Controlled Clinical Study to Determine Novel Health Benefits of Cheese Consumption

Metabolic Syndrome X Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02918422
• Other study ID #: GRT00036921
• Secondary ID: 60047084
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: December 2018

Study information

• Verified date: August 2019
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
United States	Physical Activity and Education Services - PAES	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Plasma Fatty Acid Composition and Lipoprotein Analysis	Blood analysis for Fatty Acid Composition and Lipoproteins will by conducted by Lipid Technologies and Quest Diagnostics, respectively.	Through study completion, an average of 2 years.
Secondary	Change in Body Composition as Assessed by DEXA and MRI	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.	Through study completion, an average of 2 years.
Secondary	Change in Blood-based Inflammation Markers	Inflammatory biomarkers in the blood will be assessed using a Multiplex ELISA system. The inflammatory markers to be measured are: IL-1ß, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12, IL-13 and TNF-a.	Through study completion, an average of 2 years.
Secondary	Change in Blood Metabolite Profiles	NMR spectroscopy (600 Mhz) will be used to obtain metabolic profiles of serum samples.	Through study completion, an average of 2 years.