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Effect of Isocaloric Ultra Processed Versus Unprocessed Diets on Insulin Sensitivity

This study is currently recruiting participants.
Verified October 13, 2017 by National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )
Sponsor:
ClinicalTrials.gov Identifier:
NCT03189121
First Posted: June 16, 2017
Last Update Posted: December 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )
  Purpose

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

Condition
Obesity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Effect of Isocaloric Ultra Processed Versus Unprocessed Diets on Insulin Sensitivity

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
Actual Study Start Date: November 20, 2017
Estimated Study Completion Date: February 28, 2020
Estimated Primary Completion Date: February 28, 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts
Healthy Volunteers
20 overweight and obese adult men

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 becoming 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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
20 overweight and obese adult men
Criteria
  • INCLUSION CRITERIA:

    1. Adult men, age 18-50 years
    2. Weight stable (< plus or minus 5 % over past 6 months)
    3. Current stable weight no more than 8% below lifetime maximum weight
    1. Body mass index (BMI) greater than or equal to 25 kg/m^2
    2. Plasma triglycerides > 150 mg/dl (Caucasian) or >140 mg/dl (African American)
    3. Homeostatic model of insulin resistance (HOMA-IR) > 2
    4. Able to complete daily bouts of stationary cycling at a moderate rate and intensity with a HR greater than 0.3(SqrRoot) (220-age-HRrest)+HRrest but not exceeding 0.6(SqrRoot) (220-age- HRrest)+HRrest and no signs of arrhythmia
    5. Written informed consent
    6. Willing to eat all the food provided in the study
    7. Willing to continue consistently their habitual caffeine intake

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 < 40%
  4. Participating in a regular exercise program (> 2h/week of vigorous activity)
  5. Caffeine consumption > 300 mg/day
  6. Regular use of alcohol (> 2 drinks per day), tobacco (smoking or chewing) amphetamines, cocaine, heroin, or marijuana over past 6 months
  7. 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
  8. Implants, devices, or foreign objects implanted in the body that interfere with the Magnetic Resonance procedures.
  9. Volunteers with strict dietary concerns (e.g. vegetarian or kosher diet, food allergies)
  10. Volunteers unwilling or unable to give informed consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03189121


Contacts
Contact: Kevin Hall, Ph.D. (301) 402-8248 kevinh@helix.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
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)
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT03189121     History of Changes
Other Study ID Numbers: 170107
17-DK-0107
First Submitted: June 15, 2017
First Posted: June 16, 2017
Last Update Posted: December 4, 2017
Last Verified: October 13, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ):
Metabolism
Macronutrients
Obesity
Energy Expenditure
Glucose

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs