ObesityNCT03189121
Effect of Isocaloric Ultra Processed Versus Unprocessed Diets on Insulin Sensitivity
An observational study of Obesity, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
Background: Increases in obesity, diabetes, and some metabolic disorders may be linked to how much processed foods people eat. Researchers want to learn more about how processed foods affect metabolic health. Objective: To learn about how a processed versus unprocessed diet affects the body. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2017to 5 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: 20 overweight and obese adult men.
Who may be able to join
- Adult men, age 18-50 years
- Weight stable (< plus or minus 5 % over past 6 months)
- Body mass index (BMI) greater than or equal to 25 kg/m^2
- Plasma triglycerides > 150 mg/dl (Caucasian) or >140 mg/dl (African American)
- Homeostatic model of insulin resistance (HOMA-IR) > 2
- Able to complete daily bouts of stationary cycling at a moderate rate and intensity with a HR equal to or greater than 0.3x(220-age-HRrest)+HRrest but not exceeding 0.6x(220-age- HRrest)+HRrest and no signs of arrhythmia
Show all 9Show fewer
- Written informed consent
- Willing to eat all the food provided in the study
- Willing to cease their habitual caffeine intake during the study, beginning one week prior to each inpatient admission
Who cannot join
- Evidence of metabolic or cardiovascular disease, or disease that may influence metabolism (e.g. cancer, diabetes, thyroid disease)
- Body weight >400 lbs. (weight limit of magnetic resonance spectroscopy gantry)
- 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)
- Hematocrit < 40%
- Participating in a regular exercise program (> 2h/week of vigorous activity)
- Caffeine consumption > 300 mg/day
Show all 12Show fewer
- Regular use of alcohol (> 2 drinks per day), tobacco (smoking or chewing) amphetamines, cocaine, heroin, or marijuana over past 6 months
- Past or present history of eating disorder (including binge eating) or psychiatric disease, including 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
- Implants, devices, or foreign objects implanted in the body that interfere with the Magnetic Resonance procedures.
- Volunteers with strict dietary concerns (e.g. vegetarian or kosher diet, food allergies)
- Volunteers unwilling or unable to give informed consent
- Non-English speakers due to unavailability of required questionnaires in other languages.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Background:
Increases in obesity, diabetes, and some metabolic disorders may be linked to how much processed foods people eat. Researchers want to learn more about how processed foods affect metabolic health.
Read more
Objective:
To learn about how a processed versus unprocessed diet affects the body.
Eligibility:
Men ages 18-50 with stable weight and risk factors for diabetes
Design:
Participants will be screened over 3 visits. Screening includes:
- Medical history and physical exam
- Heart and blood tests
- Psychiatric questions
- Questions about eating, sleeping, and economic status
- Riding a stationary bike
- Trying a sample meal
Between screenings, participants will eat prepared meals. They will wear an accelerometer to measure physical activity. They will write down what foods they eat and monitor their weight.
Participants will have two 4-week stays in the clinic. They will:
- Eat a special diet
- Have activity and weight monitored
- Drink water and collect urine samples to measure how many calories they are burning
- Have resting energy expenditure measured with a clear hood over the head
- Have a scan to measure body fat and bone density using low-dose x-rays
- Have a scan on a table that slides into a metal cylinder in a strong magnetic field. They will get earplugs for the loud noises.
- Have an ultrasound test to measure blood vessels
- Have insulin and glucose infused into an arm vein. Blood will be taken over 10 hours through a plastic tube in the wrist. This will happen 4 times.
- Spend multiple 24-hour periods in a room that measures oxygen used and carbon dioxide produced.
