Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2011-06-30
2013-06-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Normal weight
Body Mass Index between 18-25 kg/m2 Age between 18-35 years male
Intermittent fasting - the effect on glucose metabolism, body composition and cognitive function
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
Interventions
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Intermittent fasting - the effect on glucose metabolism, body composition and cognitive function
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
Eligibility Criteria
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Inclusion Criteria
* Regular meal frequency, i.e. energy intake=energy utilized, and eating between 3-6 meals per day
Exclusion Criteria
* 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
18 Years
35 Years
MALE
Yes
Sponsors
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Inge Holm
OTHER
Responsible Party
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Inge Holm
CIM Administrator
Principal Investigators
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Bente K Pedersen, Professor
Role: STUDY_DIRECTOR
Rigshospitalet, Denmark
Locations
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Centre of Inflammation and Metabolism, Rigshospitalet
Copenhagen OE, Copenhagen, Denmark
Countries
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Other Identifiers
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VEK-H-3-2011-023
Identifier Type: -
Identifier Source: org_study_id