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
Phase: NA
Conditions: Breastfeeding, Human Milk, Diet Habit, Fatty Acid, Infant Growth
Sponsor: Università degli Studi di Ferrara

Human Milk Lipid Profile Assessment and Influences of Mother's Diet
STUDY SYNOPSIS
1. Title
Evaluation of the lipid profile of breast milk and its variation in relation to the maternal diet.
Randomized, controlled, blinded clinical trial.
2. Eligibility (inclusion criteria)
Women within 15 post-partum days who have delivered newborns of EG≥ 34 weeks.
Written informed consent given.
3. Exclusion criteria
Impossibility / lack of breastfeeding will
Contraindications to breastfeeding
Genetic diseases / neonatal malformations
Linguistic barriers
4. Study design
Randomized, controlled, single-blinded clinical trial.
5. Treatment
Nutritional indications to increase the dietary consumption of foods naturally rich in DHA and ALA.
6. Scheduled number
24 women
7. Primary objective
Evaluation of the lipid profile of breast milk, at time 0 (10-15 days postpartum) and at time 1
(about 3 months postpartum). 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.
Evaluation of differences at time 1 among women on a free diet and the group randomized to specific
dietary advice aimed at increasing the intake of fatty acids ω3 (DHA, EPA and ALA) with the diet.
8. Secondary objectives
Evaluation of the correlation between real dietary intake (food diary) and lipid profile of breast
milk,
Evaluation of differences in milk lipid profile of mothers who gave birth to term or pre-term (34-36
weeks).
9. Security parameters
anthropometric growth of the infant during the study
10. Rational
As a rule, nursing mothers are not given 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 to increase
the dietary intake of fatty acids ω3 (DHA, EPA and ALA) on the lipid profile of breast milk after 3
months; to identify effective and feasible nutrition claims for breastfeeding women.
1
Ethical Committee approval 18/07/2018

Statistical evaluation
Calculation of sample size
Assuming from literature data [16] that at T0 the dosage of DHA in human milk is 0.21 ― 0.1 (unit of
measure) in both arms and that dietary indications lead to a 60% increase in T1 compared to T0. With
a power of 80% and a significance level of 0.05, the minimum number per group is 11 women. Assuming
more than 10-15% of dropouts during follow-up, the study aims to enroll 12 women per arm, for a
total number of 24 subjects.
Randomization
Randomization will be performed with the Random Number Generator of the Emilia Romagna Region
Website (http://wwwservizi.regione.emilia-romagna.it/generatore/)
Statistical analysis plan
Results will be reported through averages and standard deviations (ds) for numerical variables with
approximately normal distribution or through more robust measures such as median and inter-quartile
range in case of non-normal distribution. The distributions of the categorical variables will
instead be described by absolute frequencies and percentages. The two treatment groups will be
compared with baseline characteristics to evaluate the balance of randomization. In this regard, the
Student's t test or non-parametric equivalent will be used, Wilcoxon-Mann-Whitney test for
continuous variables, while Pearson's χ2 test or Fisher's exact test for categorical variables may
be used.
For the evaluation of the primary endpoint, tests for repeated measurements will be used: t-test or
Wilcoxon test for paired data depending on the distribution of the variables. Furthermore, the
relationship between DHA variation in diet and the consequent variation of fatty acids contained in
breast milk will be investigated, through correlation measures such as Pearson's index or Spearman's
non-parametric correlation. Finally, the variation of DHA in human milk will be compared in the
subgroups defined by the other variables collected as the pre-term birth, in order to identify those
factors that can act as effect modifiers of the diet. The same statistical tests described above
will be used for these comparisons. Statistical significance is set at a level α = 0.05 and analyzes
will be performed using Stata 13 statistical software (StataCorp, 2013, College Station, TX).
Ethical Committee approval 18/07/2018