- Give blood, urine and stool samples
- Answer questionnaires and do computer tasks
Read the detailed description
Nutrition science is beginning to place less emphasis on the nutrient composition of the diet and more emphasis on its comprising foods. A particular public health concern involves the consumption of foods that result from extensive industrial processing. Ultra-processed foods have become increasingly common and now contribute the majority of calories consumed in America. The rise in the prevalence of obesity, type 2 diabetes, and metabolic syndrome over the past several decades is believed to have been caused, in part, by the parallel increase in production, advertising, and consumption of ultra-processed foods. However, the metabolic effects of industrial processing per se, independent of diet calories or macronutrient composition, have not been carefully investigated in a controlled feeding study. Therefore, we will conduct an inpatient controlled feeding study in 20 overweight and obese adult men to investigate the changes in multi-organ insulin sensitivity and hepatic triglyceride content resulting from consuming two test diets for a pair of 3 week periods. The test diets will be implemented in a randomized, crossover design with each test diet following a 1 week run-in period of inpatient controlled feeding of a standard metabolic diet. The test diets 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. Multi-organ insulin sensitivity and hepatic triglyceride content will be measured at the end of each 1 week run-in period as well as at the end of each 3 week test diet period.
- Conditions
- Obesity
- Keywords
- Metabolism, Macronutrients, Obesity, Energy Expenditure, Glucose
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | 20 overweight and obese adult men |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine changes in hepatic insulin sensitivity following a 3-week ultra-processed diet as compared to following 3 weeks of an unprocessed diet matched for calories, macronutrient composition, sugar, fiber, and sodium.
Measured: ongoing
Secondary outcomes (1)
To determine changes in hepatic triglyceride content following a 3-week ultra-processed diet as compared to 3 weeks of an unprocessed diet matched for calories, macronutrient composition, sugar, fiber, and sodium
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2017
- Study start20 Nov 2017
- Primary completion5 Apr 2019
- Study completion5 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Kevin Hall, Ph.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03189121
- Sponsor's protocol ID
- 170107
- Other IDs
- 17-DK-0107
- Status last verified
- Apr 2019
- First submitted
- 15 Jun 2017
- Last updated
- 10 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Monteiro CA, Moubarac JC, Cannon G, Ng SW, Popkin B. Ultra-processed products are becoming dominant in the global food system. Obes Rev. 2013 Nov;14 Suppl 2:21-8. doi: 10.1111/obr.12107.
PubMed 24102801Tavares LF, Fonseca SC, Garcia Rosa ML, Yokoo EM. Relationship between ultra-processed foods and metabolic syndrome in adolescents from a Brazilian Family Doctor Program. Public Health Nutr. 2012 Jan;15(1):82-7. doi: 10.1017/S1368980011001571. Epub 2011 Jul 14.
PubMed 21752314
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Isocaloric Ultra Processed Versus Unprocessed Diets on Insulin Sensitivity
- ClinicalTrials.gov ID
- NCT03189121
- Acronym / sponsor ID
- 170107
- Conditions
- Obesity
- Keywords
- Metabolism, Macronutrients, Obesity, Energy Expenditure, Glucose
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- 5 Apr 2019 (actual)
- Study completion
- 5 Apr 2019 (actual)
- First posted
- 16 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Increases in obesity, diabetes, and some metabolic disorders may be linked to how much processed foods people eat. Researchers want to learn more about how processed foods affect metabolic health.
Objective:
To learn about how a processed versus unprocessed diet affects the body.
Eligibility:
Men ages 18-50 with stable weight and risk factors for diabetes
Design:
Participants will be screened over 3 visits. Screening includes:
- Medical history and physical exam
- Heart and blood tests
- Psychiatric questions
- Questions about eating, sleeping, and economic status
- Riding a stationary bike
- Trying a sample meal
Between screenings, participants will eat prepared meals. They will wear an accelerometer to measure physical activity. They will write down what foods they eat and monitor their weight.
Participants will have two 4-week stays in the clinic. They will:
- Eat a special diet
- Have activity and weight monitored
- Drink water and collect urine samples to measure how many calories they are burning
- Have resting energy expenditure measured with a clear hood over the head
- Have a scan to measure body fat and bone density using low-dose x-rays
- Have a scan on a table that slides into a metal cylinder in a strong magnetic field. They will get earplugs for the loud noises.
