). Dietary habits at enrollment and actual&#xD;
      intakes will be recorded for 1 week before the two milk samplings. The research is also aimed&#xD;
      at verifying the efficacy of a nutritional educational intervention, without strict&#xD;
      preordained schemes, and above all without the aid of dietary supplements.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 6, 2018</start_date>
  <completion_date type="Anticipated">October 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">August 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Blind randomized clinical trial</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The lipid profile will be assessed by an external investigator who is blind for the dietary advices and choices of the single patient. Milk samples are assigned a progressive numerical code.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Human milk lipid profile assesment after 3 months of DHA/ALA diet enrichment</measure>
    <time_frame>80 days</time_frame>
    <description>Lipid profile assesment of human milk at 10 days and 3 months after delivery. Evaluation of the effect of DHA/ALA diet enrichment during the study period. Measurement of total fat (g/100 ml), saturated fatty acids, monounsaturated fatty and polyunsaturated fatty acids concentration (mg/100 ml), and specifically LA, ALA, ARA, DHA and EPA concentration (mg/100 ml) will be performed with gas chromatograph coupled to a MS / MS mass spectrometer.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Lipid profile characteristics in human milk of mothers delivering preterm or term infants</measure>
    <time_frame>80 days</time_frame>
    <description>Lipid profile characteristics in human milk of mothers who delivered 34-36 weeks and 6 days or &gt;37 weeks gestational age infants.&#xD;
Measurement of total fat (g/100 ml), saturated fatty acids, monounsaturated fatty and polyunsaturated fatty acids concentration (mg/100 ml), and specifically LA, ALA, ARA, DHA and EPA concentration (mg/100 ml) will be performed with gas chromatograph coupled to a MS / MS mass spectrometer.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Breastfeeding</condition>
  <condition>Human Milk</condition>
  <condition>Diet Habit</condition>
  <condition>Fatty Acid</condition>
  <condition>Infant Growth</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Increase of the average intake of dietary DHA: dietary advices concerning the concentration of docosahexaenoic acid (DHA) in several foods; the recommended daily or weekly intake of different food options (animal, vegetal) in order to reach the average intake of 300-350 mg DHA/day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No specific dietary advice; Only endorsement and promotion of breastfeeding.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dietary counseling and DHA dietary increase in breastfeeding mothers</intervention_name>
    <description>Specific dietary advices in order to increase the daily/weekly intake of docosahexaenoic acid of breastfeeding mothers for the first 3 months after delivery</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women who have delivered at &gt; 33 weeks GA&#xD;
&#xD;
          -  ongoing breastfeeding&#xD;
&#xD;
          -  consent received&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  contraindications to breastfeeding&#xD;
&#xD;
          -  neonatal malformations or genetic anomalies&#xD;
&#xD;
          -  language barrier&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>mother's milk; breastfeeding status</gender_description>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Silvia Fanaro, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical Science Department, University of Ferrara, Italy</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Silvia Fanaro, MD</last_name>
    <phone>+390532236014</phone>
    <email>fnrslv@unife.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>UO Neonatal Intensive Care Unit and Neonatology</name>
      <address>
        <city>Ferrara</city>
        <zip>44124</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Silvia Fanaro, MD</last_name>
    </contact>
    <contact_backup>
      <last_name>Alice Gollini, Student</last_name>
    </contact_backup>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>October 1, 2018</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>January 14, 2019</last_update_submitted>
  <last_update_submitted_qc>January 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Università degli Studi di Ferrara</investigator_affiliation>
    <investigator_full_name>Fanaro Silvia</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Docosahexaenoic acid</keyword>
  <keyword>LcPufas</keyword>
  <keyword>Diet</keyword>
  <keyword>Human milk</keyword>
  <keyword>gas chromatography</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 18, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/07/NCT03808207/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 18, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/07/NCT03808207/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03808207
org study id: HM2018
nct id: NCT03808207
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Human milk profile is unique and diet exerts a pivot role in determing its composition.

      As a rule, nursing mothers do not receive specific nutritional indications aimed at improving
      the lipid profile of milk, despite the scientific evidence in favor of the importance of DHA
      in the infant's diet.

      The research aims to determine the effect of a dietary counseling specifically targeted at
      increasing the intake of fatty acids ω3 (DHA, EPA and ALA) on the lipid profile of breast
      milk, in order to identify effective and viable nutrition claims for breastfeeding women.
Breast milk, with its unique and inimitable characteristics, is the ideal feeding for
      full-term babies. The maternal diet strongly influences the composition of milk, in
      particular, its lipid proflie, which provides about 50% of the infant's energy needs. In
      particular, the polyunsaturated fatty acid fraction may varies according ethnic origin and
      diet habit.

