Status:
ACTIVE_NOT_RECRUITING
Determine How Consumption of Dairy Fat as Cheese Influences Inflammation-Phase 2
Lead Sponsor:
University of California, Davis
Collaborating Sponsors:
Dairy Research Institute
Conditions:
Metabolic Syndrome
Obesity
Eligibility:
All Genders
18-65 years
Phase:
NA
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 m...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 29 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01803633
Start Date
September 1 2012
End Date
January 29 2027
Last Update
December 15 2025
Active Locations (1)
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1
USDA Western Human Nutrition Research Center
Davis, California, United States, 95616