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Controlled Clinical Study to Determine Novel Health Benefits of Cheese Consumption

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ClinicalTrials.gov Identifier: NCT02918422
Recruitment Status : Active, not recruiting
First Posted : September 29, 2016
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
Jeff Volek, Ohio State University

Study Description
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Brief Summary:
To determine the effects of high cheese diets varying in carbohydrate content on markers of disease risk.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome X Other: Nutritional and Dietary Manipulation Not Applicable

Detailed Description:

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 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
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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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
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
United States, Ohio
Physical Activity and Education Services - PAES
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
Investigators
Principal Investigator: Jeff Volek, PhD Ohio State University
More Information
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Responsible Party: Jeff Volek, Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT02918422     History of Changes
Other Study ID Numbers: GRT00036921
60047084 ( Other Grant/Funding Number: Dairy Management Inc )
First Posted: September 29, 2016    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Final results will be published via peer-review process.

Keywords provided by Jeff Volek, Ohio State University:
Diet Intervention
Metabolic Syndrome
Feeding Study
Prediabetes

Additional relevant MeSH terms:
Syndrome
Metabolic Syndrome X
Disease
Pathologic Processes
 Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases