Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06315517
Status:
RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-03-02
Brief Title:
Double Crossover Casein Type Tolerance Trial
Sponsor:
Auburn University
Organization:
Auburn University
Study Overview
Official Title:
A Randomized Controlled Crossover Trial to Assess Tolerance Gastrointestinal Distress Preference for Milks Varying in Casein Types Lactose Content
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators will recruit 45 fluid milk avoiding adults to participate in a five-week double-blind double-crossover study in which the physiological responses to increasing doses of lactose-free A1-rich milk A2 milk and lactose-free A2 milk will be explored
Detailed Description:
Dairy provides essential nutrients and dairy products and are among the best quality and bioavailable protein sources available to humans Milk protein allergy is extremely rare outside of childhood and lactose intolerance is highly variable among ethnicities Nonetheless many adults avoid fluid milk and dairy products unnecessarily Recent studies suggest that dairy intolerant individuals are having gastrointestinal reactions specifically to the bioactive metabolites specifically beta-casomorphin-7BCM-7 of casein protein subtype A1 and consuming milk void of A1 and rich in A2 casein alleviates symptoms
The investigators will recruit 45 fluid milk avoiding adults to participate in a five-week double-blind double-crossover study in which physiological responses to increasing doses of lactose-free A1-rich milk A2 milk and lactose-free A2 milk will be explored Enrollment assessments will include a comprehensive metabolic panel diet history and medical history questionnaires Stool samples will be collected at the beginning and end of each of the 3 test phases 6 total samples per participant Each test phase will last 6 days long during which participants will receive increased doses of casein every 2 days
On Day 1 participants will receive 50mg caseinkgbw 125ml milk On Day 3 participants will receive 100mg caseinkgbw 250ml milk On Day 5 participants will received 200mg caseinkgbw 500ml milk During test phases breath hydrogen and methane will be measured every thirty minutes for three hours and blood glucose will be measured every thirty minutes for two hours Gastrointestinal symptoms will be assessed with visual analog scales for the following 24 hours There will be a 7-10 day wash out period in between test phases
The investigators will recruit 45 fluid milk avoiding adults to participate in a five-week double-blind double-crossover study in which physiological responses to increasing doses of lactose-free A1-rich milk A2 milk and lactose-free A2 milk will be explored Enrollment assessments will include a comprehensive metabolic panel diet history and medical history questionnaires Stool samples will be collected at the beginning and end of each of the 3 test phases 6 total samples per participant Each test phase will last 6 days long during which participants will receive increased doses of casein every 2 days
On Day 1 participants will receive 50mg caseinkgbw 125ml milk On Day 3 participants will receive 100mg caseinkgbw 250ml milk On Day 5 participants will received 200mg caseinkgbw 500ml milk During test phases breath hydrogen and methane will be measured every thirty minutes for three hours and blood glucose will be measured every thirty minutes for two hours Gastrointestinal symptoms will be assessed with visual analog scales for the following 24 hours There will be a 7-10 day wash out period in between test phases
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1792-23P | OTHER_GRANT | The Dairy Alliance | None |