Effect of Ultra-processed Versus Unprocessed Diets on Energy Metabolism

Not Applicable

Recruiting

• Conditions: Healthy Diet; Obesity
• Interventions: Other: Ultra-processed food, high energy density; Other: Ultra-processed food, both low; Other: Ultra-processed food, both high; Other: Unprocessed food diet

• Registration Number: NCT05290064
• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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

...

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 Timeline

• Study First Submitted: 2022-03-19
• Study First Submitted QC: 2022-03-19
• Study First Posted: 2022-03-22
• Study Start: 2022-11-04
• Status Verified: 2025-05-01
• Last Update Submitted: 2025-05-02
• Last Update Posted: 2025-05-04
• Primary Completion: 2025-12-24
• Study Completion: 2025-12-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1/UPF HH, UPF HL, UNF LL, UPF LL	Ultra-processed food, both low	Four diets in the order specified
2/ UPF HL, UPF LL, UPF HH, UNF LL	Ultra-processed food, high energy density	Four diets in the order specified
2/ UPF HL, UPF LL, UPF HH, UNF LL	Ultra-processed food, both low	Four diets in the order specified
3/ UPF LL, UNF LL, UPF HL, UPF HH	Ultra-processed food, both low	Four diets in the order specified
3/ UPF LL, UNF LL, UPF HL, UPF HH	Unprocessed food diet	Four diets in the order specified
2/ UPF HL, UPF LL, UPF HH, UNF LL	Ultra-processed food, both high	Four diets in the order specified
4/ UNF LL, UPF HH, UPF LL, UPF HL	Ultra-processed food, both low	Four diets in the order specified
3/ UPF LL, UNF LL, UPF HL, UPF HH	Ultra-processed food, both high	Four diets in the order specified
1/UPF HH, UPF HL, UNF LL, UPF LL	Ultra-processed food, both high	Four diets in the order specified
1/UPF HH, UPF HL, UNF LL, UPF LL	Unprocessed food diet	Four diets in the order specified
2/ UPF HL, UPF LL, UPF HH, UNF LL	Unprocessed food diet	Four diets in the order specified
3/ UPF LL, UNF LL, UPF HL, UPF HH	Ultra-processed food, high energy density	Four diets in the order specified
4/ UNF LL, UPF HH, UPF LL, UPF HL	Ultra-processed food, high energy density	Four diets in the order specified
1/UPF HH, UPF HL, UNF LL, UPF LL	Ultra-processed food, high energy density	Four diets in the order specified
4/ UNF LL, UPF HH, UPF LL, UPF HL	Ultra-processed food, both high	Four diets in the order specified
4/ UNF LL, UPF HH, UPF LL, UPF HL	Unprocessed food diet	Four diets in the order specified

Primary Outcome Measures

Name	Time	Method
Energy Metabolism (kcal per day)	Four 1-week diets	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

National Institutes of Health Clinical Center; 🇺🇸 Bethesda, Maryland, United States