Assessing the Feasibility and Acceptability of a Time Restricted Feeding Intervention Among Older Adults With Mild Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Change in Memory Composite Rank
研究概览
简要总结
Obesity and related metabolic comorbidities have been associated with more than a 4-fold increased risk of incident cognitive impairment, including Alzheimer's disease and related dementias (ADRD). Dysfunctional metabolic flexibility is increasingly recognized as a critical mechanism linking metabolic risk factors to risk of cognitive impairment, although few studies portable behavioral strategies to enhance metabolic function among individuals at risk for ADRD. The present study will examine the feasibility and acceptability of a 12-week time restricted feeding intervention among individuals with mild cognitive impairment (MCI). Changes in cognitive and metabolic function will also be examined.
详细描述
Obese older adults with mild cognitive impairment with mild cognitive impairment will be asked to participate in a 12 week time restricted fasting intervention. Working with a behavioral psychologist, they will adapt the timing their eating patterns to incorporate 2-3 days per week with a 16 hour fasting period, typically lasting from after dinner to lunch the next day. The behavioral intervention will titrate fasting using established behavioral change techniques, with early phase sessions focusing on organizational principles to prepare for weekly fasting scheduling and acceptance-based psychological coping skills, including the ability to tolerate symptoms of hunger and discomfort that may accompany fasting. After treatment initiation, sessions will focus on broadening fasting behaviors for flexible adoption across different contexts and to enhance maintenance of fasting patterns. At baseline and following treatment, participants will undergo tests of cognitive and metabolic function to assess memory, executive function, metabolic flexibility, and inflammation. At both time points, participants will also undergo an abbreviated assessment of cognitive and metabolic function under fasting conditions to assess for any cognitive weaknesses unmasked during periods of brief metabolic 'stress'.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Assessors will be blinded to the participant's intervention fidelity and engagement.
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects will include those men and women:
- •aged 65-80 years,
- •with amnestic Mild Cognitive Impairment (Montreal Cognitive Assessment Battery score [MoCA] total score 19-25 or a phonemic fluency score of =<12 (with MoCA >25) or semantic fluency score of =<15 (with MoCA >15); and score of > 1.0 on the Mail-in Cognitive Function Screening Instrument),
- •obese (body mass index 27.5-40 kg/m^2),
- •sedentary, and
- •willing to participate in all aspects of the proposed intervention.
排除标准
- •Reasons for participant exclusion will include:
- •secondary causes of obesity,
- •evidence of clinical dementia (MoCA score < 18), severe chronic kidney disease (eGFR <45 ml/min/1.73m^2),
- •heart failure,
- •high grade arrhythmias,
- •severe valvular heart disease,
- •severe asthma or chronic obstructive lung disease,
- •diabetes requiring insulin,
- •musculoskeletal or neurologic problems that would preclude participation in aerobic exercise training,
- •a major psychiatric disorder,
- •a history of drug abuse,
- •alcohol consumption >14 drinks/week,
- •gastric bypass surgery,
- •non-English speaking, or
- •a life-limiting comorbid medical condition (e.g. cancer).
研究组 & 干预措施
Time restricted eating
Participants will engage in a 12-week time restricted fasting intervention. Each week, participants will work with a clinical psychologist to modify the timing of their eating behaviors to adhere to a 16-hour fast, 2-3 days per week.
干预措施: Time restricted eating (Behavioral)
结局指标
主要结局
Change in Memory Composite Rank
时间窗: Baseline, 12 Weeks
Participants completed two assessments of learning and memory at each time point. The Hopkins Verbal Learning Test Revised (HVLT-R) was used to assess verbal memory and the Brief Visual Memory Test - Revised (BVMT-R) was used to assess visual memory. Both the HVLT-R and the BVMT-R provide three separate scores that reflect total learning, retention of information, and recognition of learned items following a delay. In order to create a single Memory performance score, each of these six scores were ranked at each time point and a mean rank was created, with higher scores reflecting higher Memory performance. The mean rank for Memory performance at 12 weeks was used as the outcome, controlling for baseline Memory performance. Larger mean ranks at 12 weeks indicate greater improvements. As a rank-based outcome, values have no fixed theoretical upper or lower bound.
Change in Executive Function Composite Rank
时间窗: Baseline, 12 Weeks
Participants underwent multiple assessments of Executive Functioning at each time point. Specifically, participants completed the Trail Making Test Parts A \& B, the Digit Span Forwards and Backwards Tasks, the Digit Symbol Substitution Test, the Controlled Oral Word Association Test, the Animal Naming Test, and the Stroop Word and Color-Word Interference Tests at both pre-and-post treatment. In order to create a single Executive Function score, each of these nine measures were ranked at each time point and a mean rank was created, with higher scores reflecting higher Executive Function performance. The mean rank for Executive Function performance at 12 weeks was used as the outcome, controlling for baseline Executive Function performance, with larger 12-week mean ranks indicating greater improvements compared to baseline. As a rank-based outcome, values have no fixed theoretical upper or lower bound.
次要结局
- Change in Metabolic Function Composite Rank(Baseline, 12 Weeks)
- Change in Inflammatory Function Composite Rank(Baseline, 12 Weeks)