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| ID | Type | Description | Link |
|---|---|---|---|
| 18-DK-0044 | Other Identifier | NIH Clinical Center |
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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultra-processed diet then unprocessed diet | Active Comparator | 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 | Active Comparator | Participants assigned to this arm will consume unprocessed diet for two weeks followed by ultra-processed diet for two weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultra-processed diet | Dietary Supplement | Consuming ultra-processed diet over a 2-week period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ad Libitum Energy Intake | Ad libitum energy intake averaged over 14 days for each diet, measured in kilocalories (kcal) per day. | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Weight | Change in body weight from baseline to day 14 for each diet, measured in kilograms (kg) | Baseline and day 14 |
| Change in Fat Mass | 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. |
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INCLUSION CRITERIA:
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:
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)
Pregnancy, lactation (women only)
Participating in a regular exercise program (> 2h/week of vigorous activity)
Caffeine consumption > 300 mg/day
Regular use of alcohol (> 2 drinks per day), tobacco (smoking or chewing) amphetamines, cocaine, heroin, or marijuana over past 6 months
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
Implants, devices, or foreign objects implanted in the body that interfere with the Magnetic Resonance procedures
Volunteers with strict dietary concerns (e.g. vegetarian or kosher diet, food allergies)
Volunteers unwilling or unable to give informed consent
Non-English speakers due to unavailability of required questionnaires in other languages.
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Hall, Ph.D. | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31105044 | Result | Hall KD, Ayuketah A, Brychta R, Cai H, Cassimatis T, Chen KY, Chung ST, Costa E, Courville A, Darcey V, Fletcher LA, Forde CG, Gharib AM, Guo J, Howard R, Joseph PV, McGehee S, Ouwerkerk R, Raisinger K, Rozga I, Stagliano M, Walter M, Walter PJ, Yang S, Zhou M. Ultra-Processed Diets Cause Excess Calorie Intake and Weight Gain: An Inpatient Randomized Controlled Trial of Ad Libitum Food Intake. Cell Metab. 2019 Jul 2;30(1):67-77.e3. doi: 10.1016/j.cmet.2019.05.008. Epub 2019 May 16. | |
| 41475551 |
| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 Ultra-processed diet: Consuming ultra-processed diet over a 2-week period Unprocessed diet: Consuming unprocessed diet over a 2-week period |
| FG001 | 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 Ultra-processed diet: Consuming ultra-processed diet over a 2-week period Unprocessed diet: Consuming unprocessed diet over a 2-week period |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 Ultra-processed diet: Consuming ultra-processed diet over a 2-week period Unprocessed diet: Consuming unprocessed diet over a 2-week period |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Ad Libitum Energy Intake | Ad libitum energy intake averaged over 14 days for each diet, measured in kilocalories (kcal) per day. | Posted | Mean | Standard Error | kcal per day | 14 days |
|
|
During each 14 day diet period
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ultra-processed Diet | Consuming ultra-processed diet over a 14 day period | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kevin Hall, PhD | NIDDK | 301-402-8248 | kevin.hall@nih.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 17, 2020 | May 18, 2021 | Prot_SAP_000.pdf |
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| Unprocessed diet | Dietary Supplement | Consuming unprocessed diet over a 2-week period |
|
| Baseline and day 14 |
| Derived |
| Brunstrom JM, Schatzker M, Rogers PJ, Courville AB, Hall KD, Flynn AN. Consuming an unprocessed diet reduces energy intake: a post-hoc analysis of a randomized controlled trial reveals a role for human nutritional intelligence. Am J Clin Nutr. 2026 Mar;123(3):101183. doi: 10.1016/j.ajcnut.2025.101183. Epub 2025 Dec 29. |
| 40392756 | Derived | Abar L, Steele EM, Lee SK, Kahle L, Moore SC, Watts E, O'Connell CP, Matthews CE, Herrick KA, Hall KD, O'Connor LE, Freedman ND, Sinha R, Hong HG, Loftfield E. Identification and validation of poly-metabolite scores for diets high in ultra-processed food: An observational study and post-hoc randomized controlled crossover-feeding trial. PLoS Med. 2025 May 20;22(5):e1004560. doi: 10.1371/journal.pmed.1004560. eCollection 2025 May. |
| 39755436 | Derived | Hengist A, Ong JA, McNeel K, Guo J, Hall KD. Imprecision nutrition? Intraindividual variability of glucose responses to duplicate presented meals in adults without diabetes. Am J Clin Nutr. 2025 Jan;121(1):74-82. doi: 10.1016/j.ajcnut.2024.10.007. Epub 2024 Dec 2. |
| 39163976 | Derived | Sciarrillo CM, Guo J, Hengist A, Darcey VL, Hall KD. Diet order significantly affects energy balance for diets varying in macronutrients but not ultraprocessing in crossover studies without a washout period. Am J Clin Nutr. 2024 Oct;120(4):953-963. doi: 10.1016/j.ajcnut.2024.08.013. Epub 2024 Aug 18. |
| 37986904 | Derived | Sciarrillo CM, Guo J, Hengist A, Darcey VL, Hall KD. Diet order affects energy balance in randomized crossover feeding studies that vary in macronutrients but not ultra-processing. medRxiv [Preprint]. 2023 Oct 4:2023.10.03.23296501. doi: 10.1101/2023.10.03.23296501. |
| 37276937 | Derived | O'Connor LE, Hall KD, Herrick KA, Reedy J, Chung ST, Stagliano M, Courville AB, Sinha R, Freedman ND, Hong HG, Albert PS, Loftfield E. Metabolomic Profiling of an Ultraprocessed Dietary Pattern in a Domiciled Randomized Controlled Crossover Feeding Trial. J Nutr. 2023 Aug;153(8):2181-2192. doi: 10.1016/j.tjnut.2023.06.003. Epub 2023 Jun 3. |
| 36897799 | Derived | Jaime-Lara RB, Franks AT, Agarwal K, Nawal N, Courville AB, Guo J, Yang S, Brooks BE, Roy A, Taylor K, Darcey VL, LeCheminant JD, Chung S, Forde CG, Hall KD, Joseph PV. No significant salt or sweet taste preference or sensitivity differences following ad libitum consumption of ultra-processed and unprocessed diets: a randomized controlled pilot study. Chem Senses. 2023 Jan 1;48:bjad007. doi: 10.1093/chemse/bjad007. |
| 32766882 | Derived | Howard R, Guo J, Hall KD. Imprecision nutrition? Different simultaneous continuous glucose monitors provide discordant meal rankings for incremental postprandial glucose in subjects without diabetes. Am J Clin Nutr. 2020 Oct 1;112(4):1114-1119. doi: 10.1093/ajcn/nqaa198. |
| 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 Ultra-processed diet: Consuming ultra-processed diet over a 2-week period Unprocessed diet: Consuming unprocessed diet over a 2-week period |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body weight | Body weight in kg | Mean | Standard Deviation | kg |
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| Fat mass | Fat mass measured in kilograms (kg). Body fat mass was measured using Dual-energy X-ray absorptiometry (DXA) measurements. | Mean | Standard Deviation | kg |
|
| Participants |
|
|
| Secondary | Change in Body Weight | Change in body weight from baseline to day 14 for each diet, measured in kilograms (kg) | Posted | Mean | Standard Error | kg | Baseline and day 14 |
|
|
|
| Secondary | Change in Fat Mass | 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. | Posted | Mean | Standard Error | kg | Baseline and day 14 |
|
|
|
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Unprocessed Diet | Consuming unprocessed diet over a 14 day period | 0 | 20 | 0 | 20 | 0 | 20 |
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