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

Not Applicable

Active, not recruiting

• Conditions: Metabolic Syndrome; Obesity

• Registration Number: NCT01803633
• Lead Sponsor: University of California, Davis

Brief Summary

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.

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.

Study Timeline

• Study Start: 2012-09-01
• Study First Submitted: 2013-02-28
• Study First Submitted QC: 2013-03-01
• Study First Posted: 2013-03-04
• Primary Completion: 2013-08-13
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-05
• Study Completion: 2027-01-29

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Plasma inflammatory mediators	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.

Secondary Outcome Measures

Name	Time	Method
Plasma lipid profile	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.
Urinary metabolites	0, 1, 3, 6 hours postprandial	Urinary metabolites will be measured by nuclear magnetic resonance (NMR) spectroscopy.
Plasma glucose	0, 1, 3, 6 hours postprandial	Plasma glucose will be measured by enzymatic analysis by UC Davis Pathology Lab.
Red blood cell functionality	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.
Plasma bone markers	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.
Plasma lipoprotein size distribution	0, 1, 3, 6 hours postprandial	Plasma lipoprotein size distribution and lipoprotein concentrations will be measured by LipoScience using NMR spectroscopy.

Trial Locations

Locations (1)

USDA Western Human Nutrition Research Center; 🇺🇸 Davis, California, United States