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

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-01

Study Completion Date

2027-01-29

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Metabolic Syndrome Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Cheddar cheese

Intervention Type OTHER

Tillamook medium cheddar cheese brand

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.

Group Type ACTIVE_COMPARATOR

Vegan cheese

Intervention Type OTHER

Daiya brand vegan cheese

Interventions

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Cheddar cheese

Tillamook medium cheddar cheese brand

Intervention Type OTHER

Vegan cheese

Daiya brand vegan cheese

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes