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Effect of Ultra Processed Versus Unprocessed Diets on Energy Intake

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ClinicalTrials.gov Identifier: NCT03407053
Recruitment Status : Completed
First Posted : January 23, 2018
Results First Posted : June 29, 2021
Last Update Posted : June 29, 2021
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )

Study Description
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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

Condition or disease Intervention/treatment Phase
Healthy Diet Dietary Supplement: Ultra-processed diet Dietary Supplement: Unprocessed diet Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of Ultra Processed Versus Unprocessed Diets on Energy Intake
Actual Study Start Date : March 1, 2018
Actual Primary Completion Date : February 26, 2020
Actual Study Completion Date : February 26, 2020
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Ultra-processed diet then unprocessed diet
Participants assigned to this arm will consume ultra-processed diet for two weeks followed by unprocessed diet for two weeks
 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
Active Comparator: Unprocessed diet then ultra-processed diet
Participants assigned to this arm will consume unprocessed diet for two weeks followed by ultra-processed diet for two weeks
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change in Body Weight [ Time Frame: Baseline and day 14 ]
    Change in body weight from baseline to day 14 for each diet, measured in kilograms (kg)

  2. Change in Fat Mass [ Time Frame: 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

  • 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 heart rate (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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03407053


Locations
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United States, Maryland
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Kevin Hall, Ph.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  Study Documents (Full-Text)

Documents provided by National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ):
Study Protocol and Statistical Analysis Plan  [PDF] August 17, 2020

More Information
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Additional Information:

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT03407053    
Other Study ID Numbers: 180044
18-DK-0044 ( Other Identifier: NIH Clinical Center )
First Posted: January 23, 2018    Key Record Dates
Results First Posted: June 29, 2021
Last Update Posted: June 29, 2021
Last Verified: January 28, 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ):
Calories
Food Intake
Glucose
Body Composition
Body Weight Regulation