Effect of Ultra-processed Versus Unprocessed Diets on Energy Metabolism

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

...

Study Overview

• Status: Recruiting
• Conditions: Obesity; Healthy Diet
• Intervention / Treatment: Other: Ultra-processed food, high energy density; Other: Ultra-processed food, both low; Other: Ultra-processed food, both high; Other: Unprocessed food diet

Detailed Description

This is a randomized crossover study of adult volunteers to determine the health effects of four different diets varying in non-beverage energy density, hyperpalatable foods, as well as the degree, extent, and purpose of processing according to the NOVA classification system.

Objectives/Endpoints:

Primary Aim:

To determine differences in health effects during four 1-week test diets.

Secondary Aims:

To determine differences in mean eating rate (grams per minute) and palatability of meals between the four 1-week test diets.

Exploratory Aims:

Several exploratory measurements are planned to help comprehensively phenotype the effects of the test diets and are intended to be hypothesis-generating.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nan Zhai, C.R.N.P.; Phone Number: (301) 827-3324; Email: nan.zhai@nih.gov
• Study Contact Backup: Name: Kevin Hall, Ph.D.; Phone Number: (301) 402-8248; Email: kevinh@niddk.nih.gov

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • Recruiting
      • National Institutes of Health Clinical Center
      • Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR); Phone Number: TTY dial 711 800-411-1222; Email: ccopr@nih.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

• INCLUSION CRITERIA:

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.

EXCLUSION CRITERIA:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1/UPF HH, UPF HL, UNF LL, UPF LL; Four diets in the order specified	Other: Ultra-processed food, high energy density; Ultra-processed diet that is high in non-beverage energy density and low in hyperpalatable foods; Other: Ultra-processed food, both low; Ultra-processed diet that is low in both non-beverage energy density and hyperpalatable foods; Other: Ultra-processed food, both high; Ultra-processed diet that is high in both non-beverage energy density and hyperpalatable foods; Other: Unprocessed food diet; Unprocessed diet that is low in both non-beverage energy density and hyperpalatable foods
Experimental: 2/ UPF HL, UPF LL, UPF HH, UNF LL; Four diets in the order specified	Other: Ultra-processed food, high energy density; Ultra-processed diet that is high in non-beverage energy density and low in hyperpalatable foods; Other: Ultra-processed food, both low; Ultra-processed diet that is low in both non-beverage energy density and hyperpalatable foods; Other: Ultra-processed food, both high; Ultra-processed diet that is high in both non-beverage energy density and hyperpalatable foods; Other: Unprocessed food diet; Unprocessed diet that is low in both non-beverage energy density and hyperpalatable foods
Experimental: 3/ UPF LL, UNF LL, UPF HL, UPF HH; Four diets in the order specified	Other: Ultra-processed food, high energy density; Ultra-processed diet that is high in non-beverage energy density and low in hyperpalatable foods; Other: Ultra-processed food, both low; Ultra-processed diet that is low in both non-beverage energy density and hyperpalatable foods; Other: Ultra-processed food, both high; Ultra-processed diet that is high in both non-beverage energy density and hyperpalatable foods; Other: Unprocessed food diet; Unprocessed diet that is low in both non-beverage energy density and hyperpalatable foods
Experimental: 4/ UNF LL, UPF HH, UPF LL, UPF HL; Four diets in the order specified	Other: Ultra-processed food, high energy density; Ultra-processed diet that is high in non-beverage energy density and low in hyperpalatable foods; Other: Ultra-processed food, both low; Ultra-processed diet that is low in both non-beverage energy density and hyperpalatable foods; Other: Ultra-processed food, both high; Ultra-processed diet that is high in both non-beverage energy density and hyperpalatable foods; Other: Unprocessed food diet; Unprocessed diet that is low in both non-beverage energy density and hyperpalatable foods

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Meal eating rate (grams per minute)	This will be determined by the measured duration of the meals along with the measured mass of food consumed.	Four 1-week diets
Meal palatability	This will be measured via questionnaires using visual analogue scales.	Four 1-week diets

Collaborators and Investigators

• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Kevin Hall, Ph.D., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Publications and helpful links

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2022
• Primary Completion (Estimated): December 24, 2024
• Study Completion (Estimated): February 28, 2025

Study Registration Dates

• First Submitted: March 19, 2022
• First Submitted That Met QC Criteria: March 19, 2022
• First Posted (Actual): March 22, 2022

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 8, 2024

More Information

Terms related to this study

• Keywords: Food Intake; Body Weight; Fat; Calories; Body Mass Index
• Other Study ID Numbers: 220002; 22-DK-0002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No