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OpenTrials
Completed

NCT Number: NCT01378208

How Often Should We Eat

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.

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Key information

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Centre of Inflammation and Metabolism, Rigshospitalet

Copenhagen OE, Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Intermittent fasting - the effect on glucose metabolism, body composition and cognitive function

Behavioral

Each of the 10 subjects must through a period of monitoring (four weeks) before the study period (four weeks). Before, during, and after both the monitoring period and the study period, the subjects will undergo tests at Rigshospitalet.

DAY 1: Inclusion and exclusion of subjects DAY 1 to DAY 28: Monitoring period (usual lifestyle)

  • 28 days of dietary monitoring
  • 28 days measurement by pedometer DAY 1, DAY 28 & DAY 56: Test 1
  • Oral glucose tolerance test with stable isotopes
  • Fat and muscle biopsies DAY 2, DAY 29 & DAY 57: Test 2
  • DXA scanning
  • Resting Metabolic Rate Measurement
  • VO2max test on bicycle
  • Cognitive testing
  • MRI of the brain and abdomen DAY 9, DAY 19, DAY 38 & DAY 48: Test 3
  • Actiheart for 3 days
  • 72-hour blood glucose monitoring with CGMS System DAY 29 to DAY 57: INTERVENTION
  • Fasting from 7am - 9pm
  • 28 days of dietary monitoring
  • 28 days measurement by pedometer

Primary outcomes

  1. oral glucose tolerance test and cognitive function

    Time frame: 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.

Secondary outcomes

  1. Continuous glucose monitoring (CGM), body composition, and physical activity.

    Time frame: 2 months

    During the control period and the intervention the CGM system will measure the continuous glucose concentration (each 5 min), and thereby any change will be measured. Before, during, and after the intervention the subjects body composition will be determined by weight, hip, waist, and with DXA and MRI scans. Furthermore, physical activity will be assessed by Actiheart and VO2 max tests.

Sponsors and collaborators

Lead sponsor

Inge Holm

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jun 22, 2011
Registry last updated
Nov 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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