Glycemic Variability in Intermittent Fasting (GLUInterm)

Effect of Intermittent Fasting on Glycaemic Variability in Healthy Subjects

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

Study Overview

• Status: Completed
• Conditions: Intermittent Fasting
• Intervention / Treatment: Other: Intermittent Fasting; Other: Control 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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Croatia
  • Osijek, Croatia, 31000
    • Department of Food and Nutrition Research, Faculty of Food Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control Diet	Other: 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.
Experimental: Intermittent Fasting	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.

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

Collaborators and Investigators

• Sponsor: Josip Juraj Strossmayer University of Osijek
• Investigators: Principal Investigator: Ines Banjari, PhD, University of Osijek, Croatia

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2021
• Primary Completion (Actual): March 16, 2021
• Study Completion (Actual): June 2, 2021

Study Registration Dates

• First Submitted: March 28, 2023
• First Submitted That Met QC Criteria: March 28, 2023
• First Posted (Actual): April 10, 2023

Study Record Updates

• Last Update Posted (Actual): April 10, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Blood Glucose; Intermittent fasting; Glycemic variability; Crossover Intervention
• Other Study ID Numbers: IBanjari-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All the results will be published (as journal manuscript) and freely accessible to all interested parties. Also, interested parties can contact investigators for any details regarding the study and results (for example if individual data is required for a meta-analysis).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No