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Individualized Dietary Intervention in Breastfeeding Women: Body Weight and Vitamin A Stores

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ClinicalTrials.gov Identifier: NCT03640104
Recruitment Status : Not yet recruiting
First Posted : August 21, 2018
Last Update Posted : August 22, 2018
Sponsor:
Collaborators:
Centro de Investigación en Alimentación y Desarrollo A.C.
University of Wisconsin, Madison
Information provided by (Responsible Party):
Verónica López Teros, Universidad de Sonora

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.

Condition or disease Intervention/treatment Phase
Overweight and Obesity Vitamin A Deficiency Dietary Modification Breastfeeding Behavioral: Intervention-Nutrition guidelines Behavioral: Nutrition guidelines Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of an Individualized Dietary Intervention on the Body Composition and Vitamin A Status of Breastfeeding Women
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : August 16, 2019


Arm Intervention/treatment
Experimental: Intervention-Nutrition guidelines
Subjects will receive an individualized dietary plan according to their nutritional status, socioeconomic and cultural preferences. Protein intake 1-1.5g/kg body weight; 30% fat (mono and polyunsaturated fatty acids), vitamin A sources (1300 RAE). Each subject will have 7 interchangeable options for every meal time, all equivalent in macronutrient content, and every two weeks a new menu will be provided by a nutritionist.
Behavioral: Intervention-Nutrition guidelines
Subjects will receive an individualized dietary plan according to their nutritional status, socioeconomic and cultural preferences. Protein intake 1-1.5g/kg body weight; 30% fat (mono and polyunsaturated fatty acids), vitamin A sources (1300 RAE). Each subject will have 7 interchangeable options for every meal time, all equivalent in macronutrient content, and every two weeks a new menu will be provided by a nutritionist.

Nutrition Guidelines
Participants will receive general nutritional recommendations according to international standards
Behavioral: Nutrition guidelines
Nutritional recommendations based on international guidelines




Primary Outcome Measures :
  1. Total Body weight [ Time Frame: Baseline and 3 months after enrollment ]
    Difference in change (between baseline and final body weight within groups) between the intervention and control group, respectively

  2. Vitamin A liver stores [ Time Frame: Baseline and 3 months after enrollment ]
    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


Secondary Outcome Measures :
  1. Body fat mass [ Time Frame: Baseline and 3 months after enrollment ]
    Difference in change (between baseline and final body fat mass within groups) between the intervention and control group, respectively

  2. Retinol [ Time Frame: Baseline and 3 months after enrollment ]
    Difference in change (between baseline and final retinol concentration within groups) between the intervention and control group, respectively



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03640104


Contacts
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Contact: Veronica Lopez-Teros, Dr +52(662)1224955 veronica.lopez@unison.mx
Contact: Ana T Limon-Miro, cDr +52(662)296132 analimonmiro@gmail.com

Locations
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Mexico
Universidad de Sonora Not yet recruiting
Hermosillo, Sonora, Mexico, 83000
Contact: Veronica Lopez-Teros, Dr         
Sponsors and Collaborators
Universidad de Sonora
Centro de Investigación en Alimentación y Desarrollo A.C.
University of Wisconsin, Madison
Investigators
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Principal Investigator: Veronica Lopez-Teros, Dr Universidad de Sonora

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Responsible Party: Verónica López Teros, Research professor, Universidad de Sonora
ClinicalTrials.gov Identifier: NCT03640104     History of Changes
Other Study ID Numbers: VLT-001
First Posted: August 21, 2018    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Verónica López Teros, Universidad de Sonora:
Food-based intervention
postpartum weight management
hepatic retinol

Additional relevant MeSH terms:
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Overweight
Vitamin A Deficiency
Night Blindness
Body Weight
Signs and Symptoms
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vision Disorders
Eye Diseases
Vitamins
Vitamin A
Retinol palmitate
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents