Metabolic SyndromeNCT01803633
Determine How Consumption of Dairy Fat as Cheese Influences Inflammation-Phase 2
A study testing Cheddar cheese and Vegan cheese in people with Metabolic Syndrome and Obesity, run by University of California, Davis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Obesity
- What is being tested?
- Cheddar cheese and Vegan cheese
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2012to 29 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 30Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
USDA Western Human Nutrition Research Center
Davis, California, 95616
About this study
Official title: Effects of Dairy Fat on Postprandial Inflammation- Phase 2
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.
Read the 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.
- Conditions
- Metabolic Syndrome, Obesity
- Being tested
- Cheddar cheese, Vegan cheese
- Medical subject headings
- Metabolic Syndrome, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cheddar cheeseOther
Tillamook medium cheddar cheese brand
Vegan cheeseOther
Daiya brand vegan cheese
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Vegan cheese |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma inflammatory mediators
Plasma cytokines will be measured using a multi-plex immunoassay and plasma oxylipins will be measured by mass spectroscopy.
Measured: 0, 1, 3, 6 hr postprandial
Secondary outcomes (6)
Plasma lipid profile
Plasma lipids (triglycerides, total cholesterol, LDL-C, HDL-C) will be measured by enzymatic analysis by UC Davis Pathology Lab.
Measured: 0, 1, 3, 6 hours postprandial
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.
Measured: 0, 1, 3, 6 hours postprandial
Urinary metabolites
Urinary metabolites will be measured by nuclear magnetic resonance (NMR) spectroscopy.
Measured: 0, 1, 3, 6 hours postprandial
Plasma glucose
Plasma glucose will be measured by enzymatic analysis by UC Davis Pathology Lab.
Measured: 0, 1, 3, 6 hours postprandial
Plasma lipoprotein size distribution
Plasma lipoprotein size distribution and lipoprotein concentrations will be measured by LipoScience using NMR spectroscopy.
Measured: 0, 1, 3, 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.
Measured: 0, 1, 3, 6 hours postprandial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2013 (estimated)
- Study start1 Sep 2012
- Primary completion13 Aug 2013
- Study completion29 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Dairy Research Institute
- Responsible party
- Sponsor
- Investigators
- Jennifer T. Smilowitz, PhD, Principal investigator, University of California, DavisAngela M. Zivkovic, PhD, Principal investigator, University of California, DavisMarta Van Loan, PhD, Principal investigator, ARS USDA WHNRCJ. Bruce German, PhD, Principal investigator, UC DavisBruce D. Hammock, PhD, Principal investigator, UC Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01803633
- Sponsor's protocol ID
- 264297
- Status last verified
- Dec 2025
- First submitted
- 28 Feb 2013
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21270379Kratz 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.
PubMed 22810464Hostmark 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.
PubMed 21896876Biong 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.
PubMed 15533268Tholstrup 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.
PubMed 15047684Demmer 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.
PubMed 27313852Zeng 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.
PubMed 27258098
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dairy Fat on Postprandial Inflammation- Phase 2
- ClinicalTrials.gov ID
- NCT01803633
- Acronym / sponsor ID
- 264297
- Conditions
- Metabolic Syndrome, Obesity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Dairy Research Institute
- Study start
- 1 Sep 2012 (actual)
- Primary completion
- 13 Aug 2013 (actual)
- Study completion
- 29 Jan 2027 (estimated)
- First posted
- 4 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cheese | Experimental | Other: Cheddar cheeseCheese 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. |
| Vegan cheese | Active comparator | Other: Vegan cheeseNon-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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (30 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cheddar cheeseTillamook medium cheddar cheese brand | Other | Cheese |
| Vegan cheeseDaiya brand vegan cheese | Other | Vegan cheese |
Primary outcome
Plasma inflammatory mediators
Time frame: 0, 1, 3, 6 hr postprandial
Plasma cytokines will be measured using a multi-plex immunoassay and plasma oxylipins will be measured by mass spectroscopy.
6 secondary outcomes
Plasma lipid profile
Time frame: 0, 1, 3, 6 hours postprandial
Plasma bone markers
Time frame: 0, 1, 3, 6 hours postprandial
Urinary metabolites
Time frame: 0, 1, 3, 6 hours postprandial
Plasma glucose
Time frame: 0, 1, 3, 6 hours postprandial
Plasma lipoprotein size distribution
Time frame: 0, 1, 3, 6 hours postprandial
Red blood cell functionality
Time frame: 0, 1, 3, 6 hours postprandial
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Background: PubMed 21270379Astrup 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.
- Background: PubMed 22810464Kratz 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.
- Background: PubMed 21896876Hostmark 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.
- Background: PubMed 15533268Biong 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.
- Background: PubMed 15047684Tholstrup 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 publication: PubMed 27313852Demmer 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 publication: PubMed 27258098Zeng 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.
- Link to the UC Davis Foods for Health Institute where more information about this research project is available.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer T. Smilowitz, PhD principal investigator
University of California, Davis
Angela M. Zivkovic, PhD principal investigator
University of California, Davis
Marta Van Loan, PhD principal investigator
ARS USDA WHNRC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cheddar cheese and Vegan cheese in people with Metabolic Syndrome and Obesity, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma inflammatory mediators (time frame: 0, 1, 3, 6 hr postprandial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01803633, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.