Effect of Isocaloric Ultra Processed Versus Unprocessed Diets on Insulin Sensitivity

NCT03189121 | Completed

• 2 other identifiers: 17010717-DK-0107
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Obesity

Keywords

Metabolism; Macronutrients; Obesity; Energy Expenditure; Glucose

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  ongoing

Study Arms (1)

Healthy Volunteers

20 overweight and obese adult men

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

20 overweight and obese adult men.

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

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

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (2)

• 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.

  PMID: 24102801 BACKGROUND

• Tavares 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.

  PMID: 21752314 BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kevin Hall, Ph.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2017
• First Posted: June 16, 2017
• Study Start: November 20, 2017
• Primary Completion: April 5, 2019
• Study Completion: April 5, 2019
• Last Updated: April 10, 2019

Record last verified: 2019-04

Locations

US (1)