Overweight and ObesityNCT03574103
Chronic Effect of Fasting
A study testing Caloric restriction only, Caloric restriction plus TRF morning and Caloric restriction plus TRF night in people with Overweight and Obesity, run by Federal University of Minas Gerais at 2 sites in Brazil.
Trial summary
The aim of the study is to determine if time-restricted feeding (TRF) is an effective dietary strategy to weight loss after 8 weeks intervention. TRF will be compared with an intervention without restriction in time for feeding. Both strategies will be with caloric restriction. Read more about this study
- Who is it for?
- Ages 18 to 59 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Caloric restriction only, Caloric restriction plus TRF morning and Caloric restriction plus TRF night
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesBrazil
- Study dates
- 9 Jul 2018to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 59 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Females;
- Aged between 18 and 59 years old;
- Body mass index equal or greater 25 kg/m²;
- Agree to sign the informed consent.
Who cannot join
- Any chronic health conditions (e.g. chronic renal failure, autoimmune, heart, and liver disease);
- Thyroid diseases or medications for its treatment;
- Medications known to affect total energy expenditure;
- Use of steroids, immunosuppressants or non-steroidal anti-inflammatory drugs, weight-loss medications, oral hypoglycemic agents or insulin and any medications that influence metabolic and/or inflammatory parameters;
- Previous surgery for weight loss;
- Pregnancy or breast-feeding;
- Smoking;
- Alcohol use (>2 doses/day).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil2 sites, 2 recruiting
- Recruiting
Hospital da Clínicas
Belo Horizonte, Minas Gerais, 30130-100
Adaliene VM Ferreira, PhD, +553134093680, adaliene@gmail.com
- Recruiting
Hospital das Clínicas
Belo Horizonte, Minas Gerais, 30130-100
Adaliene VM Ferreira, PhD, +553134093680, adaliene@gmail.com
About this study
Official title: Comparison of Weight Loss Induced by Daily Time-Restricted Feeding Versus Daily Caloric Restriction in Women With Overweight and Obesity
The aim of the study is to determine if time-restricted feeding (TRF) is an effective dietary strategy to weight loss after 8 weeks intervention. TRF will be compared with an intervention without restriction in time for feeding. Both strategies will be with caloric restriction.
Read the detailed description
The participants of the study will be divided in two groups: (1) a group with caloric restriction and without restriction in time for feeding and (2) a group with caloric restriction and restriction in time for feeding. This second group will be subdivided according to the participant's preference: (2.1) first meal at 8 a.m. and last meal at 4 p.m. or (2.2) first meal at 12 p.m. and last meal at 8 p.m. The caloric restriction for all participants will be 513 to 770 kcal from estimated energy requirement.
- Conditions
- Overweight and Obesity
- Being tested
- Caloric restriction only, Caloric restriction plus TRF morning, Caloric restriction plus TRF night
- Keywords
- Obesity, Overweight, Weight loss, Fasting
- Medical subject headings
- Overweight, Obesity, Weight Loss, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caloric restriction onlyBehavioural
Participants in this group will receive a eating plan with caloric restriction (513 to 770 kcal from estimated energy requirements), without restriction in time for feeding, for 8 weeks.
Caloric restriction plus TRF morningBehavioural
Participants in this group will receive a eating plan with caloric restriction (513 to 770 kcal from estimated energy requirements) and 8 hours for eating (from 12 p.m. to 8 p.m.) and 16 hours of fasting, for 8 weeks.
