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

Obesity Clinical Trial

Official title:

Effects of Dairy Fat on Postprandial Inflammation- Phase 1

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01811329
• Other study ID #: 264297-1
• Secondary ID: 264297-1
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 1, 2013
• Est. completion date: January 29, 2027

Study information

• Verified date: November 2023
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 38
• Est. completion date: January 29, 2027
• Est. primary completion date: June 17, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Inflammation
• Metabolic Syndrome
• Obesity

Intervention

Dietary Supplement:
• Dairy fat

• 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.
• Palm fat

• 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.

Locations

Country	Name	City	State
United States	USDA Western Human Nutrition Research Center	Davis	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	Dairy Research Institute

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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 indu — View Citation

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. — View Citation

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. — View Citation

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 over — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 ad — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Plasma lipid profile	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
Secondary	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.	Change from 0 hour up to 6 hours postprandial
Secondary	Urinary metabolites	Urinary metabolites will be measured by nuclear magnetic resonance (NMR) spectroscopy.	Change from 0 hour up to 6 hours postprandial
Secondary	Plasma glucose	Plasma glucose will be measured by enzymatic analysis by UC Davis Pathology Lab.	Change from 0 hour up to 6 hours postprandial
Secondary	Red blood cell functionality	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

External Links

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