Controlled Feeding Study to Show Effects of Manipulating Carbohydrate and Cheese on Health Markers In Individuals With Metabolic Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ohio State University
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Change in Plasma Fatty Acid Composition and Lipoprotein Analysis
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •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.
Arms & Interventions
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.
Intervention: Nutritional and Dietary Manipulation (Other)
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.
Intervention: Nutritional and Dietary Manipulation (Other)
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.
Intervention: Nutritional and Dietary Manipulation (Other)
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.
Intervention: Nutritional and Dietary Manipulation (Other)
Outcomes
Primary Outcomes
Change in Plasma Fatty Acid Composition and Lipoprotein Analysis
Time Frame: 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 Outcomes
- Change in Blood-based Inflammation Markers(Through study completion, an average of 2 years.)
- Change in Body Composition as Assessed by DEXA and MRI(Through study completion, an average of 2 years.)
- Change in Blood Metabolite Profiles(Through study completion, an average of 2 years.)
Investigators
Jeff Volek
Professor
Ohio State University