Clinical trial NCT01811329: Determine How Consumption of Dairy Fat Fractions Rich in Phospholipids and Proteins Influence Inflammation in the Fed State-Phase 1
Official title: Effects of Dairy Fat on Postprandial Inflammation- Phase 1
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Metabolic Syndrome
Obesity
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Dairy Research Institute
First posted: 2013-03-14
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 obesity during a high dietary fat challenge in a six-hour period.

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 inflammation. Participants who have 2 or more risk factors of metabolic syndrome or BMI ≥ 30 will consume four shakes on separate days. The four shakes are: high dairy fat, high dairy fat + MFGM, high palm fat, high palm fat + MFGM.

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. 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 the additional three arms on three different spaced apart by two weeks.

On the third or fourth test day, participants' body composition and bone mineral density will be measured by dual x-ray absorptiometry.

Eligibility criteria: 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.

Primary outcomes:
measure: Plasma inflammatory mediators
timeFrame: Change from 0 hour up to 6 hours postprandial
Secondary outcomes:
measure: Plasma lipid profile
timeFrame: Change from 0 hour up to 6 hours postprandial
measure: Plasma bone markers
timeFrame: Change from 0 hour up to 6 hours postprandial
measure: Urinary metabolites
timeFrame: Change from 0 hour up to 6 hours postprandial
measure: Plasma glucose
timeFrame: Change from 0 hour up to 6 hours postprandial
measure: Red blood cell functionality
timeFrame: Change from 0 hour up to 6 hours postprandial
Other outcomes:
Locations:
city: Davis
country: United States
facility: USDA Western Human Nutrition Research Center
state: California
Study officials:
affiliation: UC Davis
name: Jennifer T Smilowitz, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Davis
name: Angela M. Zivkovic, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: ARS USDA WHNRC
name: Marta Van Loan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UC Davis
name: J. Bruce German, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UC Davis
name: Bruce Hammock, PhD
role: PRINCIPAL_INVESTIGATOR
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