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Completed

NCT Number: NCT02918422

Controlled Clinical Study to Determine Novel Health Benefits of Cheese Consumption

To determine the effects of high cheese diets varying in carbohydrate content on markers of disease risk.

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Key information

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Physical Activity and Education Services - PAES

Columbus, Ohio, 43210, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nutritional and Dietary Manipulation

Other

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Official study title

Controlled Feeding Study to Show Effects of Manipulating Carbohydrate and Cheese on Health Markers In Individuals With Metabolic Syndrome

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Sep 29, 2016
Registry last updated
Aug 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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