跳至主要内容
临床试验/NCT03407053
NCT03407053已完成不适用

Effect of Ultra Processed Versus Unprocessed Diets on Energy Intake

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Ad Libitum Energy Intake

研究概览

简要总结

Background:

Eating too much processed food is believed to lead to obesity. But the effect of processed food on energy intake has not been carefully studied. Researchers want to study people s diets for 4 weeks and do specialized tests of the effects. Participants will get two diets. They will have the same calories and nutrients, but one diet will be unprocessed food and the other will be ultra-processed.

Objective:

To better understand how processed and unprocessed foods affect daily food consumption and how the body handles blood sugar.

Eligibility:

Healthy adults ages 18-50 who have stable weight and can exercise

Design:

Participants will not eat for 12 hours. Then they will be screened with:

  • Medical history
  • Physical exam
  • Heart and blood tests
  • Resting energy expenditure test (REE). A hood will collect air exhaled while lying down for 30-40 minutes.
  • Psychiatric questions
  • Questions about mood, eating, sleep, and socioeconomic status
  • 20-minute stationary biking

Female participants will have a urine pregnancy test.

Participants will stay in the clinic for 4 weeks. For 2 weeks they will get a processed diet. For the other 2 weeks they will get an unprocessed diet. Participants cannot use the study period to gain or lose weight.

Participants will have:

  • Meals and snacks provided
  • Daily exercise
  • Blood, urine, and saliva tests
  • To drink a special water and a very sweet liquid
  • REE
  • Scans and X-rays
  • To wear activity monitors and a device to measure blood sugar
  • Several 24-hour periods in a room that measures oxygen and carbon dioxide
  • Repeats of screening questions
  • Questions about hunger and meals
  • Sleep monitoring
  • Taste tests

详细描述

Overconsumption of foods that result from extensive industrial processing is believed to contribute to the development of obesity. Ultra-processed foods now represent most of the calories consumed in America and their contribution to overall diet has increased in parallel with the rise in the prevalence of obesity over the past several decades. While such correlations are suggestive, the effect of industrial processing per se, independent of dietary macronutrient composition, on ad libitum energy intake has not been carefully investigated. Therefore, we will conduct feeding studies in adult men and women to investigate the differences in ad libitum energy intake resulting from consuming test diets for a pair of 2-week periods in a randomized, crossover design during a single 4-week period. The test diets presented to participants will be matched for calories, macronutrient composition, sugar, fiber, and sodium, but one diet will be composed of ultra-processed foods whereas the other diet will be unprocessed foods.

研究设计

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

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Ad Libitum Energy Intake

时间窗: 14 days

Ad libitum energy intake averaged over 14 days for each diet, measured in kilocalories (kcal) per day.

次要结局

  • Change in Body Weight(Baseline and day 14)
  • Change in Fat Mass(Baseline and day 14)

研究者

研究点 (2)

Loading locations...

相似试验