The Bottle Optimization Testing Tiny Little Eaters Study

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan
Study ID
NCT07665983
Status
Recruiting
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Conditions

  • Childhood Obesity

Eligibility Criteria

Sex
ALL
Age
4 Months - N/A
Healthy Volunteers
Accepted

Interventions

  • Feeding — BEHAVIORAL
    Following a baseline day (Day 1) in which infants are fed with their typical nipple, infants are exposed to a commercially available nipple with a 30 percent reduced flow rate for three consecutive days (Days 2-4).

Study Details

The researchers will study how babies respond to bottle nipples with different flow rates over a few days, and how this may affect how much milk they drink, their feeding patterns, and their sleep.

Key Dates

Start date
Jun 30, 2026
Status verified
Jun 2026
Primary completion
Aug 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
440 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Mother-infant dyad
    Each mother-infant dyad serves as its own control.

Primary Outcome Measure

Change in milk/formula intake (Δ^(S-T)) [ Time Frame: From baseline to the end of the slower flow feeding phase (approximately 4 days later) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
Bryanne Caldwell
[email protected]
734-647-8100
Amanda Crandall, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Michigan· Ann Arbor, MI

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