GLUInterm: Glycemic Variability in Intermittent Fasting

Sponsor

Josip Juraj Strossmayer University of Osijek (Other)

Overall Status

Completed

CT.gov ID

NCT05806489

Collaborator

(none)

Enrollment

Location

Arms

4.2

Actual Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Intermittent Fasting	Other: Intermittent Fasting Other: Control Diet	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

Effect of Intermittent Fasting on Glycaemic Variability in Healthy Subjects

Actual Study Start Date :

Jan 26, 2021

Actual Primary Completion Date :

Mar 16, 2021

Actual Study Completion Date :

Jun 2, 2021

Arms and Interventions

Arm	Intervention/Treatment
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.
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.

Arm

Intervention/Treatment

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.

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.

Outcome Measures

Primary Outcome Measures

Blood glucose [3 days per protocol]
Change in blood glucose
Glycemic variability [3 days per protocol]
Coefficient of Variation expressed as the ratio between standard deviation and mean blood glucose

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Food and Nutrition Research, Faculty of Food Technology	Osijek		Croatia	31000

Sponsors and Collaborators

Josip Juraj Strossmayer University of Osijek

Investigators

Principal Investigator: Ines Banjari, PhD, University of Osijek, Croatia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ines Banjari, Associate Professor, Clinical Nutrition Specialist, Josip Juraj Strossmayer University of Osijek

ClinicalTrials.gov Identifier:

NCT05806489

Other Study ID Numbers:

IBanjari-1

First Posted:

Apr 10, 2023

Last Update Posted:

Apr 10, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ines Banjari, Associate Professor, Clinical Nutrition Specialist, Josip Juraj Strossmayer University of Osijek

Blood Glucose

Glycemic variability

Intermittent fasting

Crossover Intervention

Study Results

No Results Posted as of Apr 10, 2023