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临床试验/NCT05290233
NCT05290233进行中(未招募)不适用

Time Restricted Eating Plus Exercise for Weight Management

University of Illinois at Chicago2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年9月21日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
40
试验地点
2
主要终点
Lean mass

研究概览

简要总结

Time restricted eating (TRE) is currently the most popular form of intermittent fasting which involves confining the eating window to 8-10 hours (h) and fasting for the remaining hours of the day. TRE is unique in that during the eating window, individuals are not required to count calories or monitor food intake in any way, resulting in high adherence. Accumulating evidence suggests that TRE produces a natural energy deficit of ~350-500 kcal/d. Physical activity in combination with a healthy diet pattern is recommended for older adults. While aerobic type exercise is the most commonly recommended, retention of lean mass via resistance training, especially in older adults, may be more effective at improving mobility, neurological and psychological function, executive and cognitive functioning, and processing speed. TRE combined with physical activity has not been examined in older adults or in people with overweight or obesity. This study holds the potential to 1) decrease body weight 2) improve lean mass 3) improve insulin sensitivity, and 4) improve attention, executive functioning, and processing speed in older adults. The aims of this study will examine the effect of TRE combined with either resistance training or aerobic training on body weight, body composition, metabolic disease risk, and cognition in adults over age 50. It is hypothesized that the TRE combined with resistance training group will see the most significant improvements in body composition, insulin sensitivity and cognition due to lean mass accretion.

详细描述

Time restricted eating (TRE) is currently the most popular form of intermittent fasting which involves confining the eating window to 8-10 hours (h) and fasting for the remaining hours of the day. TRE is unique in that during the eating window, individuals are not required to count calories or monitor food intake in any way, resulting in high adherence. Accumulating evidence suggests that TRE produces a natural energy deficit of ~350-500 kcal/d. Physical activity in combination with a healthy diet pattern is recommended for older adults. While aerobic type exercise is the most commonly recommended, retention of lean mass via resistance training, especially in older adults, may be more effective at improving mobility, neurological and psychological function, executive and cognitive functioning, and processing speed. T TRE combined with physical activity has not been examined in older adults or in people with overweight or obesity. This study holds the potential to 1) decrease body weight 2) improve lean mass 3) improve insulin sensitivity, and 4) improve attention, executive functioning, and processing speed in older adults. This study will examine the effect of TRE combined with either resistance training or aerobic training on body weight, body composition, metabolic disease risk, and cognition in adults over age 50. It is hypothesized that the TRE combined with resistance training group will see the most significant improvements in body composition, insulin sensitivity and cognition due to lean mass accretion.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

blood sample analysis will be blinded

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults with obesity (BMI between 30-50kg/m2)
  • pre-diabetes (fasting glucose: 100-125 mg/dl or HBA1c 5.7%-6.4% or OGTT ≥ 200 mg/dl)
  • sedentary or lightly active (<7,500 steps/day)
  • between the ages of 50-80 years

排除标准

  • diagnosed with T1DM or T2DM (fasting glucose: >126 mg/dl, 2-h glucose OGTT ≥ 200 mg/dl,
  • HbA1c: >6.5%)
  • Individuals with a history of eating disorders
  • shift workers
  • Individuals taking drugs to control body weight and glucose (including metformin)
  • individuals who are not weight stable (weight gain or loss > 4 kg) 3 months prior to the intervention
  • mobility disorders or individuals unable to exercise for 40-60 minutes 3-4 days/week
  • Individuals diagnosed with comorbidities impacting cognition, including major/mild neurocognitive disorder, cerebrovascular disease (e.g., stroke, aneurysm, arteriovenous malformation), traumatic brain injury, epilepsy, or major psychiatric disorder (e.g., schizophrenia, bipolar disorder, substance use disorder)
  • Individuals who are unable to adequately report dietary intake or physical activity

结局指标

主要结局

Lean mass

时间窗: change from week 1 to week 12

fat free mass will be measured via DXA

次要结局

  • HbA1c(change from week 1 to week 12)
  • glucose(change from week 1 to week 12)
  • processing speed(Change from week 1 to week 12)
  • body weight(change kg of body weight from week 1 to week 12)
  • fat mass(change kg of body weight from week 1 to week 12)
  • Visceral fat mass(change kg of body weight from week 1 to week 12)
  • Insulin(change from week 1 to week 12)
  • executive function(Change from week 1 to week 12)
  • Attention(Change from week 1 to week 12)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kelsey Nicole Dipman Gabel

Clinical Assistant Professor and Postdoctoral Researcher

University of Illinois at Chicago

研究点 (2)

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