HealthyNCT03532672
Early Effect of Fasting on Metabolic, Inflammatory, and Behavioral Responses in Females With and Without Obesity
A study testing Acute Fasting in people with Healthy and Obese, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial summary
The aim of this study is to investigate the effect of overnight fasting versus a diurnal fasting (during daily life activities) in females with and without obesity on inflammation, neurotrophins, energy metabolism, mood, food cravings, and appetite sensations. This study will be an acute fasting intervention. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- What is being tested?
- Acute Fasting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteBrazil
- Study dates
- 22 Sep 2017to 31 Dec 2022
- 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 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index between 18.5 and 24.9 kg/m² or equal or greater 35 kg/m²;
- Able to sign the informed consent.
Who cannot join
- Chronic health conditions (e.g., cancer, renal, heart or liver disorders, and autoimmune diseases), or history of thyroid alterations or use of related medications;
- Use of corticosteroids, immunosuppressors, anti-inflammatories, hypoglycemics, medications for weight loss, or any medication known to interfere with metabolic and inflammatory processes (e.g., corticosteroids, nonsteroidal anti-inflammatory drugs);
- Previous surgery for weight loss;
- Inability to eat any of the components of the standardized breakfast
- Pregnancy or breastfeeding;
- Smokingç
- Alcohol use (>2 doses/day).
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clínicas da Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, 30130-100
About this study
Official title: A Single Arm Trial Investigating the Acute Effect of Fasting on Metabolic, Inflammatory, and Behavioral Responses in Females With and Without Obesity
The aim of this study is to investigate the effect of overnight fasting versus a diurnal fasting (during daily life activities) in females with and without obesity on inflammation, neurotrophins, energy metabolism, mood, food cravings, and appetite sensations.
This study will be an acute fasting intervention.
- Being tested
- Acute Fasting
- Keywords
- Acute fasting, Inflammatory response, Energy Expenditure
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute FastingOther
The volunteers will fast overnight (10 hours) and breakfast will be offered (bread, butter, ham and industrialized fruit juice). The participants will fast for another 10 hours during daily activities.
| Study group | Role | What they receive |
|---|---|---|
| Acute fasting | Experimental | Participants will fast overnight for 10 hours (resting period), consume a santdardized breakfast, and fast during daily activities (active period) for another 10 hours. Receives: Other: Acute Fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose
Changes in blood glucose will be assessed at baseline and after 10 hours of fasting during daily activities
Measured: At baseline (after overnight fasting) and end (after 10 hours of fasting during the day) of the intervention period (~12 hours)
Lipid panel
Changes in lipid panel (i.e. total cholesterol, LDL, HDL and triglycerides) will be assessed at baseline and after 10 hours of fasting during daily activities
Measured: At baseline (after overnight fasting) and end (after 10 hours of fasting during the day) of the intervention period (~12 hours)
Interleukin 6
Changes in blood interleukin-6 will be assessed at baseline and after 10 hours of fasting during daily activities
Measured: At baseline (after overnight fasting) and end (after 10 hours of fasting during the day) of the intervention period (~12 hours)
Appetite sensations
Changes in hunger, satiety, fullness, and prospective food consumption will be assessed at baseline and after 10 hours of fasting during daily activities using a 100 mm visual analogue scale
Measured: At baseline (after overnight fasting) and end (after 10 hours of fasting during the day) of the intervention period (~12 hours)
Mood states
Changes in anger, confusion, depression, fatigue, tension, and vigor will be assessed using the Brunel Mood Scale
Measured: At baseline (after overnight fasting) and end (after 10 hours of fasting during the day) of the intervention period (~12 hours)
Secondary outcomes (3)
Gastrointestinal peptides
Changes in resting energy expenditure will be assessed at baseline and after 10 hours of fasting during daily activities using indirect calorimetry
Measured: At baseline (after overnight fasting) and end (after 10 hours of fasting during the day) of the intervention period (~12 hours)
Free fatty acids
Changes in free fatty acids will be assessed at baseline and after 10 hours of fasting during daily activities
Measured: At baseline (after overnight fasting) and end (after 10 hours of fasting during the day) of the intervention period (~12 hours)
Neurotrophic factors
Changes in brain-derived neurotrophic factor (BDNF), glial cell line-derived neurotrophic factor (GDNF), and nerve growth factor (NGF) will be assessed at baseline and after 10 hours of fasting during daily activities
Measured: At baseline (after overnight fasting) and end (after 10 hours of fasting during the day) of the intervention period (~12 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study start22 Sep 2017
- Primary completion26 Mar 2019
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adaliene Versiani M. Ferreira, Federal University of Minas Gerais
- Investigators
- Adaliene Versiani Matos Ferreira, PhD, Principal investigator, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03532672
- Sponsor's protocol ID
- Acute72774617.6.0000.5149
- Status last verified
- Mar 2025
- First submitted
- 7 May 2018
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tibaes JRB, Fagundes GB, Martins LB, Rodrigues AMDS, Campos AC, de Souza Cordeiro LM, Teixeira AL, Ferreira AVM. Effects of a single 10-hour daytime fasting intervention on mood and appetite in female adults with and without obesity: a real-world feasibility trial. Nutr Neurosci. 2025 Nov;28(11):1372-1385. doi: 10.1080/1028415X.2025.2514490. Epub 2025 Jun 10.
