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

NCT01811329 | Active Not Recruiting

• 1 other identifier: 264297-1
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome; Obesity

Outcome Measures

Primary Outcomes (1)

• Plasma inflammatory mediators

  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 Outcomes (5)

• Plasma lipid profile

  Change from 0 hour up to 6 hours postprandial

• Plasma bone markers

  Change from 0 hour up to 6 hours postprandial

• Urinary metabolites

  Change from 0 hour up to 6 hours postprandial

• Plasma glucose

  Change from 0 hour up to 6 hours postprandial

• Red blood cell functionality

  Change from 0 hour up to 6 hours postprandial

Study Arms (4)

Palm fat

ACTIVE COMPARATOR

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

Palm fat + MFGM

EXPERIMENTAL

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

Dairy fat

ACTIVE COMPARATOR

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

Dairy fat + MFGM

EXPERIMENTAL

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

Interventions

Dairy fat DIETARY_SUPPLEMENT

Dairy fat

Palm fat DIETARY_SUPPLEMENT

Palm fat

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.

Dairy fat + MFGM

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.

Palm fat + MFGM

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• \- BMI equal to or greater than 30

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, Davis: lead
• Dairy Research Institute: collaborator

Study Sites (1)

USDA Western Human Nutrition Research Center

Davis, California, 95616, United States

Location

Related Publications (11)

• Astrup A, Dyerberg J, Elwood P, Hermansen K, Hu FB, Jakobsen MU, Kok FJ, Krauss RM, Lecerf JM, LeGrand P, Nestel P, Riserus U, Sanders T, Sinclair A, Stender S, Tholstrup T, Willett WC. The role of reducing intakes of saturated fat in the prevention of cardiovascular disease: where does the evidence stand in 2010? Am J Clin Nutr. 2011 Apr;93(4):684-8. doi: 10.3945/ajcn.110.004622. Epub 2011 Jan 26.

  PMID: 21270379 BACKGROUND

• Kratz M, Baars T, Guyenet S. The relationship between high-fat dairy consumption and obesity, cardiovascular, and metabolic disease. Eur J Nutr. 2013 Feb;52(1):1-24. doi: 10.1007/s00394-012-0418-1. Epub 2012 Jul 19.

  PMID: 22810464 BACKGROUND

• Snow DR, Ward RE, Olsen A, Jimenez-Flores R, Hintze KJ. Membrane-rich milk fat diet provides protection against gastrointestinal leakiness in mice treated with lipopolysaccharide. J Dairy Sci. 2011 May;94(5):2201-12. doi: 10.3168/jds.2010-3886.

  PMID: 21524510 BACKGROUND

• Dalbeth N, Gracey E, Pool B, Callon K, McQueen FM, Cornish J, MacGibbon A, Palmano K. Identification of dairy fractions with anti-inflammatory properties in models of acute gout. Ann Rheum Dis. 2010 Apr;69(4):766-9. doi: 10.1136/ard.2009.113290. Epub 2009 Aug 26.

  PMID: 19713204 BACKGROUND

• Dalbeth N, Palmano K. Effects of dairy intake on hyperuricemia and gout. Curr Rheumatol Rep. 2011 Apr;13(2):132-7. doi: 10.1007/s11926-010-0160-8.

  PMID: 21188562 BACKGROUND

• El Alwani M, Wu BX, Obeid LM, Hannun YA. Bioactive sphingolipids in the modulation of the inflammatory response. Pharmacol Ther. 2006 Oct;112(1):171-83. doi: 10.1016/j.pharmthera.2006.04.004. Epub 2006 Jun 8.

  PMID: 16759708 BACKGROUND

• Dial EJ, Zayat M, Lopez-Storey M, Tran D, Lichtenberger L. Oral phosphatidylcholine preserves the gastrointestinal mucosal barrier during LPS-induced inflammation. Shock. 2008 Dec;30(6):729-33. doi: 10.1097/SHK.0b013e318173e8d4.

  PMID: 18496240 BACKGROUND

• Park EJ, Suh M, Thomson B, Ma DW, Ramanujam K, Thomson AB, Clandinin MT. Dietary ganglioside inhibits acute inflammatory signals in intestinal mucosa and blood induced by systemic inflammation of Escherichia coli lipopolysaccharide. Shock. 2007 Jul;28(1):112-7. doi: 10.1097/SHK.0b013e3180310fec.

  PMID: 17510604 BACKGROUND

• Beals E, Kamita SG, Sacchi R, Demmer E, Rivera N, Rogers-Soeder TS, Gertz ER, Van Loan MD, German JB, Hammock BD, Smilowitz JT, Zivkovic AM. Addition of milk fat globule membrane-enriched supplement to a high-fat meal attenuates insulin secretion and induction of soluble epoxide hydrolase gene expression in the postprandial state in overweight and obese subjects. J Nutr Sci. 2019 Apr 26;8:e16. doi: 10.1017/jns.2019.11. eCollection 2019.

  PMID: 31080589 RESULT

• Rogers TS, Demmer E, Rivera N, Gertz ER, German JB, Smilowitz JT, Zivkovic AM, Van Loan MD. The role of a dairy fraction rich in milk fat globule membrane in the suppression of postprandial inflammatory markers and bone turnover in obese and overweight adults: an exploratory study. Nutr Metab (Lond). 2017 May 17;14:36. doi: 10.1186/s12986-017-0189-z. eCollection 2017.

  PMID: 28529534 RESULT

• Demmer E, Van Loan MD, Rivera N, Rogers TS, Gertz ER, German JB, Smilowitz JT, Zivkovic AM. Addition of a dairy fraction rich in milk fat globule membrane to a high-saturated fat meal reduces the postprandial insulinaemic and inflammatory response in overweight and obese adults. J Nutr Sci. 2016 Mar 7;5:e14. doi: 10.1017/jns.2015.42. eCollection 2016.

  PMID: 27313850 RESULT

Related Links

• More information about the research is available on the UC Davis Foods for Health Institute's website

MeSH Terms

Conditions

Metabolic Syndrome; Obesity

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2013
• First Posted: March 14, 2013
• Study Start: August 1, 2013
• Primary Completion: June 17, 2014
• Study Completion (Estimated): January 29, 2027
• Last Updated: December 15, 2025

Record last verified: 2025-12

Locations

US (1)