Impact of Dietary Guidelines Diets Containing Mostly Ultra-Processed Foods Compared to Less-Processed Foods on Biomarkers of Cardiometabolic Disease
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 79
- 试验地点
- 2
- 主要终点
- Change in blood pressure from baseline
研究概览
简要总结
The purpose of this research is to test how processing food can affect how one's body responds to it.
详细描述
The purpose of this project is to address the current gap in research on ultra-processed foods (UPFs) and cardiometabolic health with a feeding study that addresses the limitations of previously conducted intervention studies in matching UPF- and unprocessed- foods intervention diets for diet quality, nutrient content, and food type. Therefore, the primary objective is to evaluate diets composed primarily of ultra-processed or less processed foods that meet dietary guidelines recommendations on chronic disease risk factors. More specifically, when Dietary Guidelines for Americans (DGA)-compliant diets comprised of mostly ultra-processed and unprocessed foods (per Nova) are fed to generally healthy participants, determine whether there is an impact on:
- blood pressure
- fasting glucose and insulin concentrations, or
- lipid panel (total cholesterol, HDL-C, LDL-C, triglycerides).
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI 18.5-34.9 kg/m2
- •Systolic <139 mm Hg and Diastolic <90 mm Hg
- •Able to understand and sign the consent form
- •Have own transportation to the Grand Forks Human Nutrition Research Center
- •Not allergic to study foods or unwilling to eat them
- •Willing to comply with study demands
- •Able to read and understand English
排除标准
- •Taking statins or medication to lower blood pressure,
- •Taking anti-inflammatory or anti-diabetes medications
- •Pregnant, lactating, or planning to become pregnant
- •Diagnosed with an eating disorder
- •Taking weight loss medications
- •Smoke or use other tobacco products, including e-cigarettes
- •Have overt hypothyroidism
- •Diagnosed with cancer
- •Exercise more than 30 minutes per day 2 or more days per week
- •Allergic to study foods
- •Express unwillingness to consume study foods at the screening appointment
研究组 & 干预措施
Low-processed DGA Diet
Participants will be provided a Dietary Guidelines for Americans (DGA) compliant diet comprised of low-processed foods (Nova Categories 1-3)
干预措施: Low-processed DGA Diet (Other)
Ultra-processed DGA Diet
Participants will be provided a Dietary Guidelines for Americans (DGA) compliant diet comprised primarily of ultra-processed foods (Nova Category 4)
干预措施: Ultra-processed DGA Diet (Other)
结局指标
主要结局
Change in blood pressure from baseline
时间窗: Week 0, Week 4
次要结局
- Change in lipid panel measures (total cholesterol, HDL-C, LDL-C, triglycerides) from baseline(Week 0, Week 4)
- Change in fasting and postprandial glucose and insulin concentrations from baseline(Week 0, Week 4)
研究者
Julie Hess
Research Nutritionist
USDA Grand Forks Human Nutrition Research Center