Double Crossover Casein Type Tolerance Trial

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.

Conditions

• Dairy Intolerance
• Healthy Adults

Interventions

OTHER

Conventional lactose-free cow's milk

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.

OTHER

Nonconventional (A2) cow's milk

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.

OTHER

Nonconventional (A2) lactose-free cow's milk

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.

Sponsors & Collaborators

• Auburn University

  lead OTHER

Principal Investigators

• Andrew D Frugé, PhD · Auburn University

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-04-20

Primary Completion

2024-07-26

Completion

2024-07-31

Countries

• United States

Study Locations