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NCT Number: NCT03574103

Chronic Effect of Fasting

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.

Recruiting

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Key information

Age range

18 year–59 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital da Clínicas, Belo Horizonte, Minas Gerais, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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 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 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.

Primary outcomes

  1. Change in body weight

    Time frame: Baseline and weeks 2, 4 and 8

    Body weight will be assessed by mechanical scale

Secondary outcomes

  1. Change in body composition

    Time frame: Baseline and weeks 2, 4 and 8

    Body composition will be assessed by electrical bioimpedance

  2. Change in resting energy expenditure

    Time frame: Baseline and weeks 2, 4 and 8

    Resting energy expenditure will be assessed by indirect calorimetry

  3. Change in self-reported energy intake

    Time frame: Baseline and weeks 2, 4 and 8

    Dietary energy intake will be assessed with 3-days food records

  4. Change in self-reported diet composition

    Time frame: Baseline and weeks 2, 4 and 8

    Dietary macronutrient intake will be assessed with 3-days food records

  5. Change in self-reported intervention adherence

    Time frame: Baseline and weeks 2, 4 and 8

    Adherence will be assessed by daily record of feeding hours

  6. Change in metabolic profile

    Time frame: Baseline and weeks 2, 4 and 8

    Fasting lipids, glucose and free fatty acids

  7. Change in self-reported stress

    Time frame: Baseline and weeks 2, 4 and 8

    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.

  8. Change in self-reported anxiety

    Time frame: Baseline and weeks 2, 4 and 8

    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.

  9. Change in self-reported depression

    Time frame: Baseline and weeks 2, 4 and 8

    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.

Other outcomes

  1. High-sensitivity C-reactive protein

    Time frame: Baseline and weeks 2, 4 and 8

    Change will be assessed in blood sample

  2. Insulin

    Time frame: Baseline and weeks 2, 4 and 8

    Change will be assessed in blood sample

  3. Leptin

    Time frame: Baseline and weeks 2, 4 and 8

    Change will be assessed in blood sample

  4. Ghrelin

    Time frame: Baseline and weeks 2, 4 and 8

    Change will be assessed in blood sample

  5. Brain-Derived Neurotrophic Factor (BDNF)

    Time frame: Baseline and weeks 2, 4 and 8

    Change will be assessed in blood sample

Study contacts

Contact information is provided by the study sponsor or research team.

Adaliene VM Ferreira, PhD

CONTACT

[email protected]

+553134093680

Sponsors and collaborators

Lead sponsor

Federal University of Minas Gerais

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2025
Study completion
2026
First posted
Jun 29, 2018
Registry last updated
Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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