Controlled Clinical Study to Determine Novel Health Benefits of Cheese Consumption
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ClinicalTrials.gov Identifier: NCT02918422 |
Recruitment Status :
Completed
First Posted : September 29, 2016
Last Update Posted : August 28, 2019
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Condition or disease | Intervention/treatment | Phase |
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Metabolic Syndrome X | Other: Nutritional and Dietary Manipulation | Not Applicable |
Summary of Proposed Research:
This project will involve four controlled 4 wk feeding periods in individuals with metabolic syndrome (currently 1/3 of US adults). After a 2 wk run-in period, 20 subjects will be fed one of three diets in a randomized and balanced order: a typical American High-Carb diet high in cheese (6 oz/day), a High-Carb diet low in cheese (0 oz/day), or a Moderate-Carb, high-cheese diet (6 oz/day), Low-Carb, high cheese where cheese displaces an isocaloric amount of carbohydrate. There will be a 2 wk washout period separating trials during which subjects consume their normal diet. Specific menus will be designed for each feeding phase and all food will be prepared for subjects. Testing will occur at baseline and after each feeding period. Measures of cholesterol beyond standard LDL- and HDL-cholesterol will be done by examining lipoprotein particle size, apolipoproteins, and fatty acid composition [i.e., accumulation of saturated fat in blood and tissues, palmitoleic acid (highly linked to cardiovascular disease), and detection of phytanic acid (a uniquely bioactive fatty acid in dairy fat)]. Changes in whole body and regional fat, including measures of visceral fat and liver fat, will be examined non-invasively by dual-energy X-ray absorptiometry (DXA) and magnetic resonance imaging (MRI).
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 16 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | Controlled Feeding Study to Show Effects of Manipulating Carbohydrate and Cheese on Health Markers In Individuals With Metabolic Syndrome |
Study Start Date : | September 2015 |
Actual Primary Completion Date : | April 2018 |
Actual Study Completion Date : | December 2018 |

Arm | Intervention/treatment |
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Experimental: High Carbohydrate No Cheese
Intervention: Nutritional and Dietary Manipulation. This arm will be provided food with an approximate macronutrient breakdown of: 55% CHO, 20% PRO and 25% fat with ~6oz Cheese (gouda or cheddar) per day being used as a fat source.
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Other: Nutritional and Dietary Manipulation
Participants will undertake a controlled feeding intervention. All food will be prepared and delivered to participants by research staff. Participants will be asked to exclusively eat what is provided to them in efforts to control any dietary effects. |
Experimental: High Carbohydrate High Cheese
Intervention: Nutritional and Dietary Manipulation. This arm will be provided food with an approximate macronutrient breakdown of: 55% CHO, 20% PRO 25% and Fat 25% with ~6oz Cheese (gouda or cheddar) per day being used as a fat source.
|
Other: Nutritional and Dietary Manipulation
Participants will undertake a controlled feeding intervention. All food will be prepared and delivered to participants by research staff. Participants will be asked to exclusively eat what is provided to them in efforts to control any dietary effects. |
Experimental: Mod. Carbohydrate High Cheese
Intervention: Nutritional and Dietary Manipulation. This arm will be provided food with an approximate macronutrient breakdown of: 30% CHO, 20% PRO and 50% Fat with ~6oz Cheese (gouda or cheddar) per day being used as a fat source.
|
Other: Nutritional and Dietary Manipulation
Participants will undertake a controlled feeding intervention. All food will be prepared and delivered to participants by research staff. Participants will be asked to exclusively eat what is provided to them in efforts to control any dietary effects. |
Experimental: Low Carbohydrate High Cheese
Intervention: Nutritional and Dietary Manipulation. This arm will be provided food with an approximate macronutrient breakdown of: 10% CHO, 20% PRO and 70% Fat with ~6oz Cheese (gouda or cheddar) per day being used as a fat source.
|
Other: Nutritional and Dietary Manipulation
Participants will undertake a controlled feeding intervention. All food will be prepared and delivered to participants by research staff. Participants will be asked to exclusively eat what is provided to them in efforts to control any dietary effects. |
- Change in Plasma Fatty Acid Composition and Lipoprotein Analysis [ Time Frame: Through study completion, an average of 2 years. ]Blood analysis for Fatty Acid Composition and Lipoproteins will by conducted by Lipid Technologies and Quest Diagnostics, respectively.
- Change in Body Composition as Assessed by DEXA and MRI [ Time Frame: Through study completion, an average of 2 years. ]Participants will undergo both DEXA and MRI scans, conducted by trained professionals. DEXA will be used to determined subcutaneous adiposity. MRI post-imaging analyses will determine both hepatic and visceral fat content.
- Change in Blood-based Inflammation Markers [ Time Frame: Through study completion, an average of 2 years. ]Inflammatory biomarkers in the blood will be assessed using a Multiplex ELISA system. The inflammatory markers to be measured are: IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12, IL-13 and TNF-α.
- Change in Blood Metabolite Profiles [ Time Frame: Through study completion, an average of 2 years. ]NMR spectroscopy (600 Mhz) will be used to obtain metabolic profiles of serum samples.

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Ages Eligible for Study: | 21 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Waist circumference (≥101.6 cm men, ≥88.9 cm women)
- Blood pressure (≥130/85 mm Hg) or current use of antihypertensive medication
- Fasting plasma glucose (≥100 mg/dL)
- Triglycerides (≥150 mg/dL)
- HDL-C (<40 mg/dL men, <50 mg/dL women)
Exclusion Criteria:
- Hypercholesterolemia
- Diabetes
- Liver, kidney or other metabolic or endocrine dysfunction, gastrointestinal disorders
- Regular smokers
- Lactose-intolerant
- Consume excessive amounts of alcohol (>3 drinks/d)
- Have used cholesterol, diabetic, antibiotic or antifungal medications in the past 3 months
- Women who are pregnant or lactating
- Participants taking any probiotics or supplements known to affect serum lipid levels, inflammation, antioxidant status or the gut microbiota will be asked to discontinue use to allow for washout of any metabolic effects.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02918422
United States, Ohio | |
Physical Activity and Education Services - PAES | |
Columbus, Ohio, United States, 43210 |
Principal Investigator: | Jeff Volek, PhD | Ohio State University |
Responsible Party: | Jeff Volek, Professor, Ohio State University |
ClinicalTrials.gov Identifier: | NCT02918422 |
Other Study ID Numbers: |
GRT00036921 60047084 ( Other Grant/Funding Number: Dairy Management Inc ) |
First Posted: | September 29, 2016 Key Record Dates |
Last Update Posted: | August 28, 2019 |
Last Verified: | August 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Final results will be published via peer-review process. |
Diet Intervention Metabolic Syndrome Feeding Study Prediabetes |
Metabolic Syndrome Syndrome Disease Pathologic Processes |
Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases |