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Mediterranean Diet for Obese Lactating Women

N/A

Waitlist Available

Led By Clark Sims, PhD

Research Sponsored by Arkansas Children's Hospital Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the change in breast milk fat concentration will be assessed by mid-infrared spectroscopy by measuring the concentration before the participants begin the dietary intervention, 2 weeks into the intervention, and at the end of the 4-week intervention.

Awards & highlights

Study Summary

This trial looks at how a Mediterranean diet for moms affects their breast milk content and their infant's growth.

Who is the study for?

This trial is for breastfeeding moms who are 18 or older, less than 4.5 months postpartum, with a BMI between 30-50. They must be exclusively breastfeeding and plan to continue for at least 6 months. Moms should have a breast pump and not use drugs, tobacco, alcohol, or medications that aren't safe for breastfeeding.Check my eligibility

What is being tested?

The study tests if following a Mediterranean diet for four weeks can change the composition of breast milk in obese lactating women. The mothers' meals will adhere to this diet pattern and researchers will monitor any changes in their infants' growth during the study period.See study design

What are the potential side effects?

Since this intervention involves dietary changes rather than medication, side effects may include typical reactions to dietary adjustments such as changes in digestion or food sensitivities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the change in breast milk fat concentration will be assessed by mid-infrared spectroscopy by measuring the concentration before the participants begin the dietary intervention, 2 weeks into the intervention, and at the end of the 4-week intervention.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the change in breast milk fat concentration will be assessed by mid-infrared spectroscopy by measuring the concentration before the participants begin the dietary intervention, 2 weeks into the intervention, and at the end of the 4-week intervention.

This trial's timeline: 3 weeks for screening, Varies for treatment, and the change in breast milk fat concentration will be assessed by mid-infrared spectroscopy by measuring the concentration before the participants begin the dietary intervention, 2 weeks into the intervention, and at the end of the 4-week intervention. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in breast milk fat concentration by mid-infrared spectroscopy

Side effects data

From 2022 Phase 1 & 2 trial • 33 Patients • NCT04534738

Shortness of breath

Fainting

Pneumonia

Neutropenic fever

Bacteremia

Cellulitis of the chest wall

100%

80%

60%

40%

20%

Study treatment Arm

Mediterranean Diet

Usual Care

Trial Design

1Treatment groups

Experimental Treatment

Group I: Mediterranean Meal PlanExperimental Treatment1 Intervention

This is a single arm study in which participants will receive meals that follow a Mediterranean diet plan for 4 weeks. Breast milk samples will be collected before, during, and after the intervention period.

Do I qualify?Apply below to find out