Glycemic Variability in Intermittent Fasting

NCT ID: NCT05806489

Last Updated: 2023-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-26
• Study Completion Date: 2021-06-02

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.

Conditions

Intermittent Fasting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Intermittent Fasting

Group Type: EXPERIMENTAL

Intermittent Fasting

Intervention Type: OTHER

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

Group Type: PLACEBO_COMPARATOR

Control Diet

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Josip Juraj Strossmayer University of Osijek

OTHER

Sponsor Role: lead

Responsible Party

Ines Banjari

Associate Professor, Clinical Nutrition Specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ines Banjari, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Osijek, Croatia

Locations

Department of Food and Nutrition Research, Faculty of Food Technology

Osijek, , Croatia

Countries

Croatia

Other Identifiers

IBanjari-1

Identifier Type: -

Identifier Source: org_study_id