Caloric restriction plus TRF nightBehavioural
Participants in this group will receive a eating plan with caloric restriction (513 to 770 kcal from estimated energy requirements) and 8 hours for eating (from 8 a.m. to 4 p.m.) and 16 hours of fasting, for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Caloric restriction only | Active comparator | Participants in this group will receive a eating plan with caloric restriction as dietary weight loss strategy. Receives: Behavioral: Caloric restriction only |
| Caloric restriction plus TRF morning | Experimental | Participants in this group will receive a eating plan with caloric and time restriction as dietary weight loss strategy. Receives: Behavioral: Caloric restriction plus TRF morning |
| Caloric restriction plus TRF night | Experimental | Participants in this group will receive a eating plan with caloric and time restriction as dietary weight loss strategy. Receives: Behavioral: Caloric restriction plus TRF night |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
Body weight will be assessed by mechanical scale
Measured: Baseline and weeks 2, 4 and 8
Secondary outcomes (9)
Change in body composition
Body composition will be assessed by electrical bioimpedance
Measured: Baseline and weeks 2, 4 and 8
Change in resting energy expenditure
Resting energy expenditure will be assessed by indirect calorimetry
Measured: Baseline and weeks 2, 4 and 8
Change in self-reported energy intake
Dietary energy intake will be assessed with 3-days food records
Measured: Baseline and weeks 2, 4 and 8
Change in self-reported diet composition
Dietary macronutrient intake will be assessed with 3-days food records
Measured: Baseline and weeks 2, 4 and 8
Change in self-reported intervention adherence
Adherence will be assessed by daily record of feeding hours
Measured: Baseline and weeks 2, 4 and 8
Change in metabolic profile
Fasting lipids, glucose and free fatty acids
Measured: Baseline and weeks 2, 4 and 8
Change in self-reported stress
Self-reported stress will be assessed by a questionnaire (Perceived Stress Scale). The total of the scale is a sum of scores of 14 questions. Total score can range from zero to 56. The higher the score, the higher the level of stress.
Measured: Baseline and weeks 2, 4 and 8
Change in self-reported anxiety
Self-reported anxiety will be assessed by a questionnaire (Beck Anxiety Inventory). The questionnaire consists of 21 items and the severity of each of them scored from 0 to 3. The degree of anxiety will be classified according to the final score obtained: 0-7 absent or minimum; 8-15 light; 16-25 moderate; 26-63 severe.
Measured: Baseline and weeks 2, 4 and 8
Change in self-reported depression
Self-reported depression will be assessed by a questionnaire (Beck Depression Inventory). The questionnaire consists of 21 items and the severity of each one scored from 0 to 3. The volunteers will be classified according to the score obtained: BDI ≤ 15: without depression; 16 ≤ BDI ≤ 20: dysphoria; BDI> 20: depression.
Measured: Baseline and weeks 2, 4 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2018
- Study start9 Jul 2018
- Primary completionSep 2025 (estimated)
- Study completionDec 2026 (estimated)
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 Overweight and ObesityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03574103
- Sponsor's protocol ID
- Chronic 72774617.6.0000.5149
- Status last verified
- Mar 2025
- First submitted
- 19 Jun 2018
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.
PubMed 33512717
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Weight Loss Induced by Daily Time-Restricted Feeding Versus Daily Caloric Restriction in Women With Overweight and Obesity
- ClinicalTrials.gov ID
- NCT03574103
- Acronym / sponsor ID
- Chronic 72774617.6.0000.5149
- Conditions
- Overweight and Obesity
- Keywords
- Obesity, Overweight, Weight loss, Fasting
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- 9 Jul 2018 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 Jun 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 the study is to determine if time-restricted feeding (TRF) is an effective dietary strategy to weight loss after 8 weeks intervention. TRF will be compared with an intervention without restriction in time for feeding. Both strategies will be with caloric restriction.
Detailed description
The participants of the study will be divided in two groups: (1) a group with caloric restriction and without restriction in time for feeding and (2) a group with caloric restriction and restriction in time for feeding. This second group will be subdivided according to the participant's preference: (2.1) first meal at 8 a.m. and last meal at 4 p.m. or (2.2) first meal at 12 p.m. and last meal at 8 p.m. The caloric restriction for all participants will be 513 to 770 kcal from estimated energy requirement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Caloric restriction only | Active comparator | Behavioral: Caloric restriction onlyParticipants in this group will receive a eating plan with caloric restriction as dietary weight loss strategy. |
| Caloric restriction plus TRF morning | Experimental | Behavioral: Caloric restriction plus TRF morningParticipants in this group will receive a eating plan with caloric and time restriction as dietary weight loss strategy. |
| Caloric restriction plus TRF night | Experimental | Behavioral: Caloric restriction plus TRF nightParticipants in this group will receive a eating plan with caloric and time restriction as dietary weight loss strategy. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Females;
- Aged between 18 and 59 years old;
- Body mass index equal or greater 25 kg/m²;
- Agree to sign the informed consent.
