Neural Correlates of a Nutritionally Balanced Total Meal Replacement, 3 Week Dietary Exposure: An fMRI Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change in fMRI Food-cue Reactivity
研究概览
简要总结
In order to better understand how commonly used dietary interventions for obesity influence brain activity and in turn people's ability to adhere to their healthy nutrition plan, the investigators need to study how people's brains react to food cues while undergoing such interventions. Our study will add to our understanding of neural (brain) regulation of hedonic and homeostatic mechanisms (i.e. pleasure and hunger) in influencing adherence to calorie-reduced eating plans.
详细描述
Recruitment of subjects: Advertisements for the recruitment of participants will be posted on social media and notice boards within the Texas Tech University (TTU) including the web-based notice boards (including but not limited to Tech Announce, Craig's List). Announcements will also be made using the same materials targeting the local community through paid advertisement in local print and online media outlets (e.g. newspapers) and through flyers distributed within area medical clinics and fitness centers. Thirty-two obese (BMI > 30) male and female subjects will be enrolled with the intended completion of at least 30 (15 per group).
Pre-Screening (Telephone): Individuals who express an interest in participating will be contacted by a graduate or undergraduate research assistant who will administer a structured telephone interview to: 1) provide information related to the requirements of the study, along with potential risks and benefits 2) Screen for eligibility based on specific inclusion and exclusion criteria. All potential subjects will be informed that their responses will remain confidential and that taking part in the screening interview in no way obligates them to participate.
Potential participants who meet participation criteria as assessed via the telephone prescreening process will be contacted by the study team via email/phone within 48 hours following the interview to inform of eligibility (or ineligibility) and to schedule an initial, in person assessment (Visit 1) if deemed eligible.
Visit 1 (Screening and Consent): This in-person screening visit will include the following: Participants will be provided with the Behavioral Medicine and Translational Research (BMTR) Health & Weight History Form to complete upon arrival at the clinic. Weight, height, BMI and body fat percentage via bio-electrical impedance analysis (BIA) using the TANITA BC-418 segmental body composition analyzer (TANITA Corporation of America Inc., IL, USA) and body composition analysis unit; measured blood pressure (BP) via Omron Digital BP Monitor HEM-907XL (Omron Healthcare Inc., IL, USA) will be obtained.
If inclusion/exclusion criteria are met; informed consent will be obtained and the participant will be considered 'enrolled' in the study at that time. Participants will be scheduled for 2 scanning visits (visits 2 and 5) and the 2 check in visits (visits 3 and 4) at this time and instructed on the procedures for these subsequent visits. At completion of Visit 1 the participants will be told to make no deviation from their standard diet until after their initial fMRI scan visit (visit 2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 19-60 years
- •BMI of 30-39.9 kg/m2 (upper limit due to scanner comfort/feasibility)
排除标准
- •Participants unable to provide informed consent.
- •Participants with motor, visual or hearing impairment.
- •Females with irregular menstrual cycles.
- •Patients currently diagnosed with diabetes mellitus, experiencing uncontrolled hypertension, history of ischemic heart disease, cerebrovascular accidents, neurological disease or current severe psychiatric illness (e.g. psychosis, schizophrenia, severe untreated depression, current suicidal ideation, and current or past suicide attempts), history of psychiatric hospitalization.
- •Women who are pregnant or who are attempting to conceive.
- •Participants with contraindications for fMRI scanning.
- •aneurism clips
- •any implanted medical devices (pacemaker, neurostimulator)
- •known pregnancy
- •shrapnel in body or any injury to eye involving metal
- •any ferrous metal in body
- •Participants with a history of eating disorders such as bulimia nervosa, anorexia nervosa and severe binge eating disorder.
- •Participants with a history of substance abuse or alcohol abuse.
- •Participants who are currently on or have been on within the past 4 weeks any anti-depressant, anti-epileptic, or anxiolytic medicines.
- •Patients experiencing persistent loss of appetite, nausea or vomiting within the last 4 weeks.
- •Participants who have been involved in a weight loss intervention program (including anti-obesity medication) within the past 3 months or who have had bariatric surgery.
- •Current smokers (within the last 30 days).
研究组 & 干预措施
Total Meal Replacement
Participants will be provided instruction in the appropriate use of the meal replacement product. The participants will be directed to refrain from all items of food for a period of 21 days except for the meal replacement products and vitamin supplements provided by the investigators (1120 kcal/day). Optifast™ 800 total meal replacement shakes will be provided to the participants for the 21 day intervention period.
干预措施: Low calorie total meal replacement (Other)
Typical Diet
Participants will be directed to use portion control to maintain a calorie level no greater than 1120 kcal per day. The participants will be directed to continue to consume food and beverage items that are representative of their typical diet (with the exception of reduced portions). Participants will be provided resources to assist them in determining caloric content of foods eaten.
干预措施: Low calorie typical diet (Other)
结局指标
主要结局
Change in fMRI Food-cue Reactivity
时间窗: Baseline (pre-intervention) and 3 weeks (post-intervention)
次要结局
- Change in sub-scales of the Three-factor Eating Questionnaire(Baseline (pre-intervention) and 3 weeks (post-intervention))
- Change in sub-scales of the Food Craving Inventory(Baseline (pre-intervention) and 3 weeks (post-intervention))
- Change in Yale Food Addiction Scale(Baseline (pre-intervention) and 3 weeks (post-intervention))
- Change in Power of Food Scale(Baseline (pre-intervention) and 3 weeks (post-intervention))