Double Crossover Casein Type Tolerance Trial
A Randomized Controlled Crossover Trial to Assess Tolerance, Gastrointestinal Distress & Preference for Milks Varying in Casein Types & Lactose Content
2 other identifiers
interventional
48
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 2, 2024
CompletedFirst Posted
Study publicly available on registry
March 18, 2024
CompletedStudy Start
First participant enrolled
April 20, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 26, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2024
CompletedApril 4, 2025
April 1, 2025
3 months
March 2, 2024
April 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Gastrointestinal Distress Scores
Changes in gastrointestinal distress measured via visual analog scales that range from 0 (no symptoms) to 100 cm (severe symptoms). Lower values are optimal.
24 hours after each sample challenge
Secondary Outcomes (6)
Breath Hydrogen (ppm)
Three hours after each sample challenge
Breath Methane (ppm)
Three hours after each sample challenge
Blood Glucose (mg/dl)
Two hours after each sample challenge
Stool microbiome composition
One week after each sample challenge
Stool Beta-casomorphin-7 (BCM-7)
One week after each sample challenge
- +1 more secondary outcomes
Study Arms (3)
Conventional lactose-free milk first
EXPERIMENTALParticipants will consume conventional lactose-free milk first, then each of the other milk types in random order
Non-conventional (A2) lactose-free milk first
EXPERIMENTALParticipants will consume non-conventional (A2) lactose-free milk first, then each of the other milk types in random order
Non-conventional (A2) milk first
EXPERIMENTALParticipants will consume non-conventional (A2) milk first, then each of the other milk types in random order
Interventions
Participants will receive conventional lactose-free cow's milk as follows: On Day 1, participants will receive 50mg casein/kg/bw (\~125ml milk). On Day 3, participants will receive 100mg casein/kg/bw (\~250ml milk). On Day 5, participants will received 200mg casein/kg/bw (\~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.
Participants will receive nonconventional (A2) cow's milk as follows: On Day 1, participants will receive 50mg casein/kg/bw (\~125ml milk). On Day 3, participants will receive 100mg casein/kg/bw (\~250ml milk). On Day 5, participants will received 200mg casein/kg/bw (\~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.
Participants will receive nonconventional (A2) lactose-free cow's milk as follows: On Day 1, participants will receive 50mg casein/kg/bw (\~125ml milk). On Day 3, participants will receive 100mg casein/kg/bw (\~250ml milk). On Day 5, participants will received 200mg casein/kg/bw (\~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.
Eligibility Criteria
You may qualify if:
- Adults age 18+
- Currently avoid liquid milk
- Can read and speak English
You may not qualify if:
- Diagnosis of milk protein allergy
- Diagnosis of Crohn's Disease, Ulcerative Colitis, Celiac Disease, or Peptic Ulcer Disease or Gastroparesis
- Using antibiotic or antiviral medications within 30 days prior to study start
- Undergoing chemotherapy, or using any investigational drugs within 30 days prior to study start
- Pregnant or lactating
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Auburn University
Auburn, Alabama, 36849, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew D Frugé, PhD
Auburn University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
March 2, 2024
First Posted
March 18, 2024
Study Start
April 20, 2024
Primary Completion
July 26, 2024
Study Completion
July 31, 2024
Last Updated
April 4, 2025
Record last verified: 2025-04