Clinical trial NCT03640104: Individualized Dietary Intervention in Breastfeeding Women: Body Weight and Vitamin A Stores
Official title: Effect of an Individualized Dietary Intervention on the Body Composition and Vitamin A Status of Breastfeeding Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Vitamin A Deficiency
Dietary Modification
Breastfeeding
Keywords: Food-based intervention
postpartum weight management
hepatic retinol
Lead sponsor: Universidad de Sonora
Sponsor class: OTHER
Collaborators: name: Centro de Investigación en Alimentación y Desarrollo A.C.
name: University of Wisconsin, Madison
First posted: 2018-08-21
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Breast milk is the best food during the first 6mo of life because it offers multiple benefits for the mother-infant pair. An inadequate maternal diet during pregnancy can lead to excess weight gain, leading to negative health consequences for the dyad. In Mexico, an excess of body weight coexists with micronutrient deficiencies (double burden of malnutrition). Low vitamin A concentration has been observed in northwest Mexico, which can affect the human milk composition and increase the risk of VAD in breastfed babies. An individualized dietary intervention in the lactating woman will reduce body weight and improve vitamin A status. The objective is to assess the effect of an individualized dietary intervention during 3 months postpartum on body composition and vitamin A status of lactating women.

Detailed description: This protocol was approved by the Bioethics Committee of the Department of Medicine and Health Sciences of Universidad de Sonora. A randomized controlled trial will be carried out and participant women will be assigned by simple randomization 1:1 to either the intervention or control group, upon signing an informed consent. At baseline (2wk postpartum), anthropometric (weight, height, mid upper-arm circumference and triceps skinfold thickness) and body composition (DXA) measurements as well as the assessment of vitamin A status (serum and breastmilk retinol and the modified relative dose response) will be performed. The control group will receive only recommendations for a healthy diet in accordance with international standards and will be followed up every month to promote adherence and to assess their nutritional status. On the other hand, the intervention group will receive an individualized macronutrient meal equivalent menu, with nutritional consultations every two weeks. The dietary plan will include 1-1.5 g/kg body weight protein, 30% total fat (preferably mono and polyunsaturated fatty acids), and vitamin A sources (1300 RAE). After 3 months of intervention are completed, baseline measurements will be repeated. Statistical analysis will include descriptive stats and comparisons between groups (t-tests), significance will be defined as P \< 0.05.

Eligibility criteria: Inclusion Criteria:

* BMI ≥ 25
* Predominant breastfeeding
* Signed Informed Consent

Exclusion Criteria:

* Multiparity
* Alcohol, drugs, tobacco intake
* Use of dietary supplements
* Active infection (C reactive protein \> 6mg/L)
* External nutritional counseling
* Pregnancy during the study period
* Liver disease

Primary outcomes:
measure: Total Body weight
timeFrame: Baseline and 3 months after enrollment
measure: Vitamin A liver stores
timeFrame: Baseline and 3 months after enrollment
Secondary outcomes:
measure: Body fat mass
timeFrame: Baseline and 3 months after enrollment
measure: Retinol
timeFrame: Baseline and 3 months after enrollment
Other outcomes:
Locations:
city: Hermosillo
country: Mexico
facility: Universidad de Sonora
state: Sonora
Study officials:
affiliation: Universidad de Sonora
name: Veronica Lopez-Teros, Dr
role: PRINCIPAL_INVESTIGATOR
References: