Assessing the Presence of Casomorphins in Human Plasma After Dairy Ingestion
NCT ID: NCT00360919
Last Updated: 2012-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
28 participants
INTERVENTIONAL
2006-09-30
2010-12-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
NONE
Study Groups
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A
Cheese
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
Fruits and vegetables
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Physicians Committee for Responsible Medicine
OTHER
Responsible Party
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Principal Investigators
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Neal Barnard, MD
Role: PRINCIPAL_INVESTIGATOR
Physicians Committee for Responsible Medicine
Hope R Ferdowsian, MD, MPH
Role: STUDY_DIRECTOR
Washington Center for Clinical Research
Locations
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Physicians Committee for Responsible Medicine
Washington D.C., District of Columbia, United States
Countries
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References
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Shah NP. Effects of milk-derived bioactives: an overview. Br J Nutr. 2000 Nov;84 Suppl 1:S3-10. doi: 10.1017/s000711450000218x.
Meisel H, FitzGerald RJ. Opioid peptides encrypted in intact milk protein sequences. Br J Nutr. 2000 Nov;84 Suppl 1:S27-31. doi: 10.1017/s000711450000221x.
Brantl V, Teschemacher H, Blasig J, Henschen A, Lottspeich F. Opioid activities of beta-casomorphins. Life Sci. 1981 Apr 27;28(17):1903-9. doi: 10.1016/0024-3205(81)90297-6. 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. doi: 10.1016/0196-9781(85)90308-0.
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. doi: 10.1016/0031-9384(92)90155-u.
Related Links
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Related Info
Other Identifiers
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WCCR-01
Identifier Type: -
Identifier Source: org_study_id