Assessing the Presence of Casomorphins in Human Plasma After Dairy Ingestion

Sponsor
Physicians Committee for Responsible Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT00360919
Collaborator
(none)
28
1
2
51
0.5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: cheese ingestion
Early Phase 1

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
28 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Assessing the Presence of Casomorphins in Human Plasma After Dairy Ingestion
Study Start Date :
Sep 1, 2006
Actual Primary Completion Date :
Dec 1, 2010
Actual Study Completion Date :
Dec 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: A

Cheese

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.

Placebo Comparator: B

Fruits and vegetables

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.

Outcome Measures

Primary Outcome Measures

  1. casomorphin quantification [Measurements will be collected on designated studys within 12-hour time frame]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Physicians Committee for Responsible Medicine Washington, DC District of Columbia United States 20016-4131

Sponsors and Collaborators

  • Physicians Committee for Responsible Medicine

Investigators

  • Principal Investigator: Neal Barnard, MD, Physicians Committee for Responsible Medicine
  • Study Director: Hope R Ferdowsian, MD, MPH, Washington Center for Clinical Research

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Physicians Committee for Responsible Medicine
ClinicalTrials.gov Identifier:
NCT00360919
Other Study ID Numbers:
  • WCCR-01
First Posted:
Aug 7, 2006
Last Update Posted:
Aug 7, 2012
Last Verified:
Aug 1, 2012
Keywords provided by Physicians Committee for Responsible Medicine

Study Results

No Results Posted as of Aug 7, 2012