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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01811329
First Posted: March 14, 2013
Last Update Posted: May 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Dairy Research Institute
Information provided by (Responsible Party):
University of California, Davis
  Purpose
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.

Condition Intervention
Metabolic Syndrome Obesity Dietary Supplement: Dairy fat Dietary Supplement: Dairy fat + MFGM Dietary Supplement: Palm fat Dietary Supplement: Palm fat + MFGM

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effects of Dairy Fat on Postprandial Inflammation- Phase 2

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

  • 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.

  • Urinary metabolites [ Time Frame: Change from 0 hour up to 6 hours postprandial ]
    Urinary metabolites will be measured by nuclear magnetic resonance (NMR) spectroscopy.

  • 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.

  • 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.


Enrollment: 38
Study Start Date: August 2013
Study Completion Date: December 2016
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Palm fat
The amount of calories in the shake will be equivalent to 30% of each participant's calculated energy expenditure. The macronutrient composition of the shake as a percent of energy will be: 45% fat, 40% carbohydrate and 15% protein. The shake will contain palm fat, frozen fruit, glucose polymer, and protein powder.
Dietary Supplement: Palm fat
Experimental: Palm fat + MFGM
The amount of calories in the shake will be equivalent to 30% of each participant's calculated energy expenditure. The macronutrient composition of the shake as a percent of energy will be: 45% fat, 40% carbohydrate and 15% protein. The shake will contain palm fat, frozen fruit, glucose polymer, and BPC50, a dairy fraction rich in milk fat globule membrane proteins and phospholipids. Fifty percent of the shake's fat will be derived from BPC50.
Dietary Supplement: Palm fat + MFGM
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.
Active Comparator: Dairy fat
The amount of calories in the shake will be equivalent to 30% of each participant's calculated energy expenditure. The macronutrient composition of the shake as a percent of energy will be: 45% fat, 40% carbohydrate and 15% protein. The shake will contain whipping cream, frozen fruit, glucose polymer, and protein powder.
Dietary Supplement: Dairy fat
Experimental: Dairy fat + MFGM
The amount of calories in the shake will be equivalent to 30% of each participant's calculated energy expenditure. The macronutrient composition of the shake as a percent of energy will be: 45% fat, 40% carbohydrate and 15% protein. The shake will contain whipping cream, frozen fruit, glucose polymer, and BPC50, a dairy fraction rich in milk fat globule membrane proteins and phospholipids. Fifty percent of the shake's fat will be derived from BPC50.
Dietary Supplement: Dairy fat + MFGM
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.

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01811329


Locations
United States, California
USDA Western Human Nutrition Research Center
Davis, California, United States, 95616
Sponsors and Collaborators
University of California, Davis
Dairy Research Institute
Investigators
Principal Investigator: Jennifer T Smilowitz, PhD UC Davis
Principal Investigator: Angela M. Zivkovic, PhD University of California, Davis
Principal Investigator: Marta Van Loan, PhD ARS USDA WHNRC
Principal Investigator: J. Bruce German, PhD UC Davis
Principal Investigator: Bruce Hammock, PhD UC Davis
  More Information

Additional Information:
Publications:

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT01811329     History of Changes
Other Study ID Numbers: 264297-1
264297-1 ( Other Identifier: UC Davis IRB )
First Submitted: March 11, 2013
First Posted: March 14, 2013
Last Update Posted: May 19, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Inflammation
Metabolic Syndrome X
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Milk fat globule
Anti-Infective Agents