Effect of Ultra Processed Versus Unprocessed Diets on Energy Intake

• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT03407053
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Actual Duration (Months): 23.9
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

Background:

Eating too much processed food is believed to lead to obesity. But the effect of processed food on energy intake has not been carefully studied. Researchers want to study people s diets for 4 weeks and do specialized tests of the effects. Participants will get two diets. They will have the same calories and nutrients, but one diet will be unprocessed food and the other will be ultra-processed.

Objective:

To better understand how processed and unprocessed foods affect daily food consumption and how the body handles blood sugar.

Eligibility:

Healthy adults ages 18-50 who have stable weight and can exercise

Design:

Participants will not eat for 12 hours. Then they will be screened with:

• Medical history

• Physical exam

• Heart and blood tests

• Resting energy expenditure test (REE). A hood will collect air exhaled while lying down for 30-40 minutes.

• Psychiatric questions

• Questions about mood, eating, sleep, and socioeconomic status

• 20-minute stationary biking

Female participants will have a urine pregnancy test.

Participants will stay in the clinic for 4 weeks. For 2 weeks they will get a processed diet. For the other 2 weeks they will get an unprocessed diet. Participants cannot use the study period to gain or lose weight.

Participants will have:

• Meals and snacks provided

• Daily exercise

• Blood, urine, and saliva tests

• To drink a special water and a very sweet liquid

• REE

• Scans and X-rays

• To wear activity monitors and a device to measure blood sugar

• Several 24-hour periods in a room that measures oxygen and carbon dioxide

• Repeats of screening questions

• Questions about hunger and meals

• Sleep monitoring

• Taste tests

Condition or Disease	Intervention/Treatment	Phase
Healthy Diet	Dietary Supplement: Ultra-processed diet; Dietary Supplement: Unprocessed diet	N/A

Detailed Description

Overconsumption of foods that result from extensive industrial processing is believed to contribute to the development of obesity. Ultra-processed foods now represent most of the calories consumed in America and their contribution to overall diet has increased in parallel with the rise in the prevalence of obesity over the past several decades. While such correlations are suggestive, the effect of industrial processing per se, independent of dietary macronutrient composition, on ad libitum energy intake has not been carefully investigated. Therefore, we will conduct feeding studies in adult men and women to investigate the differences in ad libitum energy intake resulting from consuming test diets for a pair of 2-week periods in a randomized, crossover design during a single 4-week period. The test diets presented to participants will be matched for calories, macronutrient composition, sugar, fiber, and sodium, but one diet will be composed of ultra-processed foods whereas the other diet will be unprocessed foods.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 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 Intake
• Actual Study Start Date: Mar 1, 2018
• Actual Primary Completion Date: Feb 26, 2020
• Actual Study Completion Date: Feb 26, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Ultra-processed diet then unprocessed diet Participants assigned to this arm will consume ultra-processed diet for two weeks followed by unprocessed diet for two weeks	Dietary Supplement: Ultra-processed diet; Consuming ultra-processed diet over a 2-week period; Dietary Supplement: Unprocessed diet; Consuming unprocessed diet over a 2-week period
Active Comparator: Unprocessed diet then ultra-processed diet Participants assigned to this arm will consume unprocessed diet for two weeks followed by ultra-processed diet for two weeks	Dietary Supplement: Ultra-processed diet; Consuming ultra-processed diet over a 2-week period; Dietary Supplement: Unprocessed diet; Consuming unprocessed diet over a 2-week period

Outcome Measures

Primary Outcome Measures

1. Ad Libitum Energy Intake [14 days]

   Ad libitum energy intake averaged over 14 days for each diet, measured in kilocalories (kcal) per day.

Secondary Outcome Measures

1. Change in Body Weight [Baseline and day 14]

   Change in body weight from baseline to day 14 for each diet, measured in kilograms (kg)

2. Change in Fat Mass [Baseline and day 14]

   Change in body fat mass from baseline to day 14 for each diet, measured in kilograms (kg). Body fat mass was measured using Dual-energy X-ray absorptiometry (DXA) measurements.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

• INCLUSION CRITERIA:

1. Adults age 18-50 years, male and female

2. Weight stable (< +/- 5 % over past 6 months)

3. Body mass index (BMI) greater than or equal to 18 kg/m^2

4. Willing to cease their habitual caffeine intake during the study, beginning one week prior to inpatient admission

5. Written informed consent

6. Willing to eat the food provided in the study

7. Able to complete daily bouts of stationary cycling at a moderate rate and intensity with a heart rate (HR) equal to or greater than 0.3x(220-age-HR(rest))+HR(rest) but not exceeding 0.4x(220-age-HR(rest))+HR(rest) and no signs of arrhythmia

EXCLUSION CRITERIA:

1. Evidence of metabolic or cardiovascular disease, or disease that may influence metabolism (e.g. cancer, diabetes, thyroid disease)

2. Taking any prescription medication or other drug that may influence metabolism (e.g. diet/weight-loss medication, asthma medication, blood pressure medication, psychiatric medications, corticosteroids, or other medications at the discretion of the PI and/or study team)

3. Hematocrit < 34% (women only)

4. Hematocrit < 40% (men only)

5. Pregnancy, lactation (women only)

6. Participating in a regular exercise program (> 2h/week of vigorous activity)

7. Caffeine consumption > 300 mg/day

8. Regular use of alcohol (> 2 drinks per day), tobacco (smoking or chewing) amphetamines, cocaine, heroin, or marijuana over past 6 months

9. Eating disorders or psychological conditions, such as (but not limited to) claustrophobia, clinical depression, bi-polar disorders, that would be incompatible with safe and successful participation in this study, as determined by investigators.

