Eating, Gliosis, Obesity
Conditions
Brief summary
The purpose of this study is to use magnetic resonance imaging (MRI) to evaluate the human hypothalamus for signs of inflammation in response to specific diets. This research may lead to a better understanding of how poor nutritional quality may lead to obesity through effects on regions of the brain known to regulate body weight.
Interventions
OTHERDiet modification #1
Participants will be provided all meals for a 14-day period. For 7 of the days, meals will be 130% of estimated daily caloric needs and for the other 7 days, meals will be low in calories, consistent with recommendations for weight loss.
OTHERDiet modification #2
Participants will be provided all meals for a 14-day period. For 7 of the days, meals will be 150% of estimated daily caloric needs and for the other 7 days, meals will be meals will be low in calories, consistent with recommendations for weight loss.
OTHERDiet modification #3
Participants will be provided all meals for a 14-day period to be approximately 100% of estimated daily caloric needs.
Sponsors
University of Washington
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 20-40 years * Overweight: BMI 25-29.9 kg/m2 * Willing to undergo randomly assigned 14-day diet modification
Exclusion criteria
* History of bariatric surgery or active participation in weight-loss program * Major medical or neurological disorder (e.g., diabetes, multiple sclerosis) * Anemia or impaired kidney or liver function * Known gallbladder disease or gallstones * Hypertriglyceridemia (\>350 mg/dl) * Current use of orlistat or other weight-loss medications or other medications known to alter appetite (e.g., atypical anti-psychotics) * More than moderate level of physical activity (\>1000 met-min/wk) * Pregnancy, menopause, or breastfeeding * MRI contraindication (e.g., implanted metal, claustrophobia) * Lifetime eating disorder * Current smoking or heavy alcohol use (≥ 2 drinks per day for females and ≥ 3 drinks per day for males) * Weight \> 350 pounds (MRI limit) * Dietary restrictions (e.g., vegan) incompatible with controlled diets
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hypothalamic Gliosis | 7 days of diet intervention | T2 relaxation time as measured by brain MRI |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOREllen A Schur, MD, MS
University of Washington
Participant flow
Pre-assignment details
N=2 were enrolled, but became ineligible at or following the first study visit.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 30.0 year STANDARD_DEVIATION 4.9 |
| BMI | 26.5 kg/m2 STANDARD_DEVIATION 1.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 10 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 10 | 0 / 11 |
| other Total, other adverse events | 0 / 13 | 0 / 10 | 0 / 11 |
| serious Total, serious adverse events | 0 / 13 | 0 / 10 | 0 / 11 |
Outcome results
None listed