Time Restricted FeedingNCT04647149

Effects of Early and Delayed Time-restricted Eating in Adults With Overweight and Obesity

A study testing Dietary Approach in people with Time Restricted Feeding and Intermittent Fasting, run by Federal University of Rio Grande do Sul at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 20 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Time Restricted Feeding, Intermittent Fasting, Obesity
What is being tested?: Dietary Approach
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 1 siteBrazil
Study dates: 3 Sep 2019to 12 May 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 20 to 40 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Male and female;
Body mass index (BMI) between 25 and 34.9 kg/m²;
Age between 20 and 40 years;
Not engaged in any structured exercise program;
Weight stable for ~3 months prior to the beginning of the study;
Able to give written informed consent.

Who cannot join

Current smoker;
Cardiometabolic diseases (dyslipidemia, diabetes, hypertension, etc);
Current treatment with medication or supplements which significantly affect the main studied variables;
Night-shift workers;
Night eating syndrome;
Irregular sleep patterns;

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For women: pregnancy, planned pregnancy (within the study period), lactating or menopause;
Habitual fasting window >16 hours;
Concomitant participation in other studies.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Universidade Federal do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90690-200

Other trials in Brazil

About this study

Official title: Effects of Early and Delayed Time-Restricted Eating on Body Weight and Metabolic Parameters in Adults With Overweight and Obesity

Time-restricted eating (TRE) is a dietary approach that aims to increase fasting time and decrease the eating window. Promising TRE effects on weight loss and some cardiometabolic risk factors have been reported. However, there is a lack of randomized clinical trials that directly investigate the effect of TRE at different times of the day (early vs. delayed) in individuals with overweight and obesity. The present study investigates the effects of 8 weeks of TRE performed at different moments of the day on body composition and cardiometabolic parameters in adults with overweight and obesity.

Conditions: Time Restricted Feeding, Intermittent Fasting, Obesity, Overweight and Obesity
Being tested: Dietary Approach
Medical subject headings: Intermittent Fasting, Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dietary ApproachBehavioural
Dietary approaches with energy restriction performed at different times of the day.

Study groups in NCT04647149
Study group	Role	What they receive
Early Time-Restricted Eating	Experimental	8-hour eating window between 08:00 and 16:00 Receives: Behavioral: Dietary Approach
Delayed Time-Restricted Eating	Experimental	8-hour eating window between 12:00 and 20:00 Receives: Behavioral: Dietary Approach
Control	Experimental	12-hour eating window between 08:00 and 20:00 Receives: Behavioral: Dietary Approach

What is being measured

The primary outcome is the main question the study is designed to answer.

Insulin resistance (indices)
Including but not limited to Homeostatic Model Assessment for Insulin Resistance (HOMA-IR).
Measured: Change from baseline. Measured at baseline and after 8 weeks.
Fasting insulin levels (µIU/mL)
Measured by enzyme-Linked Immunosorbent Assay
Measured: Change from baseline. Measured at baseline and after 8 weeks.
Fasting glucose levels (mg/dL)
Measured by colorimetric method
Measured: Change from baseline. Measured at baseline and after 8 weeks.
Insulin Sensitivity (indices)
Including but not limited to the Matsuda index
Measured: Change from baseline. Measured at baseline and after 8 weeks.
Glucose tolerance
Measured by oral glucose tolerance test (OGTT; 0,30,60,90, and 120 min)
Measured: Change from baseline. Measured at baseline and after 8 weeks.
Fasting lipid profile levels (mg/dL)
Measured by colorimetric method
Measured: Change from baseline. Measured at baseline and after 8 weeks.

