N/A
N=60
The Impact of Intermittent Fasting on Human Metabolism and Cell Autophagy
Excessive Diet Restriction
Bottom Line
View on ClinicalTrials.gov: NCT02673515 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
May 2020
Primary outcome: Primary: Insulin Sensitivity (HOMA-IR) — 0.05; 0.06 no unit
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Alternate day fasting (Behavioral)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- Medical University of Graz
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Insulin Sensitivity (HOMA-IR) |
0.05; 0.06 | — |
| PRIMARY Insulin Sensitivity (QUICKI) |
0; 0 | — |
| PRIMARY Insulin Sensitivity (ISI-Index) |
0; 0 | — |
| PRIMARY Insulin Sensitivity (Matsuda-Index) |
-0.4; -0.7 | 0.797 |
| SECONDARY Blood Pressure (Systolic and Diastolic) |
-4.5; -1; -2.5; 0 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02673515). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.