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

UMIN ID: UMIN000054184

Registered date:18/04/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy infant
• Date of first enrollment: 2024/04/18
• Target sample size: 44
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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 from hospital
Control infant milk fomula group - consume control infant milk fomula without NMN (commercial infant milk fomula) for 4 weeks after discharge from hospital

Outcome(s)

• Primary Outcome: Blood NAD concentration
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Juntendo University Hospital
• Source(s) of Monetary Support: Meiji Co., Ltd.