Clinical trial NCT02918422: 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
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome X
Keywords: Diet Intervention
Metabolic Syndrome
Feeding Study
Prediabetes
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2016-09-29
Enrollment: 16
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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).

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.

Primary outcomes:
measure: Change in Plasma Fatty Acid Composition and Lipoprotein Analysis
timeFrame: Through study completion, an average of 2 years.
Secondary outcomes:
measure: Change in Body Composition as Assessed by DEXA and MRI
timeFrame: Through study completion, an average of 2 years.
measure: Change in Blood-based Inflammation Markers
timeFrame: Through study completion, an average of 2 years.
measure: Change in Blood Metabolite Profiles
timeFrame: Through study completion, an average of 2 years.
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Physical Activity and Education Services - PAES
state: Ohio
Study officials:
affiliation: Ohio State University
name: Jeff Volek, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.