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Lactation Cookie Study

NCT04805008 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 176

Last updated 2022-01-21

No results posted yet for this study

Summary

Lactation cookies contain ingredients thought to increase breast milk production. Although these cookies are widely purchased and consumed with the intention to increase breast milk supply, no scientific investigation has explored the effects of lactation cookies on human breast milk production.

This study will evaluate the effects of a lactation cookie in breast milk production, relative to cookies without ingredients thought to increase breast milk production in exclusively breastfeeding mothers of healthy, term babies.

Conditions

  • Breastfeeding

Interventions

OTHER

Lactation cookies

1 serving of 2 OZ of cookies per day for 30 consecutive days. These cookies will contain ingredients thought to increase breast milk production.

OTHER

Control cookies

1 serving of 2 OZ of cookies per day for 30 consecutive days. The cookies will not contain ingredients thought to increase breast milk production.

Sponsors & Collaborators

  • University of Florida

    collaborator OTHER

  • Indiana University

    lead OTHER

Principal Investigators

  • Ana Palacios, MD, PhD · Indiana University, Bloomington

  • David Allison, PhD · Indiana University, Bloomington

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-18
Primary Completion
2021-12-17
Completion
2021-12-17

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04805008 on ClinicalTrials.gov