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

Primary Purpose

Metabolic Syndrome, Obesity

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dairy fat
Dairy fat + MFGM
Palm fat
Palm fat + MFGM
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • USDA Western Human Nutrition Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

Palm fat

Palm fat + MFGM

Dairy fat

Dairy fat + MFGM

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Plasma inflammatory mediators
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
Plasma lipids (triglycerides, total cholesterol, LDL-C, HDL-C) will be measured by enzymatic analysis by UC Davis Pathology Lab.
Plasma bone markers
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
Urinary metabolites will be measured by nuclear magnetic resonance (NMR) spectroscopy.
Plasma glucose
Plasma glucose will be measured by enzymatic analysis by UC Davis Pathology Lab.
Red blood cell functionality
Red blood cells isolated from whole blood will be measured for sheer stress using an in-vitro microfluidic assay.

Full Information

First Posted
March 11, 2013
Last Updated
September 28, 2022
Sponsor
University of California, Davis
Collaborators
Dairy Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01811329
Brief Title
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 1, 2013 (Actual)
Primary Completion Date
June 17, 2014 (Actual)
Study Completion Date
January 29, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
Collaborators
Dairy Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Palm fat
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Palm fat + MFGM
Arm Type
Experimental
Arm Description
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.
Arm Title
Dairy fat
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Dairy fat + MFGM
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Dairy fat
Intervention Type
Dietary Supplement
Intervention Name(s)
Dairy fat + MFGM
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Palm fat
Intervention Type
Dietary Supplement
Intervention Name(s)
Palm fat + MFGM
Intervention Description
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 Outcome Measure Information:
Title
Plasma inflammatory mediators
Description
Plasma cytokines will be measured using a multi-plex immunoassay and plasma oxylipins will be measured by mass spectroscopy.
Time Frame
Change from 0 hour up to 6 hours postprandial
Secondary Outcome Measure Information:
Title
Plasma lipid profile
Description
Plasma lipids (triglycerides, total cholesterol, LDL-C, HDL-C) will be measured by enzymatic analysis by UC Davis Pathology Lab.
Time Frame
Change from 0 hour up to 6 hours postprandial
Title
Plasma bone markers
Description
Plasma N-terminal telopeptide (NTX), C-terminal telopeptide (CTX) and propeptide of type I collagen (P1NP) will be measured by multi-plex immunoassay.
Time Frame
Change from 0 hour up to 6 hours postprandial
Title
Urinary metabolites
Description
Urinary metabolites will be measured by nuclear magnetic resonance (NMR) spectroscopy.
Time Frame
Change from 0 hour up to 6 hours postprandial
Title
Plasma glucose
Description
Plasma glucose will be measured by enzymatic analysis by UC Davis Pathology Lab.
Time Frame
Change from 0 hour up to 6 hours postprandial
Title
Red blood cell functionality
Description
Red blood cells isolated from whole blood will be measured for sheer stress using an in-vitro microfluidic assay.
Time Frame
Change from 0 hour up to 6 hours postprandial

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer T Smilowitz, PhD
Organizational Affiliation
UC Davis
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Angela M. Zivkovic, PhD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marta Van Loan, PhD
Organizational Affiliation
ARS USDA WHNRC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
J. Bruce German, PhD
Organizational Affiliation
UC Davis
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bruce Hammock, PhD
Organizational Affiliation
UC Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
USDA Western Human Nutrition Research Center
City
Davis
State/Province
California
ZIP/Postal Code
95616
Country
United States

12. IPD Sharing Statement

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21270379
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Links:
URL
http://ffhi.ucdavis.edu/human-studies/dairy-fat-inflammation
Description
More information about the research is available on the UC Davis Foods for Health Institute's website

Learn more about this trial

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

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