Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 17-DK-0107 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Volunteers | 20 overweight and obese adult men |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
Not provided
Not provided
20 overweight and obese adult men.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kevin Hall, Ph.D. | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24102801 | Background | 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. | |
| 21752314 | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |