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

Not Applicable

Active, not recruiting

• Conditions: Metabolic Syndrome; Obesity
• Interventions: Other: Cheddar cheese; Other: Vegan cheese

• 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

Arm && Interventions

Group	Intervention	Description
Cheese	Cheddar 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.
Vegan cheese	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.

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