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Controlled Clinical Study to Determine Novel Health Benefits of Cheese Consumption

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02918422
Enrollment
16
Registered
2016-09-29
Start date
2015-09-30
Completion date
2018-12-31
Last updated
2019-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome X

Keywords

Diet Intervention, Metabolic Syndrome, Feeding Study, Prediabetes

Brief summary

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

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).

Interventions

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.

Sponsors

Ohio State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 65 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Plasma Fatty Acid Composition and Lipoprotein AnalysisThrough 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

MeasureTime frameDescription
Change in Body Composition as Assessed by DEXA and MRIThrough 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 MarkersThrough 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 ProfilesThrough study completion, an average of 2 years.NMR spectroscopy (600 Mhz) will be used to obtain metabolic profiles of serum samples.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026