Assessing the Presence of Casomorphins in Human Plasma After Dairy Ingestion

Study Overview
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Brief Summary
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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
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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.

Official Title
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Assessing the Presence of Casomorphins in Human Plasma After Dairy Ingestion

Conditions
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Food Habits

Intervention / Treatment
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* Behavioral: cheese ingestion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age greater than 18 years Male or female Either self-described as having a strong liking for cheese, or have been following a vegan diet for a least the previous six months. Exclusion Criteria: Unstable medical status Physical condition affecting eating behavior, digestion, or intestinal absorption Dairy allergy or lactose intolerance Pregnancy History of severe mental illness Smoking during the past six months Alcohol consumption of more than two drinks per day History of substance abuse or dependency followed by any current use Inordinate fear of blood draws

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Cheese | Behavioral: cheese ingestion<br>* On 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.<br>|
| Placebo Comparator: B<br>Fruits and vegetables | Behavioral: cheese ingestion<br>* On 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| casomorphin quantification |  | Measurements will be collected on designated studys within 12-hour time frame | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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casomorphin, cheese, craving, casein, milk