Overweight and ObesityNCT04293003
Metabolic Effects of Morning 16/8 Fasting
A study testing fasting, Low carbohydrate and Mediterranean in people with Overweight and Obesity, run by National and Kapodistrian University of Athens at 1 site in Greece.
Trial summary
A study to address the effects of early-day fasting on fat tissue mobilization in comparison to a typical isocaloric Mediterranean and a low-carbohydrate breakfast. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- fasting, Low carbohydrate and Mediterranean
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteGreece
- Study dates
- 7 Jan 2020to 29 Feb 2020
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 18-25 kg/m2
- Willfulness to participate
Who cannot join
- Overweight or obesity (BMI>25 kg/m2)
- Type 1 or 2 diabetes mellitus
- Uncontrolled thyroid disorders
Trial locations and contacts
1 site in 1 country.
Greece1 site
Diabetes Clinical Research Laboratory, 1st Department of Propaedeutic Internal Medicine
Athens, 11527
About this study
Official title: Short-term Metabolic Effects of Morning Energy Restriction Versus Two Different Early-day Nutrition Strategies
A study to address the effects of early-day fasting on fat tissue mobilization in comparison to a typical isocaloric Mediterranean and a low-carbohydrate breakfast.
Read the detailed description
The study design meets a cross-over pattern with 3 different morning visits of 6 hour duration each. After an informed consent is received from the participant, a crude medical history, physical examination and collection of somatometric data through bio-impendance analysis will take place. An intravenous catheter will be placed in the participants forearm.
At zero time point, depending on study visit, participants will either (A) remain fasted (B) start consuming ta pre-prepared zero-carbohydrate 500 kcal test meal (C) start consuming ta pre-prepared 500 kcal test meal with a composition conforming to a standard Mediterannean breakfast. Participants will be given 10 minutes to consume the meal.
Blood samples will be drawn and visual analogue scales (VAS) for hunger and satiety will be filled in at the following time points (min): -15, 0, 15, 30, 60, 90, 120, 180, 240, 300, 360.
- Conditions
- Overweight and Obesity
- Being tested
- fasting, Low carbohydrate, Mediterranean
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fastingOther
6-hour fasting
Low carbohydrateOther
Consumption of a zero-carbohydrate breakfast
MediterraneanOther
Consumption of a Mediterranean-type breakfast
| Study group | Role | What they receive |
|---|---|---|
| Fasting | Experimental | 6-hour morning fasting Receives: Other: fasting |
| Low carbohydrate | Experimental | Consumption of a zero-carbohydrate breakfast Receives: Other: Low carbohydrate |
| Mediterranean | Experimental | Consumption of a Mediterranean breakfast Receives: Other: Mediterranean |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mobilisation of adipose tissue
Area Under the Curve (AUC) of free fatty acid (FFA) and beta-Hydroxybutyrate (bOB) concentration
Measured: 6 hours
Secondary outcomes (3)
Mobilisation of gut peptides
AUC of Ghrelin, Peptide YY and glucagon-like peptide -1 (GLP-1) concentration
Measured: 6 hours
Degree of appetite suppression
Visual Analogue Scale score (0-10, 0 equals minimal and 10 equals highest) for appetite
Measured: 6 hours
Degree of satiety induction
Visual Analogue Scale score (0-10, 0 equals minimal and 10 equals highest) for satiety
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start7 Jan 2020
- Primary completion29 Feb 2020
- Study completion29 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandros Kokkinos, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04293003
- Sponsor's protocol ID
- 39/12-02-2019
- Status last verified
- Mar 2020
- First submitted
- 1 Mar 2020
- Last updated
- 19 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Metabolic Effects of Morning Energy Restriction Versus Two Different Early-day Nutrition Strategies
- ClinicalTrials.gov ID
- NCT04293003
- Acronym / sponsor ID
- 39/12-02-2019
- Conditions
- Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- 7 Jan 2020 (actual)
- Primary completion
- 29 Feb 2020 (actual)
- Study completion
- 29 Feb 2020 (actual)
- First posted
- 3 Mar 2020 (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.
A study to address the effects of early-day fasting on fat tissue mobilization in comparison to a typical isocaloric Mediterranean and a low-carbohydrate breakfast.
Detailed description
The study design meets a cross-over pattern with 3 different morning visits of 6 hour duration each. After an informed consent is received from the participant, a crude medical history, physical examination and collection of somatometric data through bio-impendance analysis will take place. An intravenous catheter will be placed in the participants forearm.
At zero time point, depending on study visit, participants will either (A) remain fasted (B) start consuming ta pre-prepared zero-carbohydrate 500 kcal test meal (C) start consuming ta pre-prepared 500 kcal test meal with a composition conforming to a standard Mediterannean breakfast. Participants will be given 10 minutes to consume the meal.
Blood samples will be drawn and visual analogue scales (VAS) for hunger and satiety will be filled in at the following time points (min): -15, 0, 15, 30, 60, 90, 120, 180, 240, 300, 360.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fasting | Experimental | Other: fasting6-hour morning fasting |
| Low carbohydrate | Experimental | Other: Low carbohydrateConsumption of a zero-carbohydrate breakfast |
| Mediterranean | Experimental | Other: MediterraneanConsumption of a Mediterranean breakfast |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI 18-25 kg/m2
- Willfulness to participate
Key exclusion criteria (3 listed)
- Overweight or obesity (BMI>25 kg/m2)
- Type 1 or 2 diabetes mellitus
- Uncontrolled thyroid disorders
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 |
|---|---|---|
| fasting6-hour fasting | Other | Fasting |
| Low carbohydrateConsumption of a zero-carbohydrate breakfast | Other | Low carbohydrate |
| MediterraneanConsumption of a Mediterranean-type breakfast | Other | Mediterranean |
Primary outcome
Mobilisation of adipose tissue
Time frame: 6 hours
Area Under the Curve (AUC) of free fatty acid (FFA) and beta-Hydroxybutyrate (bOB) concentration
3 secondary outcomes
Mobilisation of gut peptides
Time frame: 6 hours
Degree of appetite suppression
Time frame: 6 hours
Degree of satiety induction
Time frame: 6 hours
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 19 Mar 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fasting, Low carbohydrate and Mediterranean in people with Overweight and Obesity, run by National and Kapodistrian University of Athens at 1 site in Greece.
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 2 inclusion and 3 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 19 Mar 2020. 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 Greece. 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. 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?
Mobilisation of adipose tissue (time frame: 6 hours). 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 19 Mar 2020.