Omics Profiling of the Response to Food and Variability of Weight Loss in Medically Supervised Very Low Calorie Diet
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Change in net whole-body protein synthesis
研究概览
简要总结
Understanding how foods and nutrients are digested, absorbed and metabolized when weight is stable and during weight loss induced by very low calorie diet procedure using the technologies of genomics, transcriptomics, proteomics, metabolomics and fluxomics ("omics") will enable generation of new hypotheses that could explain the inter-individual differences in weight loss and could lead to optimization and individualization of therapies designed to lose weight.
详细描述
The overarching hypothesis is that there are baseline, pre- and post-diet combinations of 'omics' signatures in response to food and nutrients that explain the weight loss response of obese subjects to the very low calorie (VLC) diet.
In order to address the general hypothesis the following specific aims will be addressed:
Specific Aim 1: To test the hypothesis that there is a combination of 'omics' parameters in response to a defined meal that discriminate between morbidly obese subjects.
Specific Aim 2: To test the hypothesis that variation in % weight loss to the 2-weeks of VLC diet is related to baseline genomic markers, gene expression profile, proteomic and metabolomic signatures as well as baseline metabolic and substrates fluxomics response to a defined meal.
Specific Aim 3: To test the hypothesis that variation in % weight loss to the 4-weeks of VLC diet is related to baseline genomic markers, gene expression profile, proteomic and metabolomic signatures as well as baseline metabolic and substrates fluxomics response to a defined meal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •obese subjects:
- •Diagnosed with morbid obesity (defined as BMI > 40 kg/m2 or BMI > 35 kg/m2 with at least one serious comorbidity (2013 NIH compendium guidelines)) Scheduled for medically supervised Very Low Calorie Diet Age 30 years and older Ability to lay in supine or elevated position for 5 hours Willingness and ability to comply with the protocol
排除标准
- •Any condition that may interfere with the definition 'healthy subject' according to the investigator's judgment (for healthy control group only) Participation in Weight Loss Management Program within the last 6 months prior the first study day Presence of fever within the last 3 days Untreated metabolic diseases including hepatic or renal disorder unrelated to the primary disease Presence of acute illness or metabolically unstable chronic illness unrelated to the primary disease
- •· (Possible) pregnancy Any other condition according to the PI or nurse that would interfere with the study or safety of the patient Failure to give informed consent Use of protein or amino acid containing nutritional supplements within 3 days of first test day
研究组 & 干预措施
obese
screening visit: body weight and composition by DXA, height, and vital signs will be assessed. Subjects may sign a medical release form to obtain medical and psychological information about them that will help determine study eligibility or can be used for later coding.
3 study days (one baseline, one approx 2 weeks of diet, one post-diet): muscle mass and function tests, resting energy expenditure, stable isotope infusions with blood draws, and questionnaires regarding quality of life, mood and depression, diet.
干预措施: Stable isotope amino acid infusion (Other)
结局指标
主要结局
Change in net whole-body protein synthesis
时间窗: 0, 2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 225, 240, 260, 280, 300, 320, 340, 360 ± 5 min
Change in whole-body protein synthesis rate after intake of meal
次要结局
- Group differences in activity as measured by Physical Activity Scale for the Elderly (PASE)(Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3)
- Group differences in attention and executive functions as measured by Stroop Color-Word Test (SCWT)(Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3)
- Group differences in state of mood as measured by the Profile of Mood State (POMS)(Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3)
- Group differences in state of mood as measured by the Hospital Anxiety and Depression Scale (HADS)(Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3)
- Group differences in learning and memory as measured by Auditory Verbal Learning Test (AVLT)(Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3)
- Executive Function-Adolescent/Adult Sensory Profile (ASP)(Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3)
- Group differences in quality of life as measured by Short Form (36) Health Survey (SF36)(Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3)
- Group differences in learning and memory as measured by Controlled Oral Word Association Test (COWAT)(Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3)
- Group differences in attention and executive functions as measured by PASAT(Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3)
- Group differences in attention and executive functions as measured by Trail Making Test (TMT)(Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3)
- Skeletal muscle strength(on study day 1 and the change from day 2 and day 3)
- 24 hour diet recall(on study day 1 and the change from day 2 and day 3)
- Respiratory muscle strength(on study day 1 and the change from day 2 and day 3)
- Body Composition(on study day 1 and the change from day 2 and day 3)
- Group differences in overall cognitive abilities as measured by Montreal Cognitive Assessment (MoCA)(Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3)
- Group differences in attention and executive functions as measured by Brief-A(Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3)
- Gut function(postabsorptive and prandial state every 20 minutes up to 6 hours before each sip feeding on day 1 and the change from day 2 and day 3)
研究者
Marielle PKJ Engelen, PhD
Associate Professor
Texas A&M University