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| ID | Type | Description | Link |
|---|---|---|---|
| 264297-1 | Other Identifier | UC Davis IRB |
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| Name | Class |
|---|---|
| Dairy Research Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dairy fat | Dietary Supplement |
| ||
| Dairy fat + MFGM |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Plasma bone markers |
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Inclusion Criteria:
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:
Dietary/supplements:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USDA Western Human Nutrition Research Center | Davis | California | 95616 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21270379 | Background | 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. | |
| 22810464 |
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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 | Dietary Supplement |
|
| 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. |
|
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 | Urinary metabolites will be measured by nuclear magnetic resonance (NMR) spectroscopy. | Change from 0 hour up to 6 hours postprandial |
| Plasma glucose | 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 | 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 |
| 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. |
| 21524510 | 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. |
| 19713204 | 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. |
| 21188562 | 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. |
| 16759708 | 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. |
| 18496240 | 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. |
| 17510604 | 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. |
| 31080589 | Result | 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. |
| 28529534 | 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. |
| 27313850 | 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. |
| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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