Effect of Ultra-processed Versus Unprocessed Diets on Energy Metabolism

Sponsor

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

Overall Status

Not yet recruiting

CT.gov ID

NCT05290064

Collaborator

(none)

200

Enrollment

Location

Arms

Anticipated Duration (Months)

11.1

Patients Per Site Per Month

Study Details

Study Description

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 collection using a catheter

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

...

Condition or Disease	Intervention/Treatment	Phase
Healthy Diet Obesity	Other: Ultra-processed food, high energy density Other: Ultra-processed food, both low Other: Ultra-processed food, both high Other: Unprocessed food diet	N/A

Detailed Description

Study Description: This is a randomized crossover study of adult volunteers to determine differences in mean ad libitum energy intake when exposed to 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 Aims: Differences in mean daily ad libitum energy intake between four, 1-week test diets

Secondary Aims: Differences in eating rate and palatability of meals

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 Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Effect of Ultra-processed Versus Unprocessed Diets on Energy Metabolism

Anticipated Study Start Date :

Aug 30, 2022

Anticipated Primary Completion Date :

Jan 24, 2024

Anticipated Study Completion Date :

Feb 29, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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 arms 1and 2, arms 1 and 3, arms 2 and 4, and arms 3 and 4.

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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
Stated willingness to comply with all study procedures and availability for the duration of the study
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
Agreement to adhere to Lifestyle Considerations throughout study duration
Ability of subject to understand and the willingness to sign a written informed consent document.

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