Secondary outcomes (15)

β cell function (indices)
Including but not limited to HOMA-BETA
Measured: Change from baseline. Measured at baseline and after 8 weeks.
Fat Mass (kg)
Measured by Dual-energy X-ray Absorptiometry under fasting condition.
Measured: Change from baseline. Measured at baseline and after 8 weeks.
Fat Percentage (%)
Measured by Dual-energy X-ray Absorptiometry under fasting condition.
Measured: Change from baseline. Measured at baseline and after 8 weeks.
Fat Free Mass (kg)
Measured by Dual-energy X-ray Absorptiometry under fasting condition.
Measured: Change from baseline. Measured at baseline and after 8 weeks.
Body Weight (kg)
Measured by Dual-energy X-ray Absorptiometry under fasting condition.
Measured: Change from baseline. Measured at baseline and after 8 weeks.
Body Weight (kg)
Measured on a digital scale.
Measured: Change from baseline. Measured at baseline and after 4, and 8 weeks.
Bone Mineral Content (kg)
Measured by Dual-energy X-ray Absorptiometry under fasting condition.
Measured: Change from baseline. Measured at baseline and after 8 weeks.
Body Mass Index (kg/m^2)
Calculated from weight in kilograms divided by height in meters squared.
Measured: Change from baseline. Measured at baseline and after 8 weeks.
Fasting ketones (β-hydroxybutyrate) levels (mmol/L)
Measured: Change from baseline. Measured at baseline and after 8 weeks.
Resting metabolic rate (Kcal/day)
Measured by indirect calorimetry under resting and fasting conditions.
Measured: Change from baseline. Measured at baseline and after 8 weeks.
Substrate Oxidation (respiratory exchange ratio)
Measured by indirect calorimetry under resting and fasting conditions.
Measured: Change from baseline. Measured at baseline and after 8 weeks.
Peak oxygen consumption (mL/min and mL/kg/min)
Measured by an open-circuit spirometry system
Measured: Change from baseline. Measured at baseline and after 8 weeks.
Quality of sleep
Measured by Pittsburgh Sleep Quality Index Questionnaire. Higher scores indicate worse sleep quality.
Measured: Change from baseline. Measured at baseline and after 8 weeks.
Risk of binge eating
Measured by binge eating scale. Higher scores indicate greater risk of binge eating.
Measured: Change from baseline. Measured at baseline and after 8 weeks.
Subjective appetite parameters (hunger, fullness, prospective food consumption, and desire to eat).
Measured by visual analog scale.The scale range is 0-100 mm and each end represent the extremes.
Measured: Change from baseline. Measured at baseline and after 8 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Sep 201912 May 2020

First posted30 Nov 2020
Study start3 Sep 2019
Primary completion12 May 2020
Study completion12 May 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Time Restricted FeedingStudies 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: Single blind
Who is masked: Outcomes assessor
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04647149
Sponsor's protocol ID: TRE_UFRGS#
Status last verified: Nov 2020
First submitted: 14 Nov 2020
Last updated: 30 Nov 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Time Restricted Feeding trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Early and Delayed Time-Restricted Eating on Body Weight and Metabolic Parameters in Adults With Overweight and Obesity
ClinicalTrials.gov ID: NCT04647149
Acronym / sponsor ID: TRE_UFRGS#
Conditions: Time Restricted Feeding, Intermittent Fasting, Obesity, Overweight and Obesity
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Federal University of Rio Grande do SulUniversity, hospital or other
Study start: 3 Sep 2019 (actual)
Primary completion: 12 May 2020 (actual)
Study completion: 12 May 2020 (actual)
First posted: 30 Nov 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Early Time-Restricted Eating	Experimental	Behavioral: Dietary Approach8-hour eating window between 08:00 and 16:00
Delayed Time-Restricted Eating	Experimental	Behavioral: Dietary Approach8-hour eating window between 12:00 and 20:00
Control	Experimental	Behavioral: Dietary Approach12-hour eating window between 08:00 and 20:00

Who may qualify

Ages: 20 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Male and female;
Body mass index (BMI) between 25 and 34.9 kg/m²;
Age between 20 and 40 years;
Not engaged in any structured exercise program;
Weight stable for ~3 months prior to the beginning of the study;

Key exclusion criteria (9 listed)

Current smoker;
Cardiometabolic diseases (dyslipidemia, diabetes, hypertension, etc);
Current treatment with medication or supplements which significantly affect the main studied variables;
Night-shift workers;
Night eating syndrome;

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
Dietary ApproachDietary approaches with energy restriction performed at different times of the day.	Behavioural	Control, Delayed Time-Restricted Eating, Early Time-Restricted Eating

