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

November 27, 2023 updated by: University of California, Davis

Effects of Dairy Fat on Postprandial Inflammation- 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Davis, California, United States, 95616
        • USDA Western Human Nutrition Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from 0 hour up to 6 hours postprandial

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2013

Primary Completion (Actual)

June 17, 2014

Study Completion (Estimated)

January 29, 2027

Study Registration Dates

First Submitted

March 11, 2013

First Submitted That Met QC Criteria

March 12, 2013

First Posted (Estimated)

March 14, 2013

Study Record Updates

Last Update Posted (Actual)

November 28, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 264297-1 (Other Identifier: UC Davis IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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