Effect of Ultra Processed Versus Unprocessed Diets on Energy Intake

Not Applicable

Completed

Conditions: Healthy Diet

Interventions: Dietary Supplement: Ultra-processed diet
Dietary Supplement: Unprocessed diet

Registration Number: NCT03407053

Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ultra-processed diet then unprocessed diet	Ultra-processed diet	Participants assigned to this arm will consume ultra-processed diet for two weeks followed by unprocessed diet for two weeks
Unprocessed diet then ultra-processed diet	Ultra-processed diet	Participants assigned to this arm will consume unprocessed diet for two weeks followed by ultra-processed diet for two weeks
Unprocessed diet then ultra-processed diet	Unprocessed diet	Participants assigned to this arm will consume unprocessed diet for two weeks followed by ultra-processed diet for two weeks
Ultra-processed diet then unprocessed diet	Unprocessed diet	Participants assigned to this arm will consume ultra-processed diet for two weeks followed by unprocessed diet for two weeks

Primary Outcome Measures

Name	Time	Method
Ad Libitum Energy Intake	14 days	Ad libitum energy intake averaged over 14 days for each diet, measured in kilocalories (kcal) per day.

Secondary Outcome Measures

Name	Time	Method
Change in Body Weight	Baseline and day 14	Change in body weight from baseline to day 14 for each diet, measured in kilograms (kg)
Change in Fat Mass	Baseline and day 14	Change in body fat mass from baseline to day 14 for each diet, measured in kilograms (kg). Body fat mass was measured using Dual-energy X-ray absorptiometry (DXA) measurements.