- Have an ultrasound test to measure blood vessels
- Have insulin and glucose infused into an arm vein. Blood will be taken over 10 hours through a plastic tube in the wrist. This will happen 4 times.
- Spend multiple 24-hour periods in a room that measures oxygen used and carbon dioxide produced.
- Give blood, urine and stool samples
- Answer questionnaires and do computer tasks
Detailed description
Nutrition science is beginning to place less emphasis on the nutrient composition of the diet and more emphasis on its comprising foods. A particular public health concern involves the consumption of foods that result from extensive industrial processing. Ultra-processed foods have become increasingly common and now contribute the majority of calories consumed in America. The rise in the prevalence of obesity, type 2 diabetes, and metabolic syndrome over the past several decades is believed to have been caused, in part, by the parallel increase in production, advertising, and consumption of ultra-processed foods. However, the metabolic effects of industrial processing per se, independent of diet calories or macronutrient composition, have not been carefully investigated in a controlled feeding study. Therefore, we will conduct an inpatient controlled feeding study in 20 overweight and obese adult men to investigate the changes in multi-organ insulin sensitivity and hepatic triglyceride content resulting from consuming two test diets for a pair of 3 week periods. The test diets will be implemented in a randomized, crossover design with each test diet following a 1 week run-in period of inpatient controlled feeding of a standard metabolic diet. The test diets 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. Multi-organ insulin sensitivity and hepatic triglyceride content will be measured at the end of each 1 week run-in period as well as at the end of each 3 week test diet period.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | –20 overweight and obese adult men |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 20 overweight and obese adult men.
Key inclusion criteria (9 listed)
Key exclusion criteria (12 listed)
- Evidence of metabolic or cardiovascular disease, or disease that may influence metabolism (e.g. cancer, diabetes, thyroid disease)
- Body weight >400 lbs. (weight limit of magnetic resonance spectroscopy gantry)
- 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)
- Hematocrit < 40%
- Participating in a regular exercise program (> 2h/week of vigorous activity)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To determine changes in hepatic insulin sensitivity following a 3-week ultra-processed diet as compared to following 3 weeks of an unprocessed diet matched for calories, macronutrient composition, sugar, fiber, and sodium.
Time frame: ongoing
1 secondary outcome
To determine changes in hepatic triglyceride content following a 3-week ultra-processed diet as compared to 3 weeks of an unprocessed diet matched for calories, macronutrient composition, sugar, fiber, and sodium
Time frame: ongoing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
- Background: PubMed 24102801Monteiro CA, Moubarac JC, Cannon G, Ng SW, Popkin B. Ultra-processed products are becoming dominant in the global food system. Obes Rev. 2013 Nov;14 Suppl 2:21-8. doi: 10.1111/obr.12107.
- Background: PubMed 21752314Tavares LF, Fonseca SC, Garcia Rosa ML, Yokoo EM. Relationship between ultra-processed foods and metabolic syndrome in adolescents from a Brazilian Family Doctor Program. Public Health Nutr. 2012 Jan;15(1):82-7. doi: 10.1017/S1368980011001571. Epub 2011 Jul 14.
Related trials for Obesity
Active, not recruitingPhase 2
Effects of Brain Stimulation on Food Intake and Behavioral Weight Loss Treatment
Electric Stimulation Therapy, Obesity
Not yet recruiting
High-Flow Nasal Oxygen-Assisted Deep Extubation Versus Awake Extubation in Morbidly Obese Patients
Deep Tracheal Extubation
Active, not recruiting
Adipocyte-Derived Extracellular Vesicles, Weight Loss, and Endothelial Function
Obesity, Weight Loss
Not yet recruitingPhase 2
Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
Insulin Resistance, Obesity
Not yet recruitingObservational study
A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Hall, Ph.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine changes in hepatic insulin sensitivity following a 3-week ultra-processed diet as compared to following 3 weeks of an unprocessed diet matched for calories, macronutrient composition, sugar, fiber, and sodium. (time frame: ongoing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03189121, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2019.