Prolonged Daily Fasting as a Viable Alternative to Caloric Restriction in At-Risk Obese Humans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Change in Weight
研究概览
简要总结
Purpose: Obesity is reaching epidemic proportions, affecting 36% of the adult population in the United States. There is intense interest in dietary management to treat obesity and its associated complications. The first line of obesity treatment is caloric restriction (CR), although recidivism is common. For moderate CR, attrition rates of 20% are often reported, therefore weight loss options beyond CR are urgently needed.
详细描述
Aim#1: Evaluate the effect of TRE with ad libitum intake on weight and body composition.
H 1.1: Individuals in the TRE and CR groups will have similar weight loss, which will be greater than weight loss achieved in the non-TRE group (primary outcome).
H 1.2: TRE will result in greater loss of loss of total body fat (quantified by DXA) and greater loss of hepatic/visceral fat/ectopic fat (quantified by MRI) than CR.
Aim#2: Assess the effect of TRE with ad libitum intake on caloric balance. H 2.1: TRE will reduce caloric intake compared with non-TRE [gold-standard interviewer administered 24-hour dietary recall (primary outcome)] with similar reduction as with CR, H.2.2: Compared with non-TRE, TRE will result in selection of more nutrient dense foods during a supervised meal within their eating window; this selection will be similar to CR. H 2.3 TRE will not alter physical activity, but will increase fat oxidation compared with CR and non-TRE.
Aim#3: Assess the effect of TRE with ad libitum intake on metabolic flexibility.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI ≥30 and ≤ 55 kg/m^2
- •Own a smartphone compatible with the myCircadianClock (mCC) phone application
- •Self-reported habitual wakening between 5-9 am
- •Self reported sleep duration of 6-9 hours
- •Weight must be stable [+/- 5 pounds] for at least 3 months prior to the study
- •Eating window (time between 1st food intake and last food take) ≥14 hours using mCC
- •Insulin resistance based on HOMA-IR≥ 2.5 from screening visit results
- •Able to understand English
排除标准
- •Use of beta-blockers or medications known to affect weight, such as thiazolidinedione (TZD), insulin, glucagon-like peptide (GLP)-1 agonists, phentermine, or sibutamine
- •Shift work (i.e. working from 11pm to 7am)
- •Clinically significant medical issues (diabetes, cardiovascular disease, uncontrolled pulmonary disease)
- •A history of abnormal laboratory results, such as hematologic (platelets < 100), hepatic (LFTs > 2X nl), renal (Cr > 1.5)
- •MRI contraindication (metal in body, claustrophobia)
- •Eating window < 12 hours per day
- •Unable to consistently document food intake using the mCC app (need at least 2 eating occasions> 6 hours apart on a given day for at least 50% of days)
- •Pregnancy
- •Illiteracy
- •Concern for active eating disorder per screening questionnaire
- •Self-reported eating disorder or history of eating disorder
研究组 & 干预措施
Time Restricted Eating (TRE)
For the TRE group, we will restrict the eating window to 8 hours, where they will eat ad libitum. This is the same interval established by Dr. Panda and by our preliminary data. This interval will be entered into the mCC app and participants will be asked to adhere to this eating window during the intervention. All eating occasions will be logged using the mCC app. Only water and medications will be allowed outside of the eating window.
干预措施: Time Restricted Eating (TRE) (Behavioral)
Caloric Restriction (CR)
Participants randomized to CR will meet with the study dietitian prior to the intervention and be counseled on options to reduce their caloric intake by 15%, while maintaining their eating window. The 15% reduction was selected as our preliminary data and recent literature suggest that TRE with ad libitum intake reduces caloric intake by ~270 to 300 cal/day. The 15% CR is similar to the 11.9% CR achieved by the CALERIE-2 study, which is a 2 year study of CR.26 All eating occasions will be logged using the mCC app. The weekly dietitian review of the mCC information will include maintenance of the eating window and examination of dietary intake to determine compliance with the 15% CR.
干预措施: Caloric Restriction (CR) (Behavioral)
Unrestricted Eating (non-TRE)
For the unrestricted eating (non-TRE) group, participants will eat ad libitum per their usual habits. They will receive initial counseling about mCC logging. All eating occasions will be logged using the mCC app.
结局指标
主要结局
Change in Weight
时间窗: 12 weeks
Weight will be measured by standard scale and reported in kilograms. This between 2 time points - baseline and 12 weeks
次要结局
- Change in Whole Body Percent Fat(Baseline, 12 weeks)
- Change in Visceral Fat(Baseline, 12 weeks)
- Change in Lean Mass(Baseline, 12 weeks)
- Change in Fat Mass(Baseline, 12 weeks)
- Change in Caloric Intake(Baseline, 12 weeks)
- Change in Metabolic Flexibility(baseline, 12 weeks)