Determine How Consumption of Dairy Fat as Cheese Influences Inflammation-Phase 2
|ClinicalTrials.gov Identifier: NCT01803633|
Recruitment Status : Completed
First Posted : March 4, 2013
Last Update Posted : May 19, 2017
|Condition or disease||Intervention/treatment|
|Metabolic Syndrome Obesity||Other: Cheddar cheese Other: Vegan cheese|
Phase 2 is a randomized crossover study designed to determine how consumption of cheese compared with a non-dairy cheese substitute influences postprandial inflammation in participants who have 2 or more risk factors of metabolic syndrome or BMI ≥ 30.
Eligible participants will arrive to the Western Human Nutrition Research Center (WHNRC) at the University of California (UC) Davis campus on the morning of each test day after a 10-12-hr overnight fast. Upon arrival participants will fill out a questionnaire about their dietary and medication intakes and physical activity for the past 72 hours to ensure compliance. Compliant participants' weight and blood pressure will be measured and a fasting blood draw will be taken before participants consume their test meal (cheese or non-dairy cheese substitute). Participants will only consume this test meal and water freely for the duration of the test day. Blood will be drawn serially at 1, 3 and 6 hours postprandially. Participants will be tested on a second test day two weeks after the first test.
On the second test day, participants' body composition and bone mineral density will be measured by dual x-ray absorptiometry.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Effects of Dairy Fat on Postprandial Inflammation- Phase 2|
|Study Start Date :||September 2012|
|Primary Completion Date :||December 2016|
|Study Completion Date :||December 2016|
Cheese sandwich plus supplemental beverage will deliver 40% of each participants' energy expenditure and will be made up of 50% of energy as fat, 35% of energy as carbohydrate and 15% of energy as protein. The sandwich will contain medium cheddar cheese and whole wheat bread. The supplemental beverage will contain fruit sorbet, glucose polymer, protein powder, high oleic sunflower oil, high polyunsaturated fatty acids (PUFA) sunflower oil, and canola oil.
Other: Cheddar cheese
Tillamook medium cheddar cheese brand
Active Comparator: Vegan cheese
Non-dairy cheese alternative sandwich plus supplemental beverage will deliver 40% of each participants' energy expenditure and will be made up of 50% of energy as fat, 35% of energy as carbohydrate and 15% of energy as protein. The sandwich will contain vegan cheese and whole wheat bread. The supplemental beverage will contain fruit sorbet, glucose polymer, protein powder, cream of tartar, high oleic sunflower oil, high PUFA sunflower oil, and palm oil.
Other: Vegan cheese
Daiya brand vegan cheese
- Plasma inflammatory mediators [ Time Frame: 0, 1, 3, 6 hr postprandial ]Plasma cytokines will be measured using a multi-plex immunoassay and plasma oxylipins will be measured by mass spectroscopy.
- Plasma lipid profile [ Time Frame: 0, 1, 3, 6 hours postprandial ]Plasma lipids (triglycerides, total cholesterol, LDL-C, HDL-C) will be measured by enzymatic analysis by UC Davis Pathology Lab.
- Plasma bone markers [ Time Frame: 0, 1, 3, 6 hours postprandial ]Plasma N-terminal telopeptide (NTX), C-terminal telopeptide (CTX) and propeptide of type I collagen (P1NP) will be measured by multi-plex immunoassay.
- Urinary metabolites [ Time Frame: 0, 1, 3, 6 hours postprandial ]Urinary metabolites will be measured by nuclear magnetic resonance (NMR) spectroscopy.
- Plasma glucose [ Time Frame: 0, 1, 3, 6 hours postprandial ]Plasma glucose will be measured by enzymatic analysis by UC Davis Pathology Lab.
- Plasma lipoprotein size distribution [ Time Frame: 0, 1, 3, 6 hours postprandial ]Plasma lipoprotein size distribution and lipoprotein concentrations will be measured by LipoScience using NMR spectroscopy.
- Red blood cell functionality [ Time Frame: 0, 1, 3, 6 hours postprandial ]Red blood cells isolated from whole blood will be measured for sheer stress using an in-vitro microfluidic assay.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01803633
|United States, California|
|USDA Western Human Nutrition Research Center|
|Davis, California, United States, 95616|
|Principal Investigator:||Jennifer T. Smilowitz, PhD||University of California, Davis|
|Principal Investigator:||Angela M. Zivkovic, PhD||University of California, Davis|
|Principal Investigator:||Marta Van Loan, PhD||ARS USDA WHNRC|
|Principal Investigator:||J. Bruce German, PhD||UC Davis|
|Principal Investigator:||Bruce D. Hammock, PhD||UC Davis|