Determine How Consumption of Dairy Fat Fractions Rich in Phospholipids and Proteins Influence Inflammation in the Fed State-Phase 1



Status:Completed
Conditions:Obesity Weight Loss, Endocrine
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 65
Updated:5/20/2017
Start Date:August 2013
End Date:December 2016

Use our guide to learn which trials are right for you!

Effects of Dairy Fat on Postprandial Inflammation- Phase 2

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.

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.

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.
We found this trial at
1
site
?
mi
from
Davis, CA
Click here to add this to my saved trials