Glycemic Variability in Intermittent Fasting

Study Overview
=================
Brief Summary
-----------------
The aim was to test the difference in glycemic variability after meal consumption during intermittent fasting and the usual diet.

Detailed Description
-----------------
Healthy participants were recruited for this crossover study aiming to determine the difference in glycemic variability after meal consumption while practicing intermittent fasting and the usual diet. Prior to the protocol assignment, participants were followed for 3 days - they were instructed to maintain their usual sleep pattern, level of physical activity and diet. Control of dietary pattern was conducted by using the 3-day food diary. Day zero was preparation day for the protocol (Intermittent fasting or Control diet) when all participants received individualized 3-day diet plan. Each protocol lasted 3 days with a 7-day washout period. Each protocol consisted of 3 meals per day, each providing a third of the total energy requirement. Control diet protocol was set at 12 hours eating/12 hours fasting, and Intermittent fasting protocol 6 hours eating/18 hours fasting. Blood glucose was measured at zero, 15, 30, 45 and 90 minutes after meal consumption. Before breakfast, blood glucose was measured also at minus 5 minutes prior meal consumption.

Official Title
-----------------
Effect of Intermittent Fasting on Glycaemic Variability in Healthy Subjects

Conditions
-----------------
Intermittent Fasting

Intervention / Treatment
-----------------
* Other: Intermittent Fasting
* Other: Control Diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body Mass Index in the range between 18.5 and 29.9 kg/m^2 stable sleep pattern (going to bed between 21:30h and midnight) for women: regular menstrual cycle lasting between 21 and 35 days, with average bleeding time 2 to 6 days Exclusion Criteria: Body Mass Index below 18.5 or above 29.9 kg/m^2 irregular sleeping pattern work in nightshift high intensity workout routine irregular dietary patterns (e.g. skipping meals) regularly fasting for more than 15 hours per day diagnosis of diabetes (or other conditions related to glycemic disorders) hypertension or other cardiovascular disease neurologic conditions disease affecting metabolism (like liver, kidney, thyroid or lung) use of medications for glycemia, hypertension, steroids, adrenergic stimulators, laxatives or supplements affecting glycemia, circadian rhythm, sleep or metabolism in general

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intermittent Fasting<br> | Other: Intermittent Fasting<br>* Participants received a 3-day individualized diet plan consisting of 3 meals per day. Meals needed to be consumed during 6 hours (while fasting for the remaining 18 hours). Diet plans were matched for energy and macronutrients.<br>|
| Placebo Comparator: Control Diet<br> | Other: Control Diet<br>* Participants received a 3-day individualized diet plan consisting of 3 meals per day. Meals needed to be consumed during 12 hours (while fasting for the remaining 12 hours). Diet plans were matched for energy and macronutrients.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose | Change in blood glucose | 3 days per protocol | 
| Glycemic variability | Coefficient of Variation expressed as the ratio between standard deviation and mean blood glucose | 3 days per protocol | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Blood Glucose, Glycemic variability, Intermittent fasting, Crossover Intervention