--Past or present history of claustrophobia since part of the protocol will involve being confined to a small room for whole-body indirect calorimetry and being in an MRI scanner for liver fat measures

1. Implants, devices, or foreign objects implanted in the body that interfere with the Magnetic Resonance procedures

2. Volunteers with strict dietary concerns (e.g. vegetarian or kosher diet, food allergies)

3. Volunteers unwilling or unable to give informed consent

4. Non-English speakers due to unavailability of required questionnaires in other languages.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Institutes of Health Clinical Center	Bethesda	Maryland	United States	20892

Sponsors and Collaborators

• 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)

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 17, 2020

More Information

Additional Information:

• NIH Clinical Center Detailed Web Page

Publications

None provided.

• Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• ClinicalTrials.gov Identifier: NCT03407053
• Other Study ID Numbers: 180044; 18-DK-0044
• First Posted: Jan 23, 2018
• Last Update Posted: Jun 29, 2021
• Last Verified: Jan 28, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): Calories; Food Intake; Glucose; Body Composition; Body Weight Regulation

Study Results

Participant Flow

Arm/Group Title	Ultra-processed Diet Then Unprocessed Diet	Unprocessed Diet Then Ultra-processed Diet
Arm/Group Description	Participants assigned to this arm will consume ultra-processed diet for two weeks followed by unprocessed diet for two weeks Ultra-processed diet: Consuming ultra-processed diet over a 2-week period Unprocessed diet: Consuming unprocessed diet over a 2-week period	Participants assigned to this arm will consume unprocessed diet for two weeks followed by ultra-processed diet for two weeks Ultra-processed diet: Consuming ultra-processed diet over a 2-week period Unprocessed diet: Consuming unprocessed diet over a 2-week period
Period Title: Overall Study
STARTED	10	10
COMPLETED	10	10
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Ultra-processed Diet Then Unprocessed Diet	Unprocessed Diet Then Ultra-processed Diet	Total
Arm/Group Description	Participants assigned to this arm will consume ultra-processed diet for two weeks followed by unprocessed diet for two weeks Ultra-processed diet: Consuming ultra-processed diet over a 2-week period Unprocessed diet: Consuming unprocessed diet over a 2-week period	Participants assigned to this arm will consume unprocessed diet for two weeks followed by ultra-processed diet for two weeks Ultra-processed diet: Consuming ultra-processed diet over a 2-week period Unprocessed diet: Consuming unprocessed diet over a 2-week period	Total of all reporting groups
Overall Participants	10	10	20
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	32.3 (6.8)	30.1 (7.8)	31.2 (7.2)
Sex: Female, Male (Count of Participants)
Female	4 40%	6 60%	10 50%
Male	6 60%	4 40%	10 50%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 30%	2 20%	5 25%
Not Hispanic or Latino	7 70%	8 80%	15 75%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 10%	2 20%	3 15%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	4 40%	7 70%	11 55%
White	2 20%	1 10%	3 15%
More than one race	2 20%	0 0%	2 10%
Unknown or Not Reported	1 10%	0 0%	1 5%
Region of Enrollment (participants) [Number]
United States	10 100%	10 100%	20 100%
Body weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	77.3 (21.1)	79.3 (22.4)	78.3 (21.2)
Fat mass (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	23.1 (13.4)	26.0 (14.2)	24.6 (13.5)

Outcome Measures

1. Primary Outcome

Title	Ad Libitum Energy Intake
Description	Ad libitum energy intake averaged over 14 days for each diet, measured in kilocalories (kcal) per day.
Time Frame	14 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ultra-processed Diet	Unprocessed Diet
Arm/Group Description	Consuming ultra-processed diet over a 14 day period	Consuming unprocessed diet over a 14 day period
Measure Participants	20	20
Mean (Standard Error) [kcal per day]	2963 (74.3)	2491 (74.3)

2. Secondary Outcome

Title	Change in Body Weight
Description	Change in body weight from baseline to day 14 for each diet, measured in kilograms (kg)
Time Frame	Baseline and day 14

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ultra-processed Diet	Unprocessed Diet
Arm/Group Description	Consuming ultra-processed diet over a 14 day period	Consuming unprocessed diet over a 14 day period
Measure Participants	20	20
Mean (Standard Error) [kg]	0.94 (0.31)	-0.91 (0.31)

3. Secondary Outcome

Title	Change in Fat Mass
Description	Change in body fat mass from baseline to day 14 for each diet, measured in kilograms (kg). Body fat mass was measured using Dual-energy X-ray absorptiometry (DXA) measurements.
Time Frame	Baseline and day 14

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ultra-processed Diet	Unprocessed Diet
Arm/Group Description	Consuming ultra-processed diet over a 14 day period	Consuming unprocessed diet over a 14 day period
Measure Participants	20	19
Mean (Standard Error) [kg]	0.43 (0.11)	-0.28 (0.11)

Adverse Events

Time Frame	During each 14 day diet period
Arm/Group Title	Ultra-processed Diet		Unprocessed Diet
Arm/Group Description	Consuming ultra-processed diet over a 14 day period		Consuming unprocessed diet over a 14 day period
All Cause Mortality
	Ultra-processed Diet		Unprocessed Diet
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Serious Adverse Events
	Ultra-processed Diet		Unprocessed Diet
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Ultra-processed Diet		Unprocessed Diet
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.