Assessing the Presence of Casomorphins in Human Plasma After Dairy Ingestion

Food Habits Clinical Trial

Official title:

Assessing the Presence of Casomorphins in Human Plasma After Dairy Ingestion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00360919
• Other study ID #: WCCR-01
• Status: Completed
• Phase: Phase 0
• First received: August 3, 2006
• Last updated: August 6, 2012
• Start date: September 2006
• Est. completion date: December 2010

Study information

• Verified date: August 2012
• Source: Physicians Committee for Responsible Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Food Habits

Intervention

Behavioral:
• cheese ingestion
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.

Locations

Country	Name	City	State
United States	Physicians Committee for Responsible Medicine	Washington, DC	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Physicians Committee for Responsible Medicine

Country where clinical trial is conducted

United States, 

References & Publications (5)

Brantl V, Teschemacher H, Bläsig J, Henschen A, Lottspeich F. Opioid activities of beta-casomorphins. Life Sci. 1981 Apr 27;28(17):1903-9. — View Citation

Drewnowski A, Krahn DD, Demitrack MA, Nairn K, Gosnell BA. Taste responses and preferences for sweet high-fat foods: evidence for opioid involvement. Physiol Behav. 1992 Feb;51(2):371-9. — View Citation

Meisel H, FitzGerald RJ. Opioid peptides encrypted in intact milk protein sequences. Br J Nutr. 2000 Nov;84 Suppl 1:S27-31. Review. — View Citation

Shah NP. Effects of milk-derived bioactives: an overview. Br J Nutr. 2000 Nov;84 Suppl 1:S3-10. Review. — View Citation

Svedberg J, de Haas J, Leimenstoll G, Paul F, Teschemacher H. Demonstration of beta-casomorphin immunoreactive materials in in vitro digests of bovine milk and in small intestine contents after bovine milk ingestion in adult humans. Peptides. 1985 Sep-Oct;6(5):825-30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	casomorphin quantification		Measurements will be collected on designated studys within 12-hour time frame	No

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