Controlled Clinical Study to Determine Novel Health Benefits of Cheese Consumption

NCT ID: NCT02918422

Last Updated: 2019-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2018-12-31

Brief Summary

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

Detailed Description

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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).

Conditions

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Metabolic Syndrome X

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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High Carbohydrate No Cheese

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.

Group Type EXPERIMENTAL

Nutritional and Dietary Manipulation

Intervention Type 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.

High Carbohydrate High Cheese

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.

Group Type EXPERIMENTAL

Nutritional and Dietary Manipulation

Intervention Type 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.

Mod. Carbohydrate High Cheese

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.

Group Type EXPERIMENTAL

Nutritional and Dietary Manipulation

Intervention Type 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.

Low Carbohydrate High Cheese

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.

Group Type EXPERIMENTAL

Nutritional and Dietary Manipulation

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ohio State University

OTHER

Sponsor Role lead

Responsible Party

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Jeff Volek

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeff Volek, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

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Physical Activity and Education Services - PAES

Columbus, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 31217353 (View on PubMed)

Other Identifiers

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60047084

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

GRT00036921

Identifier Type: -

Identifier Source: org_study_id

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