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Study of formula milk with breast milk-derived new ingredient (nicotinamide mononucleotide) on energy metabolism of baby: multicenter, double-blinded, randomized, commercial product-controlled trial

Study of formula milk with breast milk-derived new ingredient (nicotinamide mononucleotide) on energy metabolism of baby: multicenter, double-blinded, randomized, commercial product-controlled trial - SMILE-Baby study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000054184
Enrollment
44
Registered
2024-04-18
Start date
2024-04-18
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy infant

Interventions

Study infant milk fomula group - consume study infant milk fomula containing NMN (nutritional composition other than NMN is identical to commercial infant milk fomula) for 4 weeks after discharge fr

Sponsors

Juntendo University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Infants who are born between 28 and 37 weeks of gestation and their mothers aged of 18 years or older 2. Infants who are hospitalized but healthy and expected to have a normal life after discharge from hospital, and their mother 3. Mixed or artificially-fed infants and their mothers 4. Infants for whom the nutritional composition of infant milk fomula is suitable as a supplement to insufficient breast milk, and their mother 5. Infants whose mother and regal representatives (persons with parental authority) give the consent to participate in this study in written form after full explanation and full understanding of this study, and their mother theirselves

Exclusion criteria

Exclusion criteria: 1. Infants with serious infection and their mothers 2. Infants with serious diseases and their mothers 3. Infants with other conditions that the responsible investigator or subinvestigators judge inappropriate to participate in this study

Design outcomes

Primary

MeasureTime frame
Blood NAD concentration

Secondary

MeasureTime frame
1. NMN metabolite in blood or urine of infants 2. Blood biochemical laboratory test values of infants 3. Body measurements (hight, weight, etc.) 4. Frequeycy of adverse events in infants that is considered to be related with the consumption of the study milk

Countries

Japan

Contacts

Public ContactArata Yoneda

EviPRO Co., Ltd. Clinical Study Support Division

yoneda_arata@evipro.co.jp03-5829-4110

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026