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Completed

NCT Number: NCT03532672

Early Effect of Fasting on Metabolic, Inflammatory, and Behavioral Responses in Females With and Without Obesity

The aim of this study is to investigate the effect of overnight fasting versus a diurnal fasting (during daily life activities) in females with and without obesity on inflammation, neurotrophins, energy metabolism, mood, food cravings, and appetite sensations.

This study will be an acute fasting intervention.

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Key information

Conditions

Healthy Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obese Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital das Clínicas da Universidade Federal de Minas Gerais

Belo Horizonte, Minas Gerais, 30130-100, Brazil

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Body mass index between 18.5 and 24.9 kg/m² or equal or greater 35 kg/m²;
  • Able to sign the informed consent.

Exclusion criteria

  • Chronic health conditions (e.g., cancer, renal, heart or liver disorders, and autoimmune diseases), or history of thyroid alterations or use of related medications;
  • Use of corticosteroids, immunosuppressors, anti-inflammatories, hypoglycemics, medications for weight loss, or any medication known to interfere with metabolic and inflammatory processes (e.g., corticosteroids, nonsteroidal anti-inflammatory drugs);
  • Previous surgery for weight loss;
  • Inability to eat any of the components of the standardized breakfast
  • Pregnancy or breastfeeding;
  • Smokingç
  • Alcohol use (>2 doses/day).

Treatment and study plan

Acute Fasting

Other

The volunteers will fast overnight (10 hours) and breakfast will be offered (bread, butter, ham and industrialized fruit juice). The participants will fast for another 10 hours during daily activities.

Primary outcomes

  1. Blood glucose

    Time frame: At baseline (after overnight fasting) and end (after 10 hours of fasting during the day) of the intervention period (~12 hours)

    Changes in blood glucose will be assessed at baseline and after 10 hours of fasting during daily activities

  2. Lipid panel

    Time frame: At baseline (after overnight fasting) and end (after 10 hours of fasting during the day) of the intervention period (~12 hours)

    Changes in lipid panel (i.e. total cholesterol, LDL, HDL and triglycerides) will be assessed at baseline and after 10 hours of fasting during daily activities

  3. Interleukin 6

    Time frame: At baseline (after overnight fasting) and end (after 10 hours of fasting during the day) of the intervention period (~12 hours)

    Changes in blood interleukin-6 will be assessed at baseline and after 10 hours of fasting during daily activities

  4. Appetite sensations

    Time frame: At baseline (after overnight fasting) and end (after 10 hours of fasting during the day) of the intervention period (~12 hours)

    Changes in hunger, satiety, fullness, and prospective food consumption will be assessed at baseline and after 10 hours of fasting during daily activities using a 100 mm visual analogue scale

  5. Mood states

    Time frame: At baseline (after overnight fasting) and end (after 10 hours of fasting during the day) of the intervention period (~12 hours)

    Changes in anger, confusion, depression, fatigue, tension, and vigor will be assessed using the Brunel Mood Scale

Secondary outcomes

  1. Gastrointestinal peptides

    Time frame: At baseline (after overnight fasting) and end (after 10 hours of fasting during the day) of the intervention period (~12 hours)

    Changes in resting energy expenditure will be assessed at baseline and after 10 hours of fasting during daily activities using indirect calorimetry

  2. Free fatty acids

    Time frame: At baseline (after overnight fasting) and end (after 10 hours of fasting during the day) of the intervention period (~12 hours)

    Changes in free fatty acids will be assessed at baseline and after 10 hours of fasting during daily activities

  3. Neurotrophic factors

    Time frame: At baseline (after overnight fasting) and end (after 10 hours of fasting during the day) of the intervention period (~12 hours)

    Changes in brain-derived neurotrophic factor (BDNF), glial cell line-derived neurotrophic factor (GDNF), and nerve growth factor (NGF) will be assessed at baseline and after 10 hours of fasting during daily activities

Other outcomes

  1. High-sensitivity C-reactive protein

    Time frame: At baseline (after overnight fasting) and end (after 10 hours of fasting during the day) of the intervention period (~12 hours)

    Changes in blood high-sensitivity C-reactive protein will be assessed at baseline and after 10 hours of fasting during daily activities

  2. Tumor necrosis factor-α

    Time frame: At baseline (after overnight fasting) and end (after 10 hours of fasting during the day) of the intervention period (~12 hours)

    Changes in tumor necrosis factor-α will be assessed at baseline and after 10 hours of fasting during daily activities

  3. Interleukin 8

    Time frame: At baseline (after overnight fasting) and end (after 10 hours of fasting during the day) of the intervention period (~12 hours)

    Changes in blood interleukin 8 will be assessed at baseline and after 10 hours of fasting during daily activities

  4. Interleukin 10

    Time frame: At baseline (after overnight fasting) and end (after 10 hours of fasting during the day) of the intervention period (~12 hours)

    Changes in blood interleukin 10 will be assessed at baseline and after 10 hours of fasting during daily activities

  5. Insulin

    Time frame: At baseline (after overnight fasting) and end (after 10 hours of fasting during the day) of the intervention period (~12 hours)

    Changes in insulin will be assessed at baseline and after 10 hours of fasting during daily activities

  6. Neutrophil/leukocyte ratio (NLR)

    Time frame: At baseline (after overnight fasting) and end (after 10 hours of fasting during the day) of the intervention period (~12 hours)

    Changes in NLR will be assessed at baseline and after 10 hours of fasting during daily activities

  7. Resting energy expenditure

    Time frame: At baseline (after overnight fasting) and end (after 10 hours of fasting during the day) of the intervention period (~12 hours)

    Changes in resting energy expenditure will be assessed at baseline and after 10 hours of fasting during daily activities using indirect calorimetry

Sponsors and collaborators

Lead sponsor

Federal University of Minas Gerais

Other

Registry information

Official study title

A Single Arm Trial Investigating the Acute Effect of Fasting on Metabolic, Inflammatory, and Behavioral Responses in Females With and Without Obesity

Important dates

Study start
2017
Primary completion
2019
Study completion
2022
First posted
May 22, 2018
Registry last updated
Mar 21, 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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