PubMed 40491423
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm Trial Investigating the Acute Effect of Fasting on Metabolic, Inflammatory, and Behavioral Responses in Females With and Without Obesity
- ClinicalTrials.gov ID
- NCT03532672
- Acronym / sponsor ID
- Acute72774617.6.0000.5149
- Keywords
- Acute fasting, Inflammatory response, Energy Expenditure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- 22 Sep 2017 (actual)
- Primary completion
- 26 Mar 2019 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 22 May 2018 (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 of this study is to investigate the effect of overnight fasting versus a diurnal fasting (during daily life activities) in females with and without obesity on inflammation, neurotrophins, energy metabolism, mood, food cravings, and appetite sensations.
This study will be an acute fasting intervention.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute fasting | Experimental | Other: Acute FastingParticipants will fast overnight for 10 hours (resting period), consume a santdardized breakfast, and fast during daily activities (active period) for another 10 hours. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body mass index between 18.5 and 24.9 kg/m² or equal or greater 35 kg/m²;
- Able to sign the informed consent.
Key exclusion criteria (7 listed)
- Chronic health conditions (e.g., cancer, renal, heart or liver disorders, and autoimmune diseases), or history of thyroid alterations or use of related medications;
- Use of corticosteroids, immunosuppressors, anti-inflammatories, hypoglycemics, medications for weight loss, or any medication known to interfere with metabolic and inflammatory processes (e.g., corticosteroids, nonsteroidal anti-inflammatory drugs);
- Previous surgery for weight loss;
- Inability to eat any of the components of the standardized breakfast
- Pregnancy or breastfeeding;
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 |
|---|---|---|
| Acute FastingThe volunteers will fast overnight (10 hours) and breakfast will be offered (bread, butter, ham and industrialized fruit juice). The participants will fast for another 10 hours during daily activities. | Other | Acute fasting |
Primary outcome
Blood glucose
Time frame: At baseline (after overnight fasting) and end (after 10 hours of fasting during the day) of the intervention period (~12 hours)
Changes in blood glucose will be assessed at baseline and after 10 hours of fasting during daily activities
Lipid panel
Time frame: At baseline (after overnight fasting) and end (after 10 hours of fasting during the day) of the intervention period (~12 hours)
Changes in lipid panel (i.e. total cholesterol, LDL, HDL and triglycerides) will be assessed at baseline and after 10 hours of fasting during daily activities
Interleukin 6
Time frame: At baseline (after overnight fasting) and end (after 10 hours of fasting during the day) of the intervention period (~12 hours)
Changes in blood interleukin-6 will be assessed at baseline and after 10 hours of fasting during daily activities
Appetite sensations
Time frame: At baseline (after overnight fasting) and end (after 10 hours of fasting during the day) of the intervention period (~12 hours)
Changes in hunger, satiety, fullness, and prospective food consumption will be assessed at baseline and after 10 hours of fasting during daily activities using a 100 mm visual analogue scale
Mood states
Time frame: At baseline (after overnight fasting) and end (after 10 hours of fasting during the day) of the intervention period (~12 hours)
Changes in anger, confusion, depression, fatigue, tension, and vigor will be assessed using the Brunel Mood Scale
3 secondary outcomes
Gastrointestinal peptides
Time frame: At baseline (after overnight fasting) and end (after 10 hours of fasting during the day) of the intervention period (~12 hours)
Free fatty acids
Time frame: At baseline (after overnight fasting) and end (after 10 hours of fasting during the day) of the intervention period (~12 hours)
Neurotrophic factors
Time frame: At baseline (after overnight fasting) and end (after 10 hours of fasting during the day) of the intervention period (~12 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 21 Mar 2025.
- Derived from this study: PubMed 40491423Tibaes JRB, Fagundes GB, Martins LB, Rodrigues AMDS, Campos AC, de Souza Cordeiro LM, Teixeira AL, Ferreira AVM. Effects of a single 10-hour daytime fasting intervention on mood and appetite in female adults with and without obesity: a real-world feasibility trial. Nutr Neurosci. 2025 Nov;28(11):1372-1385. doi: 10.1080/1028415X.2025.2514490. Epub 2025 Jun 10.
- 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.
Adaliene Versiani Matos Ferreira, PhD principal investigator
Federal University of Minas Gerais
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acute Fasting in people with Healthy and Obese, run by Federal University of Minas Gerais at 1 site in Brazil.
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 7 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 21 Mar 2025. 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 Brazil. 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?
Blood glucose (time frame: At baseline (after overnight fasting) and end (after 10 hours of fasting during the day) of the intervention period (~12 hours)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03532672, which also lists 1 linked publication.
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 21 Mar 2025.