Status:
ACTIVE_NOT_RECRUITING
Determine How Consumption of Dairy Fat Fractions Rich in Phospholipids and Proteins Influence Inflammation in the Fed State-Phase 1
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 1 of this study involves determining how consumption of dairy fat fractions rich in milk fat globule membrane influences postprandial inflammation in participants with metabolic syndrome or obes...
Detailed Description
Phase 1 is a randomized crossover study designed to determine how inclusion of dairy fractions rich in milk fat globule membrane (MFGM) to shakes rich in dairy or palm fat influence postprandial infla...
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 :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 29 2027
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT01811329
Start Date
August 1 2013
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