NCT05626907已完成不适用
Assessing the Effect of Diet on Hypothalamic Gliosis in Humans
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Hypothalamic Gliosis
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 20-40 years
- •Overweight: BMI 25-29.9 kg/m2
- •Willing to undergo randomly assigned 14-day diet modification
排除标准
- •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
研究组 & 干预措施
Assigned Diet #2
Experimental
干预措施: Diet modification #2 (Other)
Assigned Diet #3
Other
干预措施: Diet modification #3 (Other)
Assigned Diet #1
Experimental
干预措施: Diet modification #1 (Other)
结局指标
主要结局
Hypothalamic Gliosis
时间窗: 7 days of diet intervention
T2 relaxation time as measured by brain MRI
次要结局
未报告次要终点
研究者
Ellen Schur, MD, MS
Professor, School of Medicine
University of Washington
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Hypothalamic Functional Magnetic Resonance Imaging (fMRI) Response to NutrientsObesityNCT00686608Oregon Health and Science University56
Unknown
不适用
Exploration by UHF MRI of Hypothalamic Networks Associated to Feeding in Obesity and AnorexiaEating DisordersNCT04451759Assistance Publique Hopitaux De Marseille66
已完成
不适用
High Energy Phosphate Metabolites in BrainHealthyNCT03101345Société des Produits Nestlé (SPN)25
已完成
不适用
MRI Based Study to Assess Brain-gut Axis in ObesityObesityNCT05437653University of Nottingham24
已完成
不适用
Impact of Hypothalamic Gliosis on Appetite Regulation and Obesity Risk in ChildrenObesity, ChildhoodNCT04260048University of Washington101