Effect of Ultra-processed Versus Unprocessed Diets on Energy Metabolism

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

Interventions

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

Sponsors & Collaborators

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

  lead NIH

Principal Investigators

• Valerie L Darcey · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-11-04

Primary Completion

2025-08-15

Completion

2025-08-15

Countries

• United States

Study Locations