Intermittent FastingGLUIntermNCT05806489
Glycemic Variability in Intermittent Fasting
A study testing Intermittent Fasting in people with Intermittent Fasting, run by Josip Juraj Strossmayer University of Osijek at 1 site in Croatia.
Trial summary
The aim was to test the difference in glycemic variability after meal consumption during intermittent fasting and the usual diet. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Intermittent Fasting
- What is being tested?
- Intermittent Fasting
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteCroatia
- Study dates
- 26 Jan 2021to 2 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Croatia1 site
Department of Food and Nutrition Research, Faculty of Food Technology
Osijek, 31000
About this study
Official title: 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.
Read the 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
- Being tested
- Intermittent Fasting, Control Diet
- Keywords
- Blood Glucose, Glycemic variability, Intermittent fasting, Crossover Intervention
- Medical subject headings
- Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent Fasting | Experimental | Not described Receives: Other: Intermittent Fasting |
| Control Diet | Placebo comparator | Not described Receives: Other: Control Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose
Change in blood glucose
Measured: 3 days per protocol
Glycemic variability
Coefficient of Variation expressed as the ratio between standard deviation and mean blood glucose
Measured: 3 days per protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start26 Jan 2021
- Primary completion16 Mar 2021
- Study completion2 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intermittent FastingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Josip Juraj Strossmayer University of Osijek
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ines Banjari, Josip Juraj Strossmayer University of Osijek
- Investigators
- Ines Banjari, PhD, Principal investigator, University of Osijek, Croatia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05806489
- Sponsor's protocol ID
- IBanjari-1
- Acronym
- GLUInterm
- Status last verified
- Mar 2023
- First submitted
- 28 Mar 2023
- Last updated
- 10 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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).
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intermittent Fasting on Glycaemic Variability in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05806489
- Acronym / sponsor ID
- GLUInterm / IBanjari-1
- Conditions
- Intermittent Fasting
- Keywords
- Blood Glucose, Glycemic variability, Intermittent fasting, Crossover Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Josip Juraj Strossmayer University of OsijekUniversity, hospital or other
- Study start
- 26 Jan 2021 (actual)
- Primary completion
- 16 Mar 2021 (actual)
- Study completion
- 2 Jun 2021 (actual)
- First posted
- 10 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent Fasting | Experimental | Other: Intermittent Fasting |
| Control Diet | Placebo comparator | Other: Control Diet |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent FastingParticipants 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. | Other | Intermittent Fasting |
| Control DietParticipants 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. | Other | Control Diet |
Primary outcome
Blood glucose
Time frame: 3 days per protocol
Change in blood glucose
Glycemic variability
Time frame: 3 days per protocol
Coefficient of Variation expressed as the ratio between standard deviation and mean blood glucose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
- Individual participant dataSharing planned: No. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ines Banjari, PhD principal investigator
University of Osijek, Croatia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Fasting in people with Intermittent Fasting, run by Josip Juraj Strossmayer University of Osijek at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood glucose (time frame: 3 days per protocol). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2023.