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NCT Number: NCT01811329

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

USDA Western Human Nutrition Research Center

Davis, California, 95616, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dairy fat

Dietary Supplement

Dairy fat + MFGM

Dietary Supplement

BPC50, a dairy fraction rich in milk fat globule membrane proteins and phospholipids manufactured by Fonterra, will make up 50% of the shake's total fat.

Palm fat

Dietary Supplement

Palm fat + MFGM

Dietary Supplement

BPC50, a dairy fraction rich in milk fat globule membrane proteins and phospholipids manufactured by Fonterra, will make up 50% of the shake's total fat.

Primary outcomes

  1. Plasma inflammatory mediators

    Time frame: Change from 0 hour up to 6 hours postprandial

    Plasma cytokines will be measured using a multi-plex immunoassay and plasma oxylipins will be measured by mass spectroscopy.

Secondary outcomes

  1. Plasma lipid profile

    Time frame: Change from 0 hour up to 6 hours postprandial

    Plasma lipids (triglycerides, total cholesterol, LDL-C, HDL-C) will be measured by enzymatic analysis by UC Davis Pathology Lab.

  2. Plasma bone markers

    Time frame: Change from 0 hour up to 6 hours postprandial

    Plasma N-terminal telopeptide (NTX), C-terminal telopeptide (CTX) and propeptide of type I collagen (P1NP) will be measured by multi-plex immunoassay.

  3. Urinary metabolites

    Time frame: Change from 0 hour up to 6 hours postprandial

    Urinary metabolites will be measured by nuclear magnetic resonance (NMR) spectroscopy.

  4. Plasma glucose

    Time frame: Change from 0 hour up to 6 hours postprandial

    Plasma glucose will be measured by enzymatic analysis by UC Davis Pathology Lab.

  5. Red blood cell functionality

    Time frame: Change from 0 hour up to 6 hours postprandial

    Red blood cells isolated from whole blood will be measured for sheer stress using an in-vitro microfluidic assay.

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • Dairy Research Institute

Registry information

Official study title

Effects of Dairy Fat on Postprandial Inflammation- Phase 1

Important dates

Study start
2013
Primary completion
2014
Study completion
2027
First posted
Mar 14, 2013
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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