Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06598124
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-15
Brief Title:
Effects of Low Lactose Milk Containing GOS on Digestive Response in Healthy Chinese Adults
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Assessing the Effects of Low Lactose Milk Containing GOS Galactooligosaccharides on Digestive Response in Healthy Chinese Adults
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MilkRI
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None