|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT02673515 |
|
Date of registration:
|
24/11/2015 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
The Impact of Intermittent Fasting on Human Metabolism and Cell Autophagy
InterFast |
|
Scientific title:
|
The Impact of Intermittent Fasting on Human Metabolism and Cell Autophagy |
|
Date of first enrolment:
|
April 2015 |
|
Target sample size:
|
60 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02673515 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Austria
| | | | | | | |
|
Contacts
|
|
Name:
|
Thomas R Pieber, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Medical University Graz, Austria |
|
|
Name:
|
Frank Madeo, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Karl Franzens University Graz, Austria |
|
|
Name:
|
Harald Sourij, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Medical University of Graz, Auenbruggerplatz 15 |
|
|
Key inclusion & exclusion 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
Age minimum:
35 Years
Age maximum:
65 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Excessive Diet Restriction
|
|
Intervention(s)
|
|
Behavioral: Alternate day fasting
|
|
Primary Outcome(s)
|
|
Insulin Sensitivity (QUICKI)
[Time Frame: 4 weeks (from Baseline to 4 weeks)]
|
|
Insulin Sensitivity (HOMA-IR)
[Time Frame: 4 weeks (from Baseline to 4 weeks)]
|
|
Insulin Sensitivity (ISI-Index)
[Time Frame: 4 weeks (from Baseline to 4 weeks)]
|
|
Insulin Sensitivity (Matsuda-Index)
[Time Frame: 4 weeks (from Baseline to 4 weeks)]
|
|
Secondary Outcome(s)
|
|
Blood Pressure (Systolic and Diastolic)
[Time Frame: 4 weeks]
|
|
Secondary ID(s)
|
|
HS-2014-03
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|