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Determine How Consumption of Dairy Fat as Cheese Influences Inflammation-Phase 2

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Dairy Research Institute
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT01803633
First received: February 28, 2013
Last updated: August 18, 2014
Last verified: August 2014
  Purpose

Phase 2 of this study involves determining how consumption of cheese compared with a non-dairy cheese substitute influences inflammation over a six hour period.


Condition Intervention
Metabolic Syndrome
Obesity
Other: Cheddar cheese
Other: Vegan cheese

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effects of Dairy Fat on Postprandial Inflammation- Phase 2

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Plasma inflammatory mediators [ Time Frame: 0, 1, 3, 6 hr postprandial ] [ Designated as safety issue: No ]
    Plasma cytokines will be measured using a multi-plex immunoassay and plasma oxylipins will be measured by mass spectroscopy.


Secondary Outcome Measures:
  • Plasma lipid profile [ Time Frame: 0, 1, 3, 6 hours postprandial ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Urinary metabolites will be measured by nuclear magnetic resonance (NMR) spectroscopy.

  • Plasma glucose [ Time Frame: 0, 1, 3, 6 hours postprandial ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Red blood cells isolated from whole blood will be measured for sheer stress using an in-vitro microfluidic assay.


Estimated Enrollment: 20
Study Start Date: September 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cheese
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18-65 years
  • Two or more components of metabolic syndrome:

Central obesity (waist circumference greater than 40 inches for men and 35 inches for women); fasting blood triglycerides greater than or equal to 150 mg/dL; plasma HDL cholesterol (Less than 40 mg/dL for men and less than 50 mg/dL for women); blood pressure greater than or equal to 130/85 mmHg; fasting glucose greater than or equal to 100 mg/dL

or

- BMI equal to or greater than 30

Exclusion Criteria:

Metabolic Disorders:

  • BMI > 40
  • Body weight more than 400 lbs.
  • Any immune related diseases such as autoimmune disease, rheumatoid arthritis, asthma,
  • Gastrointestinal disorders including Crohn's Disease, colitis, diverticulitis, irritable bowel disease, celiac, malabsorption syndrome
  • Cancer
  • Known presence of significant metabolic disease which could impact the results of the study (i.e. hepatic, renal disease)
  • Type II diabetes
  • Use of over-the-counter anti-obesity agents (e.g. containing phenylpropanolamine, ephedrine, and/or caffeine) within the last 12 weeks
  • Use of corticoid steroids within the last 12 weeks
  • Daily use of anti-inflammatory pain medication
  • Self report of eating disorder
  • Poor vein assessment determined by WHNRC's phlebotomist

Dietary/supplements:

  • Known allergy or intolerance to study food (lactose intolerance, dairy, wheat allergies)
  • Vegetarian (defined as abstinence from consumption of eggs, dairy, poultry, beef and pork)
  • More than 1 serving of fish per week
  • More than 14 grams of fiber per 1000 kcal per day
  • Less than 16:1 of total dietary omega 6: Omega 3 ratio
  • More than 1% of daily energy as trans fats
  • Initiation of anti-inflammatory supplemental fish, krill, flax, borage and primrose seed oils within the last 12 weeks
  • Dietary supplements consisting of concentrated soy isoflavones, resveratrol, other polyphenols identified as modulators of inflammation Medications
  • Initiation of statin therapy within the last 12 weeks Lifestyle
  • More than 10% weight loss or gain during the past 6 months
  • Recent initiation (past 4 weeks) of exercise program
  • Plan to become pregnant in the next 6 months
  • Pregnancy or lactation
  • Recent initiation or cessation of hormonal birth control or change in hormonal birth control regimen within the last 12 weeks
  • Use of tobacco products
  • More than 2 standard alcoholic drinks per day.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01803633

Locations
United States, California
USDA Western Human Nutrition Research Center
Davis, California, United States, 95616
Sponsors and Collaborators
University of California, Davis
Dairy Research Institute
Investigators
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
  More Information

Additional Information:
Publications:
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT01803633     History of Changes
Other Study ID Numbers: 264297-2
Study First Received: February 28, 2013
Last Updated: August 18, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Inflammation
Metabolic Syndrome X
Glucose Metabolism Disorders
Hyperinsulinism
Insulin Resistance
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 27, 2014