Clinical Trials Directory

Trials / Completed

CompletedNCT00360919

Assessing the Presence of Casomorphins in Human Plasma After Dairy Ingestion

Status
Completed
Phase
EARLY_Phase 1
Study type
Interventional
Enrollment
28 (actual)
Sponsor
Physicians Committee for Responsible Medicine · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

This purpose of this study is to perform a pilot investigation to determine if opioid peptides such as casomorphin can be detected in human plasma after cheese ingestion.

Detailed description

Cheese is one of the most commonly craved foods, suggesting the possibility of opiate activity, as has been demonstrated with other craved foods, particularly chocolate. Like other dairy products, cheese contains casein, which is the major protein in cow's milk. This is unlike human milk, in which the primary protein is whey. Casein includes αs1-, αs2-, β- , and κ-casein, with αs1 and β forms predominating. Human and bovine casein molecules are cleaved during digestion to release opioid peptides that are believed to have biological properties relevant to infant physiology and behavior. Specifically, β-casein is cleaved to form β-casomorphins. Like other opiate agonists, β-casomorphins prolong gastrointestinal transit time and have an antidiarrheal effect. Casomorphin receptor binding has been demonstrated in opiate receptor assays and bioassays. Duodenal aspirates from human volunteers given cow's milk have demonstrated the presence of several casomorphins, particularly β-casomorphin-7. Few studies have assessed the presence or action of casomorphins in humans. The ability of casein-derived opioid peptides to pass into the bloodstream is not well characterized, and is the subject of the present study.

Conditions

Interventions

TypeNameDescription
BEHAVIORALcheese ingestionOn study day 1, approximately half of the participants will consume a breakfast of fruits and vegetables, whereas the other half of participants will consume a meal consisting of 9 oz. of cheese. Blood samples will be collected from participants immediately prior to consumption of the meals, and then again at regular intervals for up to 8 hours following the meals. At least 3 days later, participants will return for study Day 2. The participants will receive the second meal. Blood samples will then be collected immediately prior to consumption of the test meal and for up to 8 hours after the meal.

Timeline

Start date
2006-09-01
Primary completion
2010-12-01
Completion
2010-12-01
First posted
2006-08-07
Last updated
2012-08-07

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00360919. Inclusion in this directory is not an endorsement.