Excessive Diet Restriction
Conditions
Keywords
Alternate Day Fasting
Brief summary
InterFast is a Cohort study with an embedded randomized controlled pilot trial. Study participants will be healthy subjects and subjects who already practice Alternate Day Fasting. The trial will include 100 participants (50 Participants in Alternate Day Fasting group and 50 participants in the control group). Those participants in the control group will be asked to participate in a short randomized controlled trial, where they will be either allocated to an Alternative Day Fasting group or another control visit.
Detailed description
Intermittent fasting is a dietary regimen defined by alternating fasting and feeding cycles. In addition to caloric restriction (a dietary regimen limited to a daily food intake lower than one's daily caloric needs) only, intermittent fasting seems to activate cell autophagy (cellular recycling program) which potentially increases cellular stress resistance and removes accumulated molecules that are potentially toxic. In fact, mice maintained on intermittent fasting without decreased overall food intake show effects on body weight reduction that equal and in some cases even exceed those of calorie restriction. However, additionally, intermittent fasting combined with even a high-fat diet in the feeding periods protects mice from obesity, hyperinsulinemia, hepatic steatosis, and inflammation compared to controls that are fed an ad libitum high-fat diet despite the same calorie intake, making this intermittent fasting regimen a promising approach to reduce morbidity and mortality in various species. The best described and most widely practiced version of intermittent fasting is the alternate day diet or alternate day fasting (ADF). In animal models, ADF consists of an ad libitum feed day alternated with a 100% restriction fast day. However in humans, this is often modified to allow a small amount of food consumption on the fast day (e.g. 25% of the individual´s energy needs). Findings from recent modified ADF studies showed significant reductions in body weight. However, knowledge about the molecular effects of the alternate day diet on human metabolism or autophagy is still scarce since detailed analyses of molecular and metabolic parameters remain unexplored, especially in healthy individuals. The overarching aim of this research project is to elucidate in which extent alternate day fasting (and thereby intermittent fasting) influences human physiology in healthy individuals in both short and long term. The secondary objective of this study is to define novel molecular markers of aging and age-related diseases.
Interventions
BEHAVIORALAlternate day fasting
Subjects are requested to fast every other day. Calorie free fluids are allowed.
Sponsors
University of Graz
Medical University of Graz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Body mass index in the range of 22.0 - 27.0 kg/m2, * Fasting blood glucose \<110mg/dL (without medication) * LDL-cholesterol \<180 mg/dL (without medication) * Blood pressure \<140/90 mmHg (without medication) * Stable weight (change \<± 10%) for 3 months immediately prior to the study, * No history of metabolic disorders or cardiovascular disease * No acute or chronic inflammatory disorder * No current medications to regulate blood sugar, blood pressure or lipids or hormones * No heavy drinking (more than 15 drinks/week) * No use of tobacco or recreational drugs within past 5 years * No dietary restrictions (e.g. vegetarianism and vegan)
Exclusion criteria
* Known Malignancy * Women who are pregnant, breast-feeding or trying to become pregnant * History of any chronic disease process that could interfere with interpretation of study results * Women or men on hormonal supplementation or anti-conceptive hormonal medication for at least 2 months * Therapy with antidepressants within past 6 months * Regular therapy with acetylsalicylic acid
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insulin Sensitivity (HOMA-IR) | 4 weeks (from Baseline to 4 weeks) | HOMA-Index was calculated by using the following formula: HOMA-IR= FPG(mmol/l)\*FSI (U/l)/22.5 FSI=fasting serum insulin FPG=fasting plasma glucose |
| Insulin Sensitivity (QUICKI) | 4 weeks (from Baseline to 4 weeks) | QUICKI was calculated by using the following formula: QUICKI= log(FSI)+log (FPG) FSI=fasting serum insulin FPG=fasting plasma glucose |
| Insulin Sensitivity (ISI-Index) | 4 weeks (from Baseline to 4 weeks) | ISI was calculated by using the following formula: ISI=0,222-0,00333 x BMI-0,0000779 x Ins120-0,000422 x age FSI=fasting serum insulin FPG=fasting plasma glucose |
| Insulin Sensitivity (Matsuda-Index) | 4 weeks (from Baseline to 4 weeks) | Matsuda index was calculated by using the following formula: Matsuda-Index = 10000√(FPG∗FSI)∗(mean glucose\*mean insulin) FSI=fasting serum insulin FPG=fasting plasma glucose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure (Systolic and Diastolic) | 4 weeks | Change of blood pressure from Baseline to 4 weeks |
Countries
Austria
Participant flow
Recruitment details
After interviewing 462 adults for study eligibility based on previously set inclusion and exclusion criteria we have selected 60 representative study participants for the randomized controlled trial.
