跳至主要内容
临床试验/NCT01378208
NCT01378208已完成不适用

VEK-H-3-2011-023. Fasting and Meal Frequency Project

Inge Holm2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2011年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
10
试验地点
2
主要终点
oral glucose tolerance test and cognitive function

研究概览

简要总结

The Danish Food Administration recommends eating three main meals and three small meals a day in order to maintain a healthy lifestyle. However, there is little research to support this concept- moreover, many studies shows that fasting can have a positive impact on our health.

HYPOTHESIS AND PURPOSE The investigators hypothesize, that the number of meals per day in order to maintain a healthy lifestyle will not differ in normal weight subjects.

The investigators will include 1) healthy, normal weight subjects. The investigators will study the effects of two daily meals.

More specifically, the investigators want to better understand how the body reacts to long-term, intermittent fasting (14 h /day for 4 weeks). The investigators will assess cognitive function, dietary intake, appetite regulation, fitness, glucose and insulin responses, as well as fat and muscle composition of the body before, during, and after the study.

Our long-term goals are to compare the effects of intermittent fasting with acute fasting. All of this is in an effort to establish how our eating habits ultimately affect our health and to, perhaps, contribute to new recommendations for healthy eating in normal weight population.

BACKGROUND Obesity and diabetes are increasing health threats facing the Western world today, despite abundant research efforts and campaigns to prevent such outcomes. Throughout the years, as the incidence of both obesity and diabetes in the general population has increased, so too has the typical number of daily meals. A once common three meals per day has now increased to six meals per day, in many instances. Recent animal research has shown that intermittent fasting (one or two meals per day) over a long period of time can improve cardiovascular health and prevent chronic diseases. Biochemically, fasting leads to an activation of metabolic mechanisms designed to preserve carbohydrates and increase the dependence on energy produced by the metabolism of fat. There is little scientific evidence regarding the number of meals per day that proves to be the healthiest, and those studies that do exist have opposing conclusions. Several theories do exist regarding the number of meals per day that affect us in the most favorable way, but these are just theories. Our study is the first to assess, in both a systematic and controlled setting, how long-term, intermittent fasting affects the human body.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Physically active, defined as at least 8,000 steps per day
  • Regular meal frequency, i.e. energy intake=energy utilized, and eating between 3-6 meals per day

排除标准

  • Daily medications
  • Acute illness within the past two weeks (infection, fever, or surgery)
  • Chronic disease, including cancer, heart, liver, kidney, and respiratory diseases, as well as metabolic diseases, such as diabetes
  • Alcohol abuse or more than 14/21 units (women/men) consumed per week
  • Smoking, including occasional smoking

结局指标

主要结局

oral glucose tolerance test and cognitive function

时间窗: 2 months

OGTT with stable isotopes. To see the effect of plasma glucose mmol/L and plasma insulin pmol/L 1 month after intervention (2 months from beginning of the study). Before, during, and after the intervention the subjects will complete cognitive tests for e.g. concentration, mood and appetite.

次要结局

  • Continuous glucose monitoring (CGM), body composition, and physical activity.(2 months)

研究者

发起方
Inge Holm
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Inge Holm

CIM Administrator

Rigshospitalet, Denmark

研究点 (2)

Loading locations...

相似试验