Effect of Ultra Processed Versus Unprocessed Diets on Energy Intake



Status:Recruiting
Conditions:Healthy Studies, Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 50
Updated:1/9/2019
Start Date:March 1, 2018
End Date:December 31, 2020
Contact:Irene T Rozga, R.N.
Email:irene.rozga@nih.gov
Phone:(301) 496-1069

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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

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 a feeding study in 20 adult men and women to
investigate the differences in ad libitum energy intake resulting from consuming two 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.

- INCLUSION CRITERIA:

1. Adults age 18-50 years, male and female

2. Weight stable (< +/- 5 % over past 6 months)

4. Body mass index (BMI) greater than or equal to 18 kg/m^2

5. Willing to cease their habitual caffeine intake during the study, beginning one
week prior to inpatient admission

6. Written informed consent

7. Willing to eat the food provided in the study

8. Able to complete daily bouts of stationary cycling at a moderate rate and intensity
with a HR equal to or greater than 0.3x(220-age-HR(rest))+HR(rest) but not exceeding
0.4x(220-age-HR(rest))+HR(rest) and no signs of arrhythmia

EXCLUSION CRITERIA:

1. Evidence of metabolic or cardiovascular disease, or disease that may influence
metabolism (e.g. cancer, diabetes, thyroid disease)

2. 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)

3. Hematocrit < 34% (women only)

4. Hematocrit < 40% (men only)

5. Pregnancy, lactation (women only)

6. Participating in a regular exercise program (> 2h/week of vigorous activity)

7. Caffeine consumption > 300 mg/day

8. Regular use of alcohol (> 2 drinks per day), tobacco (smoking or chewing)
amphetamines, cocaine, heroin, or marijuana over past 6 months

9. Eating disorders or psychological conditions, such as (but not limited to)
claustrophobia, clinical depression, bi-polar disorders, that would be incompatible
with safe and successful participation in this study, as determined by investigators.

--Past or present history of claustrophobia since part of the protocol will involve
being confined to a small room for whole-body indirect calorimetry and being in an MRI
scanner for liver fat measures

10. Implants, devices, or foreign objects implanted in the body that interfere with the
Magnetic Resonance procedures

11. Volunteers with strict dietary concerns (e.g. vegetarian or kosher diet, food
allergies)

12. Volunteers unwilling or unable to give informed consent

13. Non-English speakers due to unavailability of required questionnaires in other
languages.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
301-496-2563
Phone: 800-411-1222
National Institutes of Health Clinical Center The National Institutes of Health (NIH) Clinical Center in...
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mi
from
Bethesda, MD
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