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Effect of Ultra Processed Versus Unprocessed Diets on Energy Intake

NCT03407053 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-06-29

Study results available
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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

Conditions

  • Healthy Diet

Interventions

DIETARY_SUPPLEMENT

Ultra-processed diet

Consuming ultra-processed diet over a 2-week period

DIETARY_SUPPLEMENT

Unprocessed diet

Consuming unprocessed diet over a 2-week period

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    lead NIH

Principal Investigators

  • Kevin Hall, Ph.D. · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2020-02-26
Completion
2020-02-26

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03407053 on ClinicalTrials.gov