Glycemic Variability in Intermittent Fasting

Intermittent Fasting Clinical Trial

— GLUInterm  

Official title:

Effect of Intermittent Fasting on Glycaemic Variability in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05806489
• Other study ID #: IBanjari-1
• Status: Completed
• Phase: N/A
• Start date: January 26, 2021
• Est. completion date: June 2, 2021

Study information

• Verified date: March 2023
• Source: Josip Juraj Strossmayer University of Osijek
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim was to test the difference in glycemic variability after meal consumption during intermittent fasting and the usual diet.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2, 2021
• Est. primary completion date: March 16, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Intermittent Fasting

Intervention

Other:
• Intermittent Fasting
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.
• Control Diet
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.

Locations

Country	Name	City	State
Croatia	Department of Food and Nutrition Research, Faculty of Food Technology	Osijek

Sponsors (1)

Lead Sponsor	Collaborator
Josip Juraj Strossmayer University of Osijek

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood glucose	Change in blood glucose	3 days per protocol
Primary	Glycemic variability	Coefficient of Variation expressed as the ratio between standard deviation and mean blood glucose	3 days per protocol