Determine How Consumption of Dairy Fat as Cheese Influences Inflammation-Phase 2

NCT01803633 | Active Not Recruiting

• 1 other identifier: 264297
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Phase 2 of this study involves determining how consumption of cheese compared with a non-dairy cheese substitute influences inflammation over 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.

  0, 1, 3, 6 hr postprandial

Secondary Outcomes (6)

• Plasma lipid profile

  0, 1, 3, 6 hours postprandial

• Plasma bone markers

  0, 1, 3, 6 hours postprandial

• Urinary metabolites

  0, 1, 3, 6 hours postprandial

• Plasma glucose

  0, 1, 3, 6 hours postprandial

• Plasma lipoprotein size distribution

  0, 1, 3, 6 hours postprandial

Study Arms (2)

Cheese

EXPERIMENTAL

Cheese sandwich plus supplemental beverage will deliver 40% of each participants' energy expenditure and will be made up of 50% of energy as fat, 35% of energy as carbohydrate and 15% of energy as protein. The sandwich will contain medium cheddar cheese and whole wheat bread. The supplemental beverage will contain fruit sorbet, glucose polymer, protein powder, high oleic sunflower oil, high polyunsaturated fatty acids (PUFA) sunflower oil, and canola oil.

Other: Cheddar cheese

Vegan cheese

ACTIVE COMPARATOR

Non-dairy cheese alternative sandwich plus supplemental beverage will deliver 40% of each participants' energy expenditure and will be made up of 50% of energy as fat, 35% of energy as carbohydrate and 15% of energy as protein. The sandwich will contain vegan cheese and whole wheat bread. The supplemental beverage will contain fruit sorbet, glucose polymer, protein powder, cream of tartar, high oleic sunflower oil, high PUFA sunflower oil, and palm oil.

Other: Vegan cheese

Interventions

Cheddar cheese OTHER

Tillamook medium cheddar cheese brand

Cheese

Vegan cheese OTHER

Daiya brand vegan cheese

Vegan cheese

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 (7)

• 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

• Hostmark AT, Tomten SE. The Oslo health study: cheese intake was negatively associated with the metabolic syndrome. J Am Coll Nutr. 2011 Jun;30(3):182-90. doi: 10.1080/07315724.2011.10719959.

  PMID: 21896876 BACKGROUND

• Biong AS, Muller H, Seljeflot I, Veierod MB, Pedersen JI. A comparison of the effects of cheese and butter on serum lipids, haemostatic variables and homocysteine. Br J Nutr. 2004 Nov;92(5):791-7. doi: 10.1079/bjn20041257.

  PMID: 15533268 BACKGROUND

• Tholstrup T, Hoy CE, Andersen LN, Christensen RD, Sandstrom B. Does fat in milk, butter and cheese affect blood lipids and cholesterol differently? J Am Coll Nutr. 2004 Apr;23(2):169-76. doi: 10.1080/07315724.2004.10719358.

  PMID: 15047684 BACKGROUND

• Demmer E, Van Loan MD, Rivera N, Rogers TS, Gertz ER, German JB, Zivkovic AM, Smilowitz JT. Consumption of a high-fat meal containing cheese compared with a vegan alternative lowers postprandial C-reactive protein in overweight and obese individuals with metabolic abnormalities: a randomised controlled cross-over study. J Nutr Sci. 2016 Feb 9;5:e9. doi: 10.1017/jns.2015.40. eCollection 2016.

  PMID: 27313852 RESULT

• Zeng NF, Mancuso JE, Zivkovic AM, Smilowitz JT, Ristenpart WD. Red Blood Cells from Individuals with Abdominal Obesity or Metabolic Abnormalities Exhibit Less Deformability upon Entering a Constriction. PLoS One. 2016 Jun 3;11(6):e0156070. doi: 10.1371/journal.pone.0156070. eCollection 2016.

  PMID: 27258098 RESULT

Related Links

• Link to the UC Davis Foods for Health Institute where more information about this research project is available.

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

  University of California, 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 D. 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: February 28, 2013
• First Posted: March 4, 2013
• Study Start: September 1, 2012
• Primary Completion: August 13, 2013
• Study Completion (Estimated): January 29, 2027
• Last Updated: December 15, 2025

Record last verified: 2025-12

Locations

US (1)