Determinants and Outcomes of High Vs. Low Ultra-processed Feeding
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Fat Mass Percentage
研究概览
简要总结
The goal of this clinical trial is to learn about, test, and compare health outcomes of high vs. low-processed feeding. The main question[s] it aims to answer are:
• Does consuming a diet rich in unprocessed food improve various health outcomes? Participants will either be instructed to consume a diet rich in unprocessed food for 6 months, or consume their typical diet for 6 months. At various points in the study there will be metabolic health data collected.
If there is a comparison group: Researchers will compare the low-processed group to the typical diet group to see if there are improvements in metabolic health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •rural county resident
- •not meeting physical activity guidelines for adults
- •consuming a typical Western diet (rich in UPF)
排除标准
- •chronic diseases
- •tobacco, vape, or illicit drug use
- •overly active
- •already on a restrictive diet (e.g., keto, intermittent fasting)
研究组 & 干预措施
Low-Processed Food Group
干预措施: Low-Processed Food Diet (Other)
Typical Diet Group
结局指标
主要结局
Fat Mass Percentage
时间窗: 1 year
Using Dual-energy X-ray absorptiometry(DXA), fat mass percentage will be assessed
Body Weight
时间窗: 1 year
Using a standard scale, body weight in kg will be assessed
Body Composition
时间窗: 1 year
Using Dual-energy X-ray absorptiometry(DXA), body composition will be assessed
Fat-Free Mass Percentage
时间窗: 1 year
Using Dual-energy X-ray absorptiometry(DXA), fat-free mass will be assessed
次要结局
- Triglyceride Levels(1 year)
- Cholesterol Levels(1 year)
- HDL(1 year)
- LDL(1 year)
- Alanine transaminase (ALT)(1 year)
- Glucose Levels(1 year)
- Aspartate transaminase (AST)(1 year)