Effect of Ultra-processed Versus Unprocessed Diets on Energy Metabolism

Obesity Clinical Trial

Official title:

Effect of Ultra-processed Versus Unprocessed Diets on Energy Metabolism

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05290064
• Other study ID #: 220002
• Secondary ID: 22-DK-0002
• Status: Recruiting
• Phase: N/A
• Start date: November 4, 2022
• Est. completion date: February 28, 2025

Study information

• Verified date: June 7, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Nan Zhai, C.R.N.P.
• Phone: (301) 827-3324
• Email: nan.zhai[@]nih.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

...

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 28, 2025
• Est. primary completion date: December 24, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

• 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

Related Conditions & MeSH terms

• Healthy Diet
• Obesity

Intervention

Other:
• Ultra-processed food, high energy density
Ultra-processed diet that is high in non-beverage energy density and low in hyperpalatable foods
• Ultra-processed food, both low
Ultra-processed diet that is low in both non-beverage energy density and hyperpalatable foods
• Ultra-processed food, both high
Ultra-processed diet that is high in both non-beverage energy density and hyperpalatable foods
• Unprocessed food diet
Unprocessed diet that is low in both non-beverage energy density and hyperpalatable foods

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Meal palatability	This will be measured via questionnaires using visual analogue scales.	Four 1-week diets

External Links

•   NIH Clinical Center Detailed Web Page