Chronic Effect of Fasting

NCT ID: NCT03574103

Last Updated: 2025-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-09

Study Completion Date

2026-12-31

Brief Summary

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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

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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

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Overweight and Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Caloric restriction only

Participants in this group will receive a eating plan with caloric restriction as dietary weight loss strategy.

Group Type ACTIVE_COMPARATOR

Caloric restriction only

Intervention Type BEHAVIORAL

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 morning

Participants in this group will receive a eating plan with caloric and time restriction as dietary weight loss strategy.

Group Type EXPERIMENTAL

Caloric restriction plus TRF morning

Intervention Type BEHAVIORAL

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 night

Participants in this group will receive a eating plan with caloric and time restriction as dietary weight loss strategy.

Group Type EXPERIMENTAL

Caloric restriction plus TRF night

Intervention Type BEHAVIORAL

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.

Interventions

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Caloric restriction only

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.

Intervention Type BEHAVIORAL

Caloric restriction plus TRF morning

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.

Intervention Type BEHAVIORAL

Caloric restriction plus TRF night

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Females;
* Aged between 18 and 59 years old;
* Body mass index equal or greater 25 kg/m²;
* Agree to sign the informed consent.

Exclusion Criteria

* 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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Federal University of Minas Gerais

OTHER

Sponsor Role lead

Responsible Party

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Adaliene Versiani M. Ferreira

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital da Clínicas

Belo Horizonte, Minas Gerais, Brazil

Site Status RECRUITING

Hospital das Clínicas

Belo Horizonte, Minas Gerais, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Adaliene VM Ferreira, PhD

Role: CONTACT

+553134093680

Facility Contacts

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Adaliene VM Ferreira, PhD

Role: primary

+553134093680

Adaliene VM Ferreira, PhD

Role: primary

+553134093680

References

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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.

Reference Type DERIVED
PMID: 33512717 (View on PubMed)

Other Identifiers

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Chronic 72774617.6.0000.5149

Identifier Type: -

Identifier Source: org_study_id

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