Snacking Effects on the Brain Response to Foods and Satiety During Dieting
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Percent change in Blood Oxygen Level Dependent (BOLD) response to visual food cues as measured by functional magnetic resonance imaging
研究概览
简要总结
This study plans to learn more about how different types of snacks may affect brain processes relating to eating behaviors during a diet intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •25-45 years old
- •BMI at least 27 kg/m2
- •Comfortable completing a weight-loss intervention\
- •Willing to consume a daily snack of either walnuts or pretzels
排除标准
- •Nut or wheat allergy
- •History of bariatric surgery
- •Current eating disorder
- •Current illicit substance use
- •Current pregnancy, lactation (or less than 3 months after stopping lactation), or less than 6 months postpartum
- •Uncontrolled hypertension (>160/100 mmHg)
- •Significant endocrine/metabolic disease kidney disease, liver disease, or blood disease that would be anticipated to affect study results
- •Taking injectable medications, sulfonylureas, or meglitinides for diabetes treatment
- •Taking weight-loss medications, or steroids within ~3 months prior to study participation (e.g., GLP-1 receptor agonists)
- •Significant mental health changes within ~3 months prior to study participation (e.g., medication adjustments, new psychiatric diagnoses, hospitalization relating to mental health concerns)
- •Neurological illnesses or injury that would be anticipated to affect MRI data
- •Weight change greater than 10% within 3 months prior to study participation
- •Currently participating in another weight-loss study
- •Not comfortable eating the study-provided meals (with allowances for dietary preferences) and/or following a highly restrictive diet (e.g., vegan)
- •MRI-specific exclusion criteria (e.g., metal in the body, weight >500 lbs
研究组 & 干预措施
Snack Type 1: Walnuts
Participants will complete a 12 week diet intervention, during which they will be asked to reduce their daily caloric intake. During the diet intervention, participants in the Snack Type 1 group will be asked to eat a daily snack of walnuts, which will be provided by the study team. Participants will meet with study staff on a weekly basis during the intervention (with some meetings virtual and in-person visits every 2-3 weeks).
干预措施: Snack Type 1: Walnuts (Other)
Snack Type 2: Pretzels
Participants will complete a 12 week diet intervention, during which they will be asked to reduce their daily caloric intake. During the diet intervention, participants in the Snack Type 2 group will be asked to eat a daily snack of pretzels, which will be provided by the study team. Participants will meet with study staff on a weekly basis during the intervention (with some meetings virtual and in-person visits every 2-3 weeks).
干预措施: Snack Type 2: Pretzels (Other)
结局指标
主要结局
Percent change in Blood Oxygen Level Dependent (BOLD) response to visual food cues as measured by functional magnetic resonance imaging
时间窗: Baseline, 12 weeks
Percent change in blood oxygen level dependent (BOLD) response from baseline to after the 12-week intervention while viewing visual food cues will be measured using functional magnetic resonance imaging (fMRI), focusing on insula, striatum, amygdala, and prefrontal cortex.
次要结局
- Change in reward-based eating drive(Baseline, 12 weeks)
- Change in body weight(Baseline, 12 weeks)
- Change in waist circumference(Baseline, 12 weeks)
- Change in percent body fat(Baseline, 12 weeks)
- Change in appetite response to a meal(Baseline, 12 weeks)
- Change in food cravings(Baseline, 12 weeks)
- Change in dietary restraint(Baseline, 12 weeks)