How Often Should We Eat
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Purpose
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 differ between normal weight, obese, and pre-diabetic subjects.
The investigators will include 1) healthy, normal weight subjects 2) healthy, obese subjects and 3) subjects with pre-diabetes/IGT (impaired glucose tolerance). 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 the three or six meals per day. 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, obese, and pre-diabetic populations.
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.
| Condition | Intervention |
|---|---|
|
Intermittent Fasting Meal Frequency |
Behavioral: Meal frequency from 2 to 6 meals per day |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | VEK-H-3-2011-023. Fasting and Meal Project |
- oral glucose tolerance test [ Time Frame: 2 months ] [ Designated as safety issue: No ]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).
- Continuous glucose monitoring (CGM) [ Time Frame: 2 months ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 140 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Normal weight
Body Mass Index between 18-25 kg/m2 Age between 18-35 years male/female
|
Behavioral: Meal frequency from 2 to 6 meals per day
Each of the 140 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)
|
|
Experimental: Obese
Body Mass Index between 18-25 kg/m2 Age between 18-35 years Male/female
|
Behavioral: Meal frequency from 2 to 6 meals per day
Each of the 140 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)
|
|
Experimental: Obese with pre-diabetes (impaired glucose tolerance)
Body Mass Index between 18-25 kg/m2 Age between 18-35 years male/female
|
Behavioral: Meal frequency from 2 to 6 meals per day
Each of the 140 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)
|
Eligibility| Ages Eligible for Study: | 18 Years to 35 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
- Regular menses (cycles max 32 days)
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
- Positive pregnancy test
Contacts and Locations| Contact: Nina M Harder, MD | +45 35450898 | Nina.Majlund.Harder@rh.regionh.dk |
| Denmark | |
| Centre of Inflammation and Metabolism, Rigshospitalet | Recruiting |
| Copenhagen OE, Copenhagen, Denmark, 2100 | |
| Contact: Nina M Harder, MD +45 35450898 Nina.Majlund.Harder@rh.regionh.dk | |
| Study Director: | Bente K Pedersen, Professor | Rigshospitalet, Denmark |
More Information
No publications provided
| Responsible Party: | Inge Holm, CIM Administrator, Rigshospitalet, Denmark |
| ClinicalTrials.gov Identifier: | NCT01378208 History of Changes |
| Other Study ID Numbers: | VEK-H-3-2011-023 |
| Study First Received: | June 15, 2011 |
| Last Updated: | May 31, 2012 |
| Health Authority: | Denmark: The Danish National Committee on Biomedical Research Ethics for the Capital Region Denmark: Danish Dataprotection Agency |
Keywords provided by Rigshospitalet, Denmark:
|
Intermittent fasting Meal frequency obesity pre-diabetes |
ClinicalTrials.gov processed this record on May 22, 2013