NCT06598124

Effects of Low Lactose Milk Containing GOS on Digestive Response in Healthy Chinese Adults

Assessing the Effects of Low Lactose Milk Containing GOS (Galactooligosaccharides) on Digestive Response in Healthy Chinese Adults

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

We are aiming to assess the effects of low lactose milk containing galactooligosaccharides (GOS) on digestive response in healthy Chinese adults in comparison with a matching milk containing lactose.

Detailed description

This is planned to be single-center, double-blind, randomized, 2x2 cross-over study. 24 healthy participants of Chinese ethnicity are planned to be enrolled. Participants will be invited to three visit days at the research site: a screening visit and two test days, 3 to 28 days apart. During the test days, participants will be requested, after overnight fasting, to consume either the investigational product (IP), a skimmed milk powder with low lactose content and GOS, or the comparator product (CP) a matching skimmed milk powder, both reconstituted in water. Participants will then undergo a series of tests to compare the effects of these two drinks on gastrointestinal fluid retention and motility as well as on gut comfort.

Conditions

• Healthy

Interventions

Type	Name	Description
OTHER	Investigational Product (IP)	1 single dose of IP consisting in 400 mL of milk with low lactose content and GOS.
OTHER	Comparator Product (CP)	1 single dose of CP consisting in 400 mL of milk with lactose

Timeline

• Start date: 2024-08-20
• Primary completion: 2025-04-21
• Completion: 2025-06-30
• First posted: 2024-09-19
• Last updated: 2025-11-24

Locations

1 site across 1 country: United Kingdom