Chronic Effect of Fasting

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.

Study Overview

• Status: Recruiting
• Conditions: Overweight and Obesity
• Intervention / Treatment: Behavioral: Caloric restriction only; Behavioral: Caloric restriction plus TRF morning; Behavioral: Caloric restriction plus TRF night

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 Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adaliene VM Ferreira, PhD; Phone Number: +553134093680; Email: adaliene@gmail.com

Study Locations

• Brazil
  • MG
    • Belo Horizonte, MG, Brazil, 30130-100
      • Recruiting
      • Hospital da Clínicas
      • Contact: Adaliene VM Ferreira, PhD; Phone Number: +553134093680; Email: adaliene@gmail.com
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30130-100
      • Recruiting
      • Hospital das Clínicas
      • Contact: Adaliene VM Ferreira, PhD; Phone Number: +553134093680; Email: adaliene@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 59 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Caloric restriction only; Participants in this group will receive a eating plan with caloric restriction as dietary weight loss strategy.	Behavioral: 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.
Experimental: Caloric restriction plus TRF morning; 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; 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.
Experimental: Caloric restriction plus TRF night; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body weight	Body weight will be assessed by mechanical scale	Baseline and weeks 2, 4 and 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body composition	Body composition will be assessed by electrical bioimpedance	Baseline and weeks 2, 4 and 8
Change in resting energy expenditure	Resting energy expenditure will be assessed by indirect calorimetry	Baseline and weeks 2, 4 and 8
Change in self-reported energy intake	Dietary energy intake will be assessed with 3-days food records	Baseline and weeks 2, 4 and 8
Change in self-reported diet composition	Dietary macronutrient intake will be assessed with 3-days food records	Baseline and weeks 2, 4 and 8
Change in self-reported intervention adherence	Adherence will be assessed by daily record of feeding hours	Baseline and weeks 2, 4 and 8
Change in metabolic profile	Fasting lipids, glucose and free fatty acids	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.	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.	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.	Baseline and weeks 2, 4 and 8

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
High-sensitivity C-reactive protein	Change will be assessed in blood sample	Baseline and weeks 2, 4 and 8
Insulin	Change will be assessed in blood sample	Baseline and weeks 2, 4 and 8
Leptin	Change will be assessed in blood sample	Baseline and weeks 2, 4 and 8
Ghrelin	Change will be assessed in blood sample	Baseline and weeks 2, 4 and 8
Brain-Derived Neurotrophic Factor (BDNF)	Change will be assessed in blood sample	Baseline and weeks 2, 4 and 8

Collaborators and Investigators

• Sponsor: Federal University of Minas Gerais

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2018
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: June 19, 2018
• First Submitted That Met QC Criteria: June 19, 2018
• First Posted (Actual): June 29, 2018

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Obesity; Overweight; Weight loss; Fasting
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Obesity; Overweight
• Other Study ID Numbers: Chronic 72774617.6.0000.5149

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No