Pilot Study of Isocaloric Time Restricted Eating on Ketone Metabolism and Immunoregulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Change in CD4+ T cell responsiveness (Th17 polarization)
研究概览
简要总结
Background:
Time restricted eating (TRE) is a form of fasting in which a person eats only during a set window of time, which is usually between 4 and 10 hours each day. Researchers want to know more about how TRE may affect health.
Objective:
To learn how TRE affects women with different body sizes.
Eligibility:
Healthy women aged 18 to 50 years.
Design:
Participants will have 2 visits: 1 screening visit and one 5-day stay in the clinic.
Participants will fast before both visits. They will have a physical exam with blood tests. They will talk to a nutritionist about the foods they eat. They will lay under a clear hood for up to 45 minutes during a test that measures how many calories they burn while resting.
Participants will keep a food diary for up to 7 days before their clinic stay. They will apply a continuous glucose monitor the day before they go to the clinic. This is a device that attaches to the skin of the stomach. They will wear this device throughout their clinic stay.
All meals will be provided during the clinic stay. Participants will follow TRE on 3 days. They will answer survey questions and have tests during their stay, including:
- DXA (dual energy X-ray absorptiometry) scan. Participants will lie on a padded table. Their body will be scanned to measure how much muscle, bone, fat, and other tissues they have.
- Stable isotope tracer study. Small amounts of sugar and other substances will be given through a tube attached to a needle inserted into a vein in the arm. Blood samples will be collected.
详细描述
Study Description:
Intermittent fasting confers anti-inflammatory effects, although underlying metabolic mechanisms are poorly defined. This pilot study will explore ketone bodies as a mediator of inflammation in response to time restricted eating (TRE-6-hr feeding/18-hr fast) without caloric restriction compared to a more conventional dietary regimen (12-hr feeding/12-hr fast) in women classified as obese and lean.
Objectives:
Primary Aim 1: Quantify ketone body (beta-OHB) whole-body turnover after short-term early 6-hr TRE compared to a conventional 12-hr dietary regimen in women.
Primary Aim 2: Quantify CD4+ T cell responses after short-term early 6-hr TRE compared to a conventional 12-hr dietary regimen in women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •* INCLUSION CRITERIA:
- •In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- •1. Stated willingness to comply with all study procedures and availability for the duration of the study
- •2. Women between ages 18-50 years who are premenopausal (defined as regular menses and/or FSH \=30 kg/m\^2
- •4. In good general health as evidenced by medical history and/or screening laboratory evaluation.
- •5. Agreement to adhere to Lifestyle Considerations throughout study duration
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Diagnosis/treatment for immune/inflammatory disorder or other metabolic conditions that would interfere with study parameters, including diabetes, chronic kidney, chronic liver disease, history of hypoglycemia, and thyroid disease (with the exception of chronic controlled hypothyroidism as measured by TSH within normal limits)
- •Current use of antihyperglycemic medications, systemic steroids, adrenergic-stimulating agents, or medications affecting sleep, circadian rhythms, or metabolism which affect parameters under investigation (examples include oral contraceptives, anti-diabetic agents, nicotinamide riboside, tryptophan, vitamin B3 supplements)
- •Caffeine consumption in excess of approximately 300 mg (approximately three 8-oz cups of coffee) daily
- •Factors that affect circadian rhythms including individuals who perform overnight shift work, report irregular sleep and/or eating schedules, and who regularly fast for more than 15 hours/day
- •History of an eating disorder by self-report or medical history
- •Food allergies/intolerances or dietary patterns that would prohibit consumption of metabolic diet
- •Inability to provide informed consent
- •Pregnancy or lactation
- •Unstable weight with more than 5% body weight change in last previous 3 months
- •Engaged in competitive sports training and/ or unwilling to comply with exercise regimen in this protocol.
- •Consumption of more than 3 servings of alcohol daily
- •Current smoker or regular tobacco use, vaping, or other forms of nicotine within prior 3 months
- •This study will recruit only women. The study design was informed by our Protocol NCT04728165 which investigates an identical 6:18h TRE intervention in males who are healthy and those with psoriasis. Based on our pilot data in men, the current study is needed to test our hypothesis in women. This study in women is a critical next step to replicate the findings in women and to understand sex-specific differences in TRE response and ketone metabolism.
研究组 & 干预措施
Premenopausal women (lean and obese)
Ages 18-50 yearsBMI 18.0-24.5 mg/k^2 or BMI > 30 mg/k^2
干预措施: Early Time-Restricted Eating (Behavioral)
Premenopausal women (lean and obese)
Ages 18-50 yearsBMI 18.0-24.5 mg/k^2 or BMI > 30 mg/k^2
干预措施: Conventional dietary regimen (12-hr, 9:30a-9:30p) (Behavioral)
结局指标
主要结局
Change in CD4+ T cell responsiveness (Th17 polarization)
时间窗: Day 0, Day 3
Within subject difference in CD4+ T cell response after 3 days of 6-hr TRE compared to a 12-hr eating window regimen
Change in ketone body (beta hydroxybutyrate) rate of appearance (Ra)
时间窗: Day 0, Day 3
Within subject difference in ketone body (beta hydroxybutyrate) rate of appearance (Ra) after 3 days of 6-hr TRE compared to a 12-hr eating window regimen
次要结局
- Change in post-absorptive glucose rate of appearance (Ra)(Day 0, Day 3)
- Change in ketone body rate of appearance (Ra) in lean women vs women with obesity(Day 0, Day 3)
- Change in CD4+ T cell responsiveness (Th17 polarization) in lean women vs women with obesity(Day 0, Day 3)
- Ketone biology in isolated CD4+ T cells(Day 0, Day 3)