NCT05806489

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 26, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2021

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 10, 2023

Completed
Last Updated

April 10, 2023

Status Verified

March 1, 2023

Enrollment Period

2 months

First QC Date

March 28, 2023

Last Update Submit

March 28, 2023

Conditions

Intermittent Fasting

Keywords

Blood GlucoseGlycemic variabilityIntermittent fastingCrossover Intervention

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Intermittent Fasting

EXPERIMENTAL
Other: Intermittent Fasting

Control Diet

PLACEBO COMPARATOR
Other: Control Diet

Interventions

Intermittent FastingOTHER

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.

Intermittent Fasting
Control DietOTHER

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.

Control Diet

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Food and Nutrition Research, Faculty of Food Technology

Osijek, 31000, Croatia

Location

MeSH Terms

Conditions

Intermittent Fasting

Condition Hierarchy (Ancestors)

FastingFeeding BehaviorBehavior

Study Officials

  • Ines Banjari, PhD

    University of Osijek, Croatia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Clinical Nutrition Specialist

Study Record Dates

First Submitted

March 28, 2023

First Posted

April 10, 2023

Study Start

January 26, 2021

Primary Completion

March 16, 2021

Study Completion

June 2, 2021

Last Updated

April 10, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

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).

Locations

CR(1)