跳至主要内容
临床试验/NCT02918422
NCT02918422已完成不适用

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

Ohio State University2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2015年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
2
主要终点
Change in Plasma Fatty Acid Composition and Lipoprotein Analysis

研究概览

简要总结

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

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
None

入排标准

年龄范围
21 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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.

研究组 & 干预措施

High Carbohydrate No Cheese

Experimental

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.

干预措施: Nutritional and Dietary Manipulation (Other)

High Carbohydrate High Cheese

Experimental

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.

干预措施: Nutritional and Dietary Manipulation (Other)

Mod. Carbohydrate High Cheese

Experimental

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.

干预措施: Nutritional and Dietary Manipulation (Other)

Low Carbohydrate High Cheese

Experimental

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.

干预措施: Nutritional and Dietary Manipulation (Other)

结局指标

主要结局

Change in Plasma Fatty Acid Composition and Lipoprotein Analysis

时间窗: 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.

次要结局

  • 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.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeff Volek

Professor

Ohio State University

研究点 (2)

Loading locations...

相似试验

Controlled Clinical Study to Determine Novel Health... | 临床试验