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Controlled Clinical Study to Determine Novel Health Benefits of Cheese Consumption

Primary Purpose

Metabolic Syndrome X

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nutritional and Dietary Manipulation
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Metabolic Syndrome X focused on measuring Diet Intervention, Metabolic Syndrome, Feeding Study, Prediabetes

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Physical Activity and Education Services - PAES

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

High Carbohydrate No Cheese

High Carbohydrate High Cheese

Mod. Carbohydrate High Cheese

Low Carbohydrate High Cheese

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12, IL-13 and TNF-α.
Change in Blood Metabolite Profiles
NMR spectroscopy (600 Mhz) will be used to obtain metabolic profiles of serum samples.

Full Information

First Posted
February 25, 2016
Last Updated
August 27, 2019
Sponsor
Ohio State University
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1. Study Identification

Unique Protocol Identification Number
NCT02918422
Brief Title
Controlled Clinical Study to Determine Novel Health Benefits of Cheese Consumption
Official Title
Controlled Feeding Study to Show Effects of Manipulating Carbohydrate and Cheese on Health Markers In Individuals With Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome X
Keywords
Diet Intervention, Metabolic Syndrome, Feeding Study, Prediabetes

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Carbohydrate No Cheese
Arm Type
Experimental
Arm Description
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.
Arm Title
High Carbohydrate High Cheese
Arm Type
Experimental
Arm Description
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.
Arm Title
Mod. Carbohydrate High Cheese
Arm Type
Experimental
Arm Description
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.
Arm Title
Low Carbohydrate High Cheese
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Nutritional and Dietary Manipulation
Intervention Description
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 Outcome Measure Information:
Title
Change in Plasma Fatty Acid Composition and Lipoprotein Analysis
Description
Blood analysis for Fatty Acid Composition and Lipoproteins will by conducted by Lipid Technologies and Quest Diagnostics, respectively.
Time Frame
Through study completion, an average of 2 years.
Secondary Outcome Measure Information:
Title
Change in Body Composition as Assessed by DEXA and MRI
Description
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.
Time Frame
Through study completion, an average of 2 years.
Title
Change in Blood-based Inflammation Markers
Description
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.
Time Frame
Through study completion, an average of 2 years.
Title
Change in Blood Metabolite Profiles
Description
NMR spectroscopy (600 Mhz) will be used to obtain metabolic profiles of serum samples.
Time Frame
Through study completion, an average of 2 years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeff Volek, PhD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Physical Activity and Education Services - PAES
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Final results will be published via peer-review process.
Citations:
PubMed Identifier
31217353
Citation
Hyde PN, Sapper TN, Crabtree CD, LaFountain RA, Bowling ML, Buga A, Fell B, McSwiney FT, Dickerson RM, Miller VJ, Scandling D, Simonetti OP, Phinney SD, Kraemer WJ, King SA, Krauss RM, Volek JS. Dietary carbohydrate restriction improves metabolic syndrome independent of weight loss. JCI Insight. 2019 Jun 20;4(12):e128308. doi: 10.1172/jci.insight.128308. eCollection 2019 Jun 20.
Results Reference
derived

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Controlled Clinical Study to Determine Novel Health Benefits of Cheese Consumption

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