Primary outcome

Insulin resistance (indices)
Time frame: Change from baseline. Measured at baseline and after 8 weeks.
Including but not limited to Homeostatic Model Assessment for Insulin Resistance (HOMA-IR).
Fasting insulin levels (µIU/mL)
Time frame: Change from baseline. Measured at baseline and after 8 weeks.
Measured by enzyme-Linked Immunosorbent Assay
Fasting glucose levels (mg/dL)
Time frame: Change from baseline. Measured at baseline and after 8 weeks.
Measured by colorimetric method
Insulin Sensitivity (indices)
Time frame: Change from baseline. Measured at baseline and after 8 weeks.
Including but not limited to the Matsuda index
Glucose tolerance
Time frame: Change from baseline. Measured at baseline and after 8 weeks.
Measured by oral glucose tolerance test (OGTT; 0,30,60,90, and 120 min)
Fasting lipid profile levels (mg/dL)
Time frame: Change from baseline. Measured at baseline and after 8 weeks.
Measured by colorimetric method

15 secondary outcomes

β cell function (indices)
Time frame: Change from baseline. Measured at baseline and after 8 weeks.
Fat Mass (kg)
Time frame: Change from baseline. Measured at baseline and after 8 weeks.
Fat Percentage (%)
Time frame: Change from baseline. Measured at baseline and after 8 weeks.
Fat Free Mass (kg)
Time frame: Change from baseline. Measured at baseline and after 8 weeks.
Body Weight (kg)
Time frame: Change from baseline. Measured at baseline and after 8 weeks.
Body Weight (kg)
Time frame: Change from baseline. Measured at baseline and after 4, and 8 weeks.
Bone Mineral Content (kg)
Time frame: Change from baseline. Measured at baseline and after 8 weeks.
Body Mass Index (kg/m^2)
Time frame: Change from baseline. Measured at baseline and after 8 weeks.
Fasting ketones (β-hydroxybutyrate) levels (mmol/L)
Time frame: Change from baseline. Measured at baseline and after 8 weeks.
Resting metabolic rate (Kcal/day)
Time frame: Change from baseline. Measured at baseline and after 8 weeks.
Substrate Oxidation (respiratory exchange ratio)
Time frame: Change from baseline. Measured at baseline and after 8 weeks.
Peak oxygen consumption (mL/min and mL/kg/min)
Time frame: Change from baseline. Measured at baseline and after 8 weeks.
Quality of sleep
Time frame: Change from baseline. Measured at baseline and after 8 weeks.
Risk of binge eating
Time frame: Change from baseline. Measured at baseline and after 8 weeks.
Subjective appetite parameters (hunger, fullness, prospective food consumption, and desire to eat).
Time frame: Change from baseline. Measured at baseline and after 8 weeks.

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 30 Nov 2020.

Related trials for Time Restricted Feeding

Recruiting
Time Restricted Eating for WeIght LoSs MainTenance-2
Weight Loss, Weight Gain
Recruiting
Intermittent Fasting Versus Carbohydrate Drinks Before Surgery
Perioperative Care, Intermittent Fasting
Active, not recruiting
Countermeasures to Circadian Misalignment
Circadian Rhythm Sleep Disorder of Shift Work Type, Metabolic Disease
Active, not recruiting
Nested Pilot Study Comparing Two Treatments to Reduce Type 2 Diabetes Risk in At-Risk Delawareans
Prediabetes
Not yet recruiting
Time-Restricted Eating and Personalized Energy-Restricted Diet in Obese Postmenopausal Women
Obesity (BMI Equal to or >30), Postmenopausal Symptoms

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.

Alvaro Reischak-Oliveira principal investigator

Federal University of Rio Grande do Sul

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Dietary Approach in people with Time Restricted Feeding and Intermittent Fasting, run by Federal University of Rio Grande do Sul 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 6 inclusion and 9 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 30 Nov 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 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?

Insulin resistance (indices) (time frame: Change from baseline. Measured at baseline and after 8 weeks.). The study lists 6 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 NCT04647149.

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 30 Nov 2020.