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临床试验/NCT03525717
NCT03525717已完成不适用

The Effect of Routine vs Late Dinner on Nocturnal Metabolism and Fat Oxidation

Johns Hopkins University2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2018年5月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
2
主要终点
Free Fatty Acids (FFA, mmol/L)

研究概览

简要总结

This study examines the impact of routine dinner time versus late dinner time on nocturnal metabolism. Specifically, investigators will examine plasma profiles of free fatty acids, glucose, insulin, triglycerides, and oxidation of dietary fat.

详细描述

Obesity is an epidemic contributing to significant global morbidity and mortality. More than simply being a manifestation of excessive eating, obesity and metabolic syndrome may also be the consequence of inappropriate timing of food intake. Specifically, eating more calories later in the day contributes to greater weight gain and metabolic syndrome. The mechanism by which later eating harms metabolism is not fully understood. Meal digestion, absorption, and oxidation can be influenced by circadian rhythm and sleep/wake status. Sleep induces a regulated decrease in metabolic rate, which would be expected to impair the oxidation of ingested fat.

Investigators hypothesize that eating dinner at 10 PM, close to sleep time (11 PM), compared to usual time (6 PM) will lead to impaired nocturnal metabolic profile and reduced fatty acid oxidation of ingested fat. Investigators will test this hypothesis in a randomized crossover study comparing routine dinner (RD) to late dinner (LD) on the nocturnal metabolic profile, and assess oxidation of ingested fat using a stable isotope tracer. If investigators can demonstrate that nocturnal metabolic profile and oxidation of exogenous fat is affected by timing of dinner, investigators can target these pathways for combating obesity and related metabolic consequences.

Study Procedures:

Investigators will perform a randomized cross-over study of RD versus LD on overnight metabolic function in healthy volunteers. Subjects will report to the Bayview Asthma and Allergy center for screening and consent. If participants provide written informed consent, participants will undergo a history and physical examination. Each participant will come to the Clinical Research Unit (CRU) for 2 visits (RD or LD), each comprised of 2 consecutive nights (acclimation night, then study night). The RD and LD visit will be spaced about 3-4 weeks apart, and occur in random order to allow washout of effects and tracer. To account for potential metabolic effects of menstrual cycles, women will studied at the same phase of their menstrual cycle (visits will be ~4 weeks apart). Participants will not have any routine care or current therapy discontinued to enroll in the study.

General visit schedule:

研究设计

研究类型
Interventional
分配方式
Randomized
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 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy male and female adult volunteers, age 18-
  • Accustomed to a bedtime between 10:00 PM and 1:00 AM.

排除标准

  • Sleep disorder including insomnia, sleep apnea, circadian rhythm disorder, restless leg syndrome, narcolepsy, shift work sleep disorder
  • Gastroesophageal reflux disease that affects ability to tolerate a dinner close to bed time.
  • Chronic use of sedative hypnotics, anxiolytics, opiates
  • Use of medications that can affect circadian rhythm (beta blockers, melatonin)
  • Active smoking (may interfere with metabolism and CRU activities)
  • Diabetes (type 1 or 2)
  • Obesity (BMI≥30)
  • Pregnant or lactating female (pregnancy test will be required)
  • Professional or collegiate athlete

结局指标

主要结局

Free Fatty Acids (FFA, mmol/L)

时间窗: 2 visits, 4 weeks apart, each visit with 20 time points to assess change over time

Serial blood samples taken during visit, 20 time points per visit, 2 nights

Insulin (mcU/ml)

时间窗: 2 visits, 4 weeks apart, each visit with 20 time points to assess change over time

Serial blood samples taken during visit, 20 time points per visit, 2 nights

Triglycerides (mg/dl)

时间窗: 2 visits, 4 weeks apart, each visit with 20 time points to assess change over time

Serial blood samples taken during visit, 20 time points per visit, 2 nights

Oxidation of palmitate (mass spectroscopy)

时间窗: 2 visits, 4 weeks apart, each visit with 20 time points to assess change over time

Serial blood samples taken during visit, 20 time points per visit, 2 nights

Glucose (mg/dl)

时间窗: 2 visits, 4 weeks apart, each visit with 20 time points to assess change over time

Serial blood samples taken during visit, 20 time points per visit, 2 nights

次要结局

  • Polysomnography(1 sleep study per visit, 4 weeks apart)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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