CompletedNot Applicable

Effect of Ultra Processed Versus Unprocessed Diets on Energy Intake

United States20 participantsStarted 2018-03-01

Plain-language 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

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

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Inclusion criteria

. Adults age 18-50 years, male and female
. Weight stable (\< +/- 5 % over past 6 months)

Exclusion criteria

. Evidence of metabolic or cardiovascular disease, or disease that may influence metabolism (e.g. cancer, diabetes, thyroid disease)
. Taking any prescription medication or other drug that may influence metabolism (e.g. diet/weight-loss medication, asthma medication, blood pressure medication, psychiatric medications, corticosteroids, or other medications at the discretion of the PI and/or study team)
. Hematocrit \< 34% (women only)
. Hematocrit \< 40% (men only)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Ad Libitum Energy Intake

Timeframe: 14 days

Trial details

NCT IDNCT03407053

SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2020-02-26

Results submitted2021-05-18

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