Assessing the Presence of Casomorphins in Human Plasma After Dairy Ingestion - Full Text View

Sponsor:	The Washington Center for Clinical Research
Information provided by:	The Washington Center for Clinical Research
ClinicalTrials.gov Identifier:	NCT00360919

Purpose

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	Intervention	Phase
Food Habits	Behavioral: cheese ingestion	Phase 0

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Open Label, Uncontrolled, Crossover Assignment
Official Title:	Assessing the Presence of Casomorphins in Human Plasma After Dairy Ingestion

Further study details as provided by The Washington Center for Clinical Research:

Primary Outcome Measures:

casomorphin quantification [ Time Frame: Measurements will be collected on designated studys within 12-hour time frame ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	September 2006
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental 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.
B: Placebo Comparator 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.

Arms

Assigned Interventions

A: Experimental

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.

B: Placebo Comparator

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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00360919

Locations

United States, District of Columbia
Physicians Committee for Responsible Medicine
Washington, DC, District of Columbia, United States, 20016-4131

Sponsors and Collaborators

The Washington Center for Clinical Research

Investigators

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

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

Publications:

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

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

Brantl V, Teschemacher H, Blasig J, Henschen A, Lottspeich F. Opioid activities of beta-casomorphins. Life Sci. 1981 Apr 27;28(17):1903-9. No abstract available.

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.

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.

Responsible Party:	Physicians Committee for Responsible Medicine ( Neal Barnard, MD )
Study ID Numbers:	WCCR-01
Study First Received:	August 3, 2006
Last Updated:	May 11, 2009
ClinicalTrials.gov Identifier:	NCT00360919 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by The Washington Center for Clinical Research:

casomorphin
cheese
craving
casein
milk

Additional relevant MeSH terms:

Habits
Food Habits

ClinicalTrials.gov processed this record on February 08, 2010