Intermittent FastingNCT01378208
How Often Should We Eat
A study testing Intermittent fasting - the effect on glucose metabolism, body composition and cognitive function in people with Intermittent Fasting and Meal Frequency, run by Inge Holm at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Intermittent Fasting, Meal Frequency
- What is being tested?
- Intermittent fasting - the effect on glucose metabolism, body composition and cognitive function
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2011to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Centre of Inflammation and Metabolism, Rigshospitalet
Copenhagen OE, Copenhagen, 2100
About this study
Official title: VEK-H-3-2011-023. Fasting and Meal Frequency Project
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.
Read more
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.
- Conditions
- Intermittent Fasting, Meal Frequency
- Being tested
- Intermittent fasting - the effect on glucose metabolism, body composition and cognitive function
- Keywords
- Intermittent fasting, Meal frequency, body composition, cognitive function, glucose metabolism
- Medical subject headings
- Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent fasting - the effect on glucose metabolism, body composition and cognitive functionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Normal weight | Experimental | Body Mass Index between 18-25 kg/m2 Age between 18-35 years male Receives: Behavioral: Intermittent fasting - the effect on glucose metabolism, body composition and cognitive function |
What is being measured
The primary outcome is the main question the study is designed to answer.
oral glucose tolerance test and cognitive function
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.
Measured: 2 months
Secondary outcomes (1)
Continuous glucose monitoring (CGM), body composition, and physical activity.
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intermittent FastingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inge Holm
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Inge Holm, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Bente K Pedersen, Professor, Study director, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01378208
- Sponsor's protocol ID
- VEK-H-3-2011-023
- Status last verified
- Nov 2013
- First submitted
- 15 Jun 2011
- Last updated
- 20 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VEK-H-3-2011-023. Fasting and Meal Frequency Project
- ClinicalTrials.gov ID
- NCT01378208
- Acronym / sponsor ID
- VEK-H-3-2011-023
- Conditions
- Intermittent Fasting, Meal Frequency
- Keywords
- Intermittent fasting, Meal frequency, body composition, cognitive function, glucose metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Inge HolmUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 22 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normal weight | Experimental | Behavioral: Intermittent fasting - the effect on glucose metabolism, body composition and cognitive functionBody Mass Index between 18-25 kg/m2 Age between 18-35 years male |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent fasting - the effect on glucose metabolism, body composition and cognitive functionEach 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 | Behavioural | Normal weight |
Primary outcome
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.
1 secondary outcome
Continuous glucose monitoring (CGM), body composition, and physical activity.
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bente K Pedersen, Professor study director
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent fasting - the effect on glucose metabolism, body composition and cognitive function in people with Intermittent Fasting and Meal Frequency, run by Inge Holm at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oral glucose tolerance test and cognitive function (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2013.