Controlled Clinical Study to Determine Novel Health Benefits of Cheese Consumption

Not Applicable

Completed

• Conditions: Metabolic Syndrome X
• Interventions: Other: Nutritional and Dietary Manipulation

• Registration Number: NCT02918422
• Lead Sponsor: Ohio State University

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).

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2016-02-25
• Study First Submitted QC: 2016-09-26
• Study First Posted: 2016-09-29
• Primary Completion: 2018-04
• Study Completion: 2018-12
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-27
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Mod. Carbohydrate High Cheese	Nutritional and Dietary Manipulation	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.
High Carbohydrate High Cheese	Nutritional and Dietary Manipulation	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.
High Carbohydrate No Cheese	Nutritional and Dietary Manipulation	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.
Low Carbohydrate High Cheese	Nutritional and Dietary Manipulation	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.

Primary Outcome Measures

Name	Time	Method
Change in Plasma Fatty Acid Composition and Lipoprotein Analysis	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

Name	Time	Method
Change in Blood-based Inflammation Markers	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 Body Composition as Assessed by DEXA and MRI	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 Metabolite Profiles	Through study completion, an average of 2 years.	NMR spectroscopy (600 Mhz) will be used to obtain metabolic profiles of serum samples.

Trial Locations

Locations (1)

Physical Activity and Education Services - PAES; 🇺🇸 Columbus, Ohio, United States