GLP-1 Analogue Effects on Food Cues, Stress, Motivation for Highly Palatable Foods, and Weight
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Change in Craving Score
研究概览
简要总结
To examine response to a glucagon-like peptide-1 analogue vs. placebo in patients with obesity and assess impact on craving, hunger, stress, and weight outcomes.
详细描述
A randomized, double-blind, placebo-controlled 12-week study with GLP-1 analogue (semaglutide) in men and women with obesity (BMI 30-49.9 kg/m2) in a validated laboratory model to identifying processes underlying greater food craving, intake and weight change, in order to test mechanisms by which a GLP-1 analogues may exerts significant weight effects in obesity.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI ranging from 30-49.9 kg/m2
- •No significant medical problems, including diabetes
- •No history of HgbA1c <6.5%
- •English speaking and able to read English and complete study evaluations
- •Able to provide informed written and verbal consent
排除标准
- •Any significant current medical conditions, including neurological, renal, thyroid, cardiovascular, liver, endocrine or immune conditions, including diagnosis of T2DM or T1DM by American Diabetes Association (ADA) criteria
- •Meet current or past DSM-IVR criteria for alcohol dependence or any substance use disorders, including nicotine, or psychiatric disorders, including eating disorders, or use of any psychiatric medications, including anxiolytics, antidepressants, naltrexone or antabuse, anti-smoking medications
- •Current active participation in a weight loss program or weight loss of >10% of total body weight during the prior 6 months
- •Taking any other anti-obesity medication
- •History of pancreatitis, medullary thyroid cancer, or MEN syndrome, or (6) women who are pregnant or lactating, or peri/postmenopausal
研究组 & 干预措施
GLP-1a
GLP-1a Semaglutide target dose of 1.2 mg administered weekly over 12 weeks
干预措施: GLP-1 analogue - semaglutide (Drug)
Placebo
Placebo pen administered weekly over 12 weeks
干预措施: Placebo (Other)
结局指标
主要结局
Change in Craving Score
时间窗: Average change in avg FCI craving score from week 0 to end of treatment (week 12) computed as avg FCI score at week 12 - avg FCI score at Week 0.
Change in craving score will be measured using a validated and revised questionnaire called Food Craving Inventory (FCI-R). FCI-R is an 28-item questionnaire that measures how often participants experienced specific food cravings for each of 28 different food types. Participants can respond to each item from "not at all" (score=1) to "more than ever" (score=5), with total FCI-R score range of 28-140. Higher mean scores indicate greater average food craving. A negative change indicates a decrease in craving with treatment.
Change in Hunger Score
时间窗: Average change in hunger VAS rating from week 0 and end of study week 12 (week 12 VAS - Week 0 VAS)
Hunger will be measured in a Visual Analog Scale (VAS) range from 0 to 10. Higher VAS indicates greater hunger. Negative change in score indicates less hunger with treatment.
Change in Food Intake
时间窗: Change in FST total calorie energy density (totalcalED)from FST at week 0 and FST during treatment at week 12 (week 12 FST - Week 0 FST totalcalED change)
Food intake will be measured in total calorie energy density during a validated observed laboratory task called the Food Snack Test (FST).Negative change indicates a lower food intake with treatment.
次要结局
- Change in Food Intake - Real-World(Average change from baseline to end of treatment (Kcalories at week 12 - week 0))
- Change in Stress Score(Average change in stress score from week 0 to end of treatment week 12 (Week 12 - Week 0))