Chronic Effect of Fasting

NCT03574103 | Recruiting DMC

• 1 other identifier: Chronic 72774617.6.0000.5149
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Overweight and Obesity

Keywords

Obesity; Overweight; Weight loss; Fasting

Outcome Measures

Primary Outcomes (1)

• Change in body weight

  Body weight will be assessed by mechanical scale

  Baseline and weeks 2, 4 and 8

Secondary Outcomes (9)

• Change in body composition

  Baseline and weeks 2, 4 and 8

• Change in resting energy expenditure

  Baseline and weeks 2, 4 and 8

• Change in self-reported energy intake

  Baseline and weeks 2, 4 and 8

• Change in self-reported diet composition

  Baseline and weeks 2, 4 and 8

• Change in self-reported intervention adherence

  Baseline and weeks 2, 4 and 8

Other Outcomes (5)

• High-sensitivity C-reactive protein

  Baseline and weeks 2, 4 and 8

• Insulin

  Baseline and weeks 2, 4 and 8

• Leptin

  Baseline and weeks 2, 4 and 8

Study Arms (3)

Caloric restriction only

ACTIVE COMPARATOR

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

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.

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.

Behavioral: Caloric restriction plus TRF night

Interventions

Caloric restriction only 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 only

Caloric restriction plus TRF morning 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 morning

Caloric restriction plus TRF night 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.

Caloric restriction plus TRF night

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Federal University of Minas Gerais: lead

Study Sites (2)

Hospital da Clínicas

Belo Horizonte, Minas Gerais, 30130-100, Brazil

RECRUITING

Hospital das Clínicas

Belo Horizonte, Minas Gerais, 30130-100, Brazil

RECRUITING

Related Publications (1)

• 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.

  PMID: 33512717 DERIVED

MeSH Terms

Conditions

Overweight; Obesity; Weight Loss; Fasting

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Adaliene VM Ferreira, PhD

CONTACT

+553134093680; adaliene@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: June 19, 2018
• First Posted: June 29, 2018
• Study Start: July 9, 2018
• Primary Completion: September 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 18, 2025

Record last verified: 2025-03

Locations

BR (2)