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Clinical Trials/NCT03407053
NCT03407053
Completed
Not Applicable

Effect of Ultra Processed Versus Unprocessed Diets on Energy Intake

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)1 site in 1 country20 target enrollmentMarch 1, 2018
ConditionsHealthy Diet

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy Diet
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Enrollment
20
Locations
1
Primary Endpoint
Ad Libitum Energy Intake
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2018
End Date
February 26, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Ad Libitum Energy Intake

Time Frame: 14 days

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

Secondary Outcomes

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

Study Sites (1)

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