Participants by arm
| Arm | Count |
|---|---|
| Alternate Day Fasting Subjects are requested to alternate fast for 4 weeks (alternate an ad libitum feed day with a 100% restriction fast day).
Alternate day fasting: Subjects are requested to fast every other day. Calorie free fluids are allowed. | 30 |
| Control Group participants in the control group should be remaining on their usual diet | 30 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of motivation | 2 | 1 |
Baseline characteristics
| Characteristic | Alternate Day Fasting | Control Group | Total |
|---|---|---|---|
| Age, Continuous | 48 years | 50.5 years | 49 years |
| Body weight | 77.21 kg STANDARD_DEVIATION 10.25 | 75.93 kg STANDARD_DEVIATION 12.5 | 77.03 kg STANDARD_DEVIATION 11.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 28 Participants | 29 Participants | 57 Participants |
| Sex: Female, Male Female | 17 Participants | 17 Participants | 34 Participants |
| Sex: Female, Male Male | 11 Participants | 12 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Insulin Sensitivity (HOMA-IR)
HOMA-Index was calculated by using the following formula: HOMA-IR= FPG(mmol/l)\*FSI (U/l)/22.5 FSI=fasting serum insulin FPG=fasting plasma glucose
Time frame: 4 weeks (from Baseline to 4 weeks)
Population: per protocol analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alternate Day Fasting | Insulin Sensitivity (HOMA-IR) | 0.05 no unit | Standard Deviation 0.95 |
| Control Group | Insulin Sensitivity (HOMA-IR) | 0.06 no unit | Standard Deviation 0.8 |
Primary
Insulin Sensitivity (ISI-Index)
ISI was calculated by using the following formula: ISI=0,222-0,00333 x BMI-0,0000779 x Ins120-0,000422 x age FSI=fasting serum insulin FPG=fasting plasma glucose
Time frame: 4 weeks (from Baseline to 4 weeks)
Population: per protocol analysis
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Alternate Day Fasting | Insulin Sensitivity (ISI-Index) | 0 no unit |
| Control Group | Insulin Sensitivity (ISI-Index) | 0 no unit |
Primary
Insulin Sensitivity (Matsuda-Index)
Matsuda index was calculated by using the following formula: Matsuda-Index = 10000√(FPG∗FSI)∗(mean glucose\*mean insulin) FSI=fasting serum insulin FPG=fasting plasma glucose
Time frame: 4 weeks (from Baseline to 4 weeks)
Population: per protocol analysis
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Alternate Day Fasting | Insulin Sensitivity (Matsuda-Index) | -0.4 no unit |
| Control Group | Insulin Sensitivity (Matsuda-Index) | -0.7 no unit |
Comparison: Comparison of changes from baseline to 4 weeks between groups was tested with student´s t-test or Mann Whitney-U-Testp-value: 0.797t-test, 2 sided
Primary
Insulin Sensitivity (QUICKI)
QUICKI was calculated by using the following formula: QUICKI= log(FSI)+log (FPG) FSI=fasting serum insulin FPG=fasting plasma glucose
Time frame: 4 weeks (from Baseline to 4 weeks)
Population: per protocol analysis
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Alternate Day Fasting | Insulin Sensitivity (QUICKI) | 0 no unit |
| Control Group | Insulin Sensitivity (QUICKI) | 0 no unit |
Secondary
Blood Pressure (Systolic and Diastolic)
Change of blood pressure from Baseline to 4 weeks
Time frame: 4 weeks
Population: per protocol analysis
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Alternate Day Fasting | Blood Pressure (Systolic and Diastolic) | Systolic blood pressure | -4.5 mmHg |
| Alternate Day Fasting | Blood Pressure (Systolic and Diastolic) | Diastolic blood pressure | -2.5 mmHg |
| Control Group | Blood Pressure (Systolic and Diastolic) | Systolic blood pressure | -1 mmHg |
| Control Group | Blood Pressure (Systolic and Diastolic) | Diastolic blood pressure | 0 mmHg |