Randomized Controlled Trial Examining the Effects of Meal Timing Among Obese Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Body Mass (Weight)
研究概览
简要总结
The randomized, cross-over design study is designed to determine how timing of eating affects weight, adiposity, energy metabolism, and gene expression. Obese participants will be provided isocaloric meals and snacks to be consumed in one of two prescribed eating conditions -- daytime eating and delayed eating.
详细描述
The study consists of the following phases - screening, assessment visit 1, eating condition 1, assessment visit 2, a wash-out period, assessment visit 3, eating condition 2 and assessment visit 4, as discussed in detail below. The assessment visits will all consist of the same procedures and will take place at the Center for Human Phenomic Science (CHPS) of the Hospital of the University of Pennsylvania before and after each of the eating conditions (four times total). The four 28-hour inpatient assessments will consist of blood draws, adipose (fat) tissue sampling, a dual energy X-ray absorptiometry (DEXA) scan, and a resting metabolic rate test.
During the screening period in order to determine eligibility, participants must complete a 2-part screening visit; This includes:
- A complete physical examination
- Tests of blood to screen for any conditions such as diabetes or any serious, uncontrolled medical condition that may interfere with participation in the study.
- An Electrocardiogram (EKG) test
- Urine Pregnancy Test
- Urine Drug Screening
- the completion of several self-report questionnaires and structured interviews
During the screening period, participants will also be asked to keep a 10-day food log where they will record all food and beverages consumed and their sleep and exercise schedule. Participants will be asked to wear an Actigraph wrist watch at this time.
Following successful completion of the screening period, participants will complete the first of 4 assessment visits. All assessment visits will follow the same protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 21-50
- •BMI of 30-50 kg/m2
- •stable weight (±10 lb) over the previous 6 months
- •women must be pre-menopausal with regular menstrual cycles
排除标准
- •unstable, serious medical conditions
- •use of medicine linked to weight gain/loss
- •cardiac conditions
- •autoimmune disease
- •use of illicit drugs, melatonin, diuretics or hypnotics
- •involved in a current weight loss program
- •presence of an untreated sleep disorder (determined by surveys and actigraphy)
- •those who work shift work
- •those with extreme chronotypes
- •habitual waking outside of 0600h-0930h
- •habitual bedtime <2200h or >2400h
- •sleep duration of <6.5 or >8.5 h/night.
- •psychiatric exclusions will be: depression (Patient Health Questionnaire-9 score ≥9), lifetime bipolar disorder, psychosis, or eating disorder; or any other severe psychiatric disorder judged to interfere with study adherence as assessed by the MINI International Neuropsychiatric Interview.
- •structured exercise >3 d/wk, for >30 min measured by exercise logs and actigraphy; normal activity levels are required during the study (±30 min/wk of baseline level).
结局指标
主要结局
Body Mass (Weight)
时间窗: pre-post changes between the daytime and delayed eating conditions (each 8 weeks long)
changes in body mass, as measured by a calibrated digital scale, will be explored.
Adiposity - Total Body Fat
时间窗: pre-post changes between the daytime and delayed eating conditions (8 weeks).
changes in measures of total body fat, as measured by a DEXA scan, will be explored.
Energy Homeostasis Outcomes - REE
时间窗: pre-post changes between the daytime and delayed eating conditions (8 weeks).
Changes in resting energy expenditure values will be explored.
Energy Homeostasis - Respiratory Quotient
时间窗: pre-post changes between the daytime and delayed eating conditions (8 weeks).
Respiratory quotient (RQ) was measured with a Parvo-Medics metabolic cart. It is calculated from the ratio of carbon dioxide produced by the body to oxygen consumed by the body, when the body is in a steady state.
次要结局
未报告次要终点
研究者
Kelly Allison
Director, Center for Weight and Eating Disorders
University of Pennsylvania