Chromium Picolinate in Binge Eating Disorder: A Feasibility Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 主要终点
- binge eating frequency
研究概览
简要总结
The purpose of this study is to test the feasibility and preliminary efficacy of a 6-month chromium picolinate (CrPic) treatment trial in binge eating disorder (BED).
详细描述
Binge eating (i.e., the consumption of unusually large amounts of food with a sense of loss of control) is a common problem with serious public health implications in large part due to its role in obesity. Binge eating leads to weight gain and is common in overweight individuals. Current treatments for binge eating disorder (BED) are inadequate, and previous randomized treatment trials have suffered from high drop out rate due to the adverse effects of pharmacological agents. Chromium picolinate is a dietary supplement that has been shown to reduce symptoms of depression and appetite regulation problems in patients with atypical depression; chromium picolinate also affects insulin regulation and has been shown to improve glucose levels in patients with type-2 diabetes. This pilot study will evaluate the effect of chromium picolinate on binge eating, mood, body weight, and glucose regulation in overweight individuals with BED.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Currently meets DSM-IV criteria for binge eating disorder (BED);
- •Is able to provide informed consent and meet study visit requirements; and
- •Is psychiatrically stable (e.g., no current suicidal or homicidal intent or other psychiatric condition that requires acute intervention).
排除标准
- •Body mass index (BMI) < 24.9 kg/m^2 (underweight or normal weight) or ≥ 40 kg/m^2 (severely obese);
- •Postmenopausal;
- •Age < 18 or > 55 years;
- •Pregnant, planning on becoming pregnant during the study period, or lactating;
- •Current psychotropic medication use;
- •Current use of insulin or other medications to control glucose metabolism;
- •Current use of medications known to significantly influence appetite or weight [i.e., over-the-counter appetite suppressants that contain phentermine or sibutramine, atypical antipsychotic agents with high weight gain liability (such as olanzapine, risperidone, etc), prednisone, etc.];
- •Fasting glucose level > 126 mg/dL (indicative of diabetes); and
- •Creatinine level indicating renal insufficiency (> 1.0 for women; > 1.2 for men).
结局指标
主要结局
binge eating frequency
时间窗: baseline, 3 and 6 months, 3-month followup
次要结局
- mood(baseline, 3 adn 6 months, 3-month followup)
- insulin sensitivity(baseline, 3 adn 6 months, 3-month followup)
- body weight(baseline, 3 adn 6 months, 3-month followup)
研究者
Kimberly Brownley
Assistant Professor
University of North Carolina, Chapel Hill