Overweight and Obesity Clinical Trial
Official title:
Effect of an Individualized Dietary Intervention on the Body Composition and Vitamin A Status of Breastfeeding Women
Verified date | April 2021 |
Source | Universidad de Sonora |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | February 7, 2020 |
Est. primary completion date | February 7, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Mexico | Universidad de Sonora | Hermosillo | Sonora |
Lead Sponsor | Collaborator |
---|---|
Universidad de Sonora | Centro de Investigación en Alimentación y Desarrollo A.C., University of Wisconsin, Madison |
Mexico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total Body weight | Difference in change (between baseline and final body weight within groups) between the intervention and control group, respectively | Baseline and 3 months after enrollment | |
Primary | Vitamin A liver stores | Stores are calculated as the DR/R ratio. The outcome will be calculated as the difference in change (between baseline and final VA stores within groups) between the intervention and control group, respectively | Baseline and 3 months after enrollment | |
Secondary | Body fat mass | Difference in change (between baseline and final body fat mass within groups) between the intervention and control group, respectively | Baseline and 3 months after enrollment | |
Secondary | Retinol | Difference in change (between baseline and final retinol concentration within groups) between the intervention and control group, respectively | Baseline and 3 months after enrollment |
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