Key exclusion criteria (8 listed)
- Any chronic health conditions (e.g. chronic renal failure, autoimmune, heart, and liver disease);
- Thyroid diseases or medications for its treatment;
- Medications known to affect total energy expenditure;
- Use of steroids, immunosuppressants or non-steroidal anti-inflammatory drugs, weight-loss medications, oral hypoglycemic agents or insulin and any medications that influence metabolic and/or inflammatory parameters;
- Previous surgery for weight loss;
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 |
|---|---|---|
| Caloric restriction onlyParticipants in this group will receive a eating plan with caloric restriction (513 to 770 kcal from estimated energy requirements), without restriction in time for feeding, for 8 weeks. | Behavioural | Caloric restriction only |
| Caloric restriction plus TRF morningParticipants in this group will receive a eating plan with caloric restriction (513 to 770 kcal from estimated energy requirements) and 8 hours for eating (from 12 p.m. to 8 p.m.) and 16 hours of fasting, for 8 weeks. | Behavioural | Caloric restriction plus TRF morning |
| Caloric restriction plus TRF nightParticipants in this group will receive a eating plan with caloric restriction (513 to 770 kcal from estimated energy requirements) and 8 hours for eating (from 8 a.m. to 4 p.m.) and 16 hours of fasting, for 8 weeks. | Behavioural | Caloric restriction plus TRF night |
Primary outcome
Change in body weight
Time frame: Baseline and weeks 2, 4 and 8
Body weight will be assessed by mechanical scale
9 secondary outcomes
Change in body composition
Time frame: Baseline and weeks 2, 4 and 8
Change in resting energy expenditure
Time frame: Baseline and weeks 2, 4 and 8
Change in self-reported energy intake
Time frame: Baseline and weeks 2, 4 and 8
Change in self-reported diet composition
Time frame: Baseline and weeks 2, 4 and 8
Change in self-reported intervention adherence
Time frame: Baseline and weeks 2, 4 and 8
Change in metabolic profile
Time frame: Baseline and weeks 2, 4 and 8
Change in self-reported stress
Time frame: Baseline and weeks 2, 4 and 8
Change in self-reported anxiety
Time frame: Baseline and weeks 2, 4 and 8
Change in self-reported depression
Time frame: Baseline and weeks 2, 4 and 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Derived from this study: PubMed 33512717Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.
- Individual participant dataSharing planned: Undecided
Related trials for Overweight and Obesity
Active, not recruiting
Effect of the Thrive AI Health App on Lifestyle Behaviors and Quality of Life
Diabetes Type 2, Overweight or Obesity
RecruitingObservational study
AI-Driven Metabolic Cohort in Overweight/Obese Chinese Adults
Overweight and Obesity, Diabetes Mellitus, Type 2
RecruitingPhase 2
Safety and Efficacy of ABBV-295 in Adults With Obesity or Overweight With Weight-Related Comorbidities
Obesity, Overweight
Not yet recruiting
SHIFT-TB: Nutrition Intervention and Evaluation
Underweight, Overweight and Obesity
Not yet recruiting
Mazdutide for Reducing Atrial Fibrillation Recurrence After Catheter Ablation in Obese Patients
Atrial Fibrillation (AF), Ablation Treatment
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caloric restriction only, Caloric restriction plus TRF morning and Caloric restriction plus TRF night in people with Overweight and Obesity, run by Federal University of Minas Gerais at 2 sites 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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 18 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 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adaliene VM Ferreira, PhD (+553134093680, adaliene@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight (time frame: Baseline and weeks 2, 4 and 8). 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 NCT03574103, 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 18 Mar 2025; AzTrials last refreshed its copy on 28 Oct 2026.