Menu
Recruiting NCT03574103

Chronic Effect of Fasting

No phase Interventional Overweight and Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Caloric restriction only, Caloric restriction plus TRF morning, Caloric restriction plus TRF night.
Who it may be relevant to
Registry conditions: Overweight and Obesity. Basic parameters: 18 years — 59 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Comparison of Weight Loss Induced by Daily Time-Restricted Feeding Versus Daily Caloric Restriction in Women With Overweight and Obesity

Overview

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.

Interventions

  • 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.
  • 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.
  • 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.

Primary outcome measures

  • Change in body weight [Time frame: Baseline and weeks 2, 4 and 8]
Secondary outcome measures (9)
  • 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]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Brazil · 2 centers
  • Hospital da Clínicas — Belo Horizonte
  • Hospital das Clínicas — Belo Horizonte

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. PMID 33512717

Identifiers

NCT: NCT03574103 · Chronic 72774617.6.0000.5149

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