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

Primary Purpose

Metabolic Syndrome, Obesity

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cheddar cheese
Vegan cheese
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 Type

Experimental

Active Comparator

Arm Label

Cheese

Vegan cheese

Arm Description

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.

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.

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.
Plasma lipoprotein size distribution
Plasma lipoprotein size distribution and lipoprotein concentrations will be measured by LipoScience using NMR spectroscopy.
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
February 28, 2013
Last Updated
September 27, 2022
Sponsor
University of California, Davis
Collaborators
Dairy Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01803633
Brief Title
Determine How Consumption of Dairy Fat as Cheese Influences Inflammation-Phase 2
Official Title
Effects of Dairy Fat on Postprandial Inflammation- Phase 2
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 1, 2012 (Actual)
Primary Completion Date
August 13, 2013 (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 2 of this study involves determining how consumption of cheese compared with a non-dairy cheese substitute influences inflammation over a six hour period.
Detailed Description
Phase 2 is a randomized crossover study designed to determine how consumption of cheese compared with a non-dairy cheese substitute influences postprandial inflammation in participants who have 2 or more risk factors of metabolic syndrome or BMI ≥ 30. 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 (cheese or non-dairy cheese substitute). 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 a second test day two weeks after the first test. On the second 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
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cheese
Arm Type
Experimental
Arm Description
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.
Arm Title
Vegan cheese
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Cheddar cheese
Intervention Description
Tillamook medium cheddar cheese brand
Intervention Type
Other
Intervention Name(s)
Vegan cheese
Intervention Description
Daiya brand vegan cheese
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
0, 1, 3, 6 hr 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
0, 1, 3, 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
0, 1, 3, 6 hours postprandial
Title
Urinary metabolites
Description
Urinary metabolites will be measured by nuclear magnetic resonance (NMR) spectroscopy.
Time Frame
0, 1, 3, 6 hours postprandial
Title
Plasma glucose
Description
Plasma glucose will be measured by enzymatic analysis by UC Davis Pathology Lab.
Time Frame
0, 1, 3, 6 hours postprandial
Title
Plasma lipoprotein size distribution
Description
Plasma lipoprotein size distribution and lipoprotein concentrations will be measured by LipoScience using NMR spectroscopy.
Time Frame
0, 1, 3, 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
0, 1, 3, 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
University of California, 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 D. 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

Citations:
PubMed Identifier
21270379
Citation
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.
Results Reference
background
PubMed Identifier
22810464
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.
Results Reference
background
PubMed Identifier
21896876
Citation
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.
Results Reference
background
PubMed Identifier
15533268
Citation
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.
Results Reference
background
PubMed Identifier
15047684
Citation
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.
Results Reference
background
PubMed Identifier
27313852
Citation
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.
Results Reference
result
PubMed Identifier
27258098
Citation
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.
Results Reference
result
Links:
URL
http://ffhi.ucdavis.edu/human-studies/dairy-fat-inflammation
Description
Link to the UC Davis Foods for Health Institute where more information about this research project is available.

Learn more about this trial

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

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