Effect of Ultra-processed Versus Unprocessed Diets on Energy Metabolism

NCT05290064 | Completed

• 2 other identifiers: 22000222-DK-0002
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Protocol Number: 22DK0002 Title: Effects of Ultra-processed versus Unprocessed Diets on Energy Metabolism Background: Many diets worldwide include both processed and unprocessed foods. Researchers want to study the effects these foods have on a person s health. Objective: To study how different diets affect a person s health and metabolism. Eligibility: Adults aged 18 60 without diabetes who have stable weight and can exercise. Design: Participants will be screened with: Medical history Physical exam Heart tests Resting energy expenditure (to determine calorie needs) Blood and urine tests 20-minute stationary bicycle session Food, diet, and mental health questionnaires Participants will stay at NIH for 4 weeks. They will receive 3 meals a day and may eat as little or as much as they want. The diet will change each week. Their weight will be recorded daily. They will ride a stationary bicycle daily. Each week, they will do the following: Spend 1 day in a special room that assesses their metabolism Have 24-hour urine collections Give skin and fecal samples Repeat some screening tests Have scans to measure body fat Complete computerized behavior tasks Wear an activity monitor to track physical activity Wear a glucose monitor. A sensor will be inserted under the skin with a small needle. It will be replaced weekly. Take taste tests. They will swish water and flavored liquids around in their mouth and pick which ones had a non-neutral taste. They will also compare liquids for which ones taste better. Participation will last for 4 weeks. Sponsoring Institution: National Institute of Diabetes and Digestive and Kidney Diseases ...

Conditions

Healthy Diet; Obesity

Keywords

Body Weight; Food Intake; Fat; Calories; Body Mass Index

Outcome Measures

Primary Outcomes (1)

• Energy Metabolism (kcal per day)

  Energy Metabolism averaged over 7 days for each diet, measured in kilocalories (kcal) per day. Primary comparisons will be between UPF HH \& UPF HL, UPF HL \& UPF LL, UPF LL \& UNF LL, UPF HH \& UNF LL.

  Four 1-week diets

Secondary Outcomes (2)

• Meal eating rate (grams per minute)

  Four 1-week diets

• Meal palatability

  Four 1-week diets

Study Arms (4)

1/UPF HH, UPF HL, UNF LL, UPF LL

EXPERIMENTAL

Four diets in the order specified

Other: Ultra-processed food, high energy density; Other: Ultra-processed food, both low; Other: Ultra-processed food, both high; Other: Unprocessed food diet

2/ UPF HL, UPF LL, UPF HH, UNF LL

EXPERIMENTAL

Four diets in the order specified

Other: Ultra-processed food, high energy density; Other: Ultra-processed food, both low; Other: Ultra-processed food, both high; Other: Unprocessed food diet

3/ UPF LL, UNF LL, UPF HL, UPF HH

EXPERIMENTAL

Four diets in the order specified

Other: Ultra-processed food, high energy density; Other: Ultra-processed food, both low; Other: Ultra-processed food, both high; Other: Unprocessed food diet

4/ UNF LL, UPF HH, UPF LL, UPF HL

EXPERIMENTAL

Four diets in the order specified

Other: Ultra-processed food, high energy density; Other: Ultra-processed food, both low; Other: Ultra-processed food, both high; Other: Unprocessed food diet

Interventions

Ultra-processed food, high energy density OTHER

Ultra-processed diet that is high in non-beverage energy density and low in hyperpalatable foods

1/UPF HH, UPF HL, UNF LL, UPF LL; 2/ UPF HL, UPF LL, UPF HH, UNF LL; 3/ UPF LL, UNF LL, UPF HL, UPF HH; 4/ UNF LL, UPF HH, UPF LL, UPF HL

Ultra-processed food, both low OTHER

Ultra-processed diet that is low in both non-beverage energy density and hyperpalatable foods

1/UPF HH, UPF HL, UNF LL, UPF LL; 2/ UPF HL, UPF LL, UPF HH, UNF LL; 3/ UPF LL, UNF LL, UPF HL, UPF HH; 4/ UNF LL, UPF HH, UPF LL, UPF HL

Ultra-processed food, both high OTHER

Ultra-processed diet that is high in both non-beverage energy density and hyperpalatable foods

1/UPF HH, UPF HL, UNF LL, UPF LL; 2/ UPF HL, UPF LL, UPF HH, UNF LL; 3/ UPF LL, UNF LL, UPF HL, UPF HH; 4/ UNF LL, UPF HH, UPF LL, UPF HL

Unprocessed food diet OTHER

Unprocessed diet that is low in both non-beverage energy density and hyperpalatable foods

1/UPF HH, UPF HL, UNF LL, UPF LL; 2/ UPF HL, UPF LL, UPF HH, UNF LL; 3/ UPF LL, UNF LL, UPF HL, UPF HH; 4/ UNF LL, UPF HH, UPF LL, UPF HL

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• Provision of signed and dated informed consent form
• Adults age 18-60 years, male and female
• Weight stable (\< +/- 5 % body weight change over past 6 months) as determined by volunteer report
• Body mass index (BMI) \> =20 kg/m2
• Body weight \> = 53 kg
• Able to complete daily bouts of stationary cycling at a moderate rate and intensity with a HR equal to or greater than 0.3(SqrRoot) (220-age-HRrest)+HRrest but not exceeding 0.4(SqrRoot) (220-age-HRrest)+HRrest and no signs of arrhythmia
• Willingness to comply with all study procedures and Lifestyle Considerations for the duration of the study per the discretion of the PI.

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Evidence of diseases or conditions that may influence appetite (e.g., cancer, diabetes, alterations of smell or taste post COVID-19), or other conditions at the discretion of the PI and/or study team).
• Taking prescription medications or other drugs that may influence appetite (including, but not limited to, diet/weight-loss medication or other medications at the discretion of the PI and/or study team)
• Positive pregnancy test or lactation as determined by volunteer report (women only)
• Participating in a regular exercise program (\> 2h/week of vigorous activity) as determined by volunteer report
• Hematocrit \< 37% (women only)
• Hematocrit \< 40% (men only)
• Caffeine consumption \> 300 mg/day as determined by volunteer report
• Alcohol consumption \> 3 drinks per day for men or \> 2 drinks per day for women as determined by volunteer report
• Regular use of tobacco (smoking or chewing), amphetamines, cocaine, heroin, or marijuana over past 6 months as determined by volunteer report. Subjects may also be excluded based on a urine drug test.
• Psychological conditions as determined by volunteer report such as (but not limited to) eating disorders, depression, bipolar disorders, that would be incompatible with safe and successful participation in this study, as determined by investigators
• Volunteers with strict dietary concerns (e.g. vegetarian or kosher diet, food allergies) or a reported dislike of a significant fraction of the study foods
• Volunteers unwilling or unable to give informed consent

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Obesity; Body Weight; Platelet Glycoprotein IV Deficiency

Interventions

Food, Processed

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Valerie L Darcey

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2022
• First Posted: March 22, 2022
• Study Start: November 4, 2022
• Primary Completion: August 15, 2025
• Study Completion: August 15, 2025
• Last Updated: August 28, 2025

Record last verified: 2025-08-21

Locations

US (1)