      Docosahexaenoic acid or DHA (22: 6 n-3), a long chain fatty acid from the omega 3 series,
      plays a fundamental role in neurogenesis and neurotransmission as well as in vision, as it is
      present in both brain, particularly in neural synapses, and in retinal photoreceptors. In
      particular, the brain grows rapidly from birth to the first year of life, and this growth
      must be supported by the adequate and balanced intake of all fatty acids; among these we have
      seen that DHA has a priority role. Observational studies have shown that higher
      concentrations in breast milk and / or maternal and / or neonatal DHA blood are associated
      with greater visual acuity, language development, psychomotor development, attention and
      higher IQ scores in children. The paucity of DHA in the maternal diet of Western countries,
      and the low conversion rate of α-linolenic acid or ALA (18: 3 n-3) in DHA in humans babies,
      may result in an insufficient supply for the newborn brain.

      Most of the prospective studies carried out in this area have evaluated the effects of
      maternal supplementation of fish oils, algal oils, chia oil, linseed oil. At present, the
      positive association between the frequency of fish consumption and DHA levels in breast milk
      has only been evaluated in retrospective studies.

      On these basis, the purpose of this randomized clinical trial is the evaluation of the
      efficacy of a dietary counseling specifically aimed at increasing the intake of ALA and its
      long-chain derivatives on the lipid profile of breast milk. Women in the intervention group
      will be provided an informative scheme on food options with the highest content of the
      aforementioned polyunsaturated fatty acids. The expected result, at 3 months after delivery,
      in the intervention group is an increase of DHA in breast milk 80% higher than the value
      found in the control group (women on a free diet). Dietary habits at enrollment and actual
      intakes will be recorded for 1 week before the two milk samplings. The research is also aimed
      at verifying the efficacy of a nutritional educational intervention, without strict
      preordained schemes, and above all without the aid of dietary supplements.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Blind randomized clinical trial
primary purpose: Other
masking: Single (Outcomes Assessor)
masking description: The lipid profile will be assessed by an external investigator who is blind for the dietary advices and choices of the single patient. Milk samples are assigned a progressive numerical code.
measure: Human milk lipid profile assesment after 3 months of DHA/ALA diet enrichment
time frame: 80 days
description: Lipid profile assesment of human milk at 10 days and 3 months after delivery. Evaluation of the effect of DHA/ALA diet enrichment during the study period. Measurement of total fat (g/100 ml), saturated fatty acids, monounsaturated fatty and polyunsaturated fatty acids concentration (mg/100 ml), and specifically LA, ALA, ARA, DHA and EPA concentration (mg/100 ml) will be performed with gas chromatograph coupled to a MS / MS mass spectrometer.
measure: Lipid profile characteristics in human milk of mothers delivering preterm or term infants
time frame: 80 days
description: Lipid profile characteristics in human milk of mothers who delivered 34-36 weeks and 6 days or >37 weeks gestational age infants.
Measurement of total fat (g/100 ml), saturated fatty acids, monounsaturated fatty and polyunsaturated fatty acids concentration (mg/100 ml), and specifically LA, ALA, ARA, DHA and EPA concentration (mg/100 ml) will be performed with gas chromatograph coupled to a MS / MS mass spectrometer.
arm group label: Intervention group
arm group type: Experimental
description: Increase of the average intake of dietary DHA: dietary advices concerning the concentration of docosahexaenoic acid (DHA) in several foods; the recommended daily or weekly intake of different food options (animal, vegetal) in order to reach the average intake of 300-350 mg DHA/day
arm group label: Control group
arm group type: No Intervention
description: No specific dietary advice; Only endorsement and promotion of breastfeeding.
intervention type: Other
intervention name: Dietary counseling and DHA dietary increase in breastfeeding mothers
description: Specific dietary advices in order to increase the daily/weekly intake of docosahexaenoic acid of breastfeeding mothers for the first 3 months after delivery
arm group label: Intervention group
criteria: 
gender: Female
gender based: Yes
gender description: mother's milk; breastfeeding status
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Silvia Fanaro, MD
role: Principal Investigator
affiliation: Medical Science Department, University of Ferrara, Italy
last name: Silvia Fanaro, MD
phone: +390532236014
email: fnrslv@unife.it
facility: 
status: Recruiting
contact: 
contact backup: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Università degli Studi di Ferrara
investigator full name: Fanaro Silvia
investigator title: Assistant Professor
sharing ipd: No
provided document: 
provided document: 