Comparing Inflammation, Lactose Intolerance and Lactose Maldigestion in Lactose Maldigesters on Consumption of Commercial Milk Containing A1 and A2 Beta-Casein and A2 Milk Containing Only A2 Beta-Casein for Two Weeks

Status: Unknown
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Cow's milk contains two types of β-casein: A1 and A2. It is evident from human clinical trials that milk with A1 protein produces more hydrogen and symptoms of lactose intolerance. A pro-inflammatory μ-opioid peptide BCM-7 is released from A1 but not from A2. Milk containing A1 β-casein produced more inflammatory markers than A2 β-casein. This is a double-blinded, randomized, controlled trial conducted to determine if there are changes in inflammatory markers following two weeks of milk feeding, due to milk containing A1 and A2 beta-casein as compared to milk containing only A2 beta-casein.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:

• Ability/desire to provide informed consent Aged 18 to 65 years of age inclusive at screening Current or recent history of intolerance to or avoidance of dairy of at least one month duration (by self-report and self-reported symptoms).

⁃ Agrees to refrain from all other treatments and products used for dairy intolerance (e.g., Lactaid® Dietary Supplements) during study involvement Willing to return for all study visits and complete all study related procedures Able to understand and provide written informed consent in English

Locations
United States
Indiana
Purdue University
RECRUITING
West Lafayette
Contact Information
Primary
Dennis Savaiano, PhD
savaiano@purdue.edu
765-494-8228
Backup
Tracy Eaton, MSW
tkeaton@purdue.edu
Time Frame
Start Date: 2021-12-02
Completion Date: 2025-12-06
Participants
Target number of participants: 35
Treatments
Experimental: Old World milk
Old World milk containing only a2 beta-casein vs. New World milk that includes both a1 and a2 beta-casein
Experimental: New World milk
Old World milk containing only a2 beta-casein vs. New World milk that includes both a1 and a2 beta-casein
Related Therapeutic Areas
Sponsors
Leads: Purdue University

This content was sourced from clinicaltrials.gov