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

NCT03532672 | Completed DMC

• 1 other identifier: Acute72774617.6.0000.5149
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy; Obese

Keywords

Acute fasting; Inflammatory response; Energy Expenditure

Outcome Measures

Primary Outcomes (5)

• Blood glucose

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

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

• Lipid panel

  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

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

• Interleukin 6

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

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

• Appetite sensations

  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

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

• Mood states

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

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

Secondary Outcomes (3)

• Gastrointestinal peptides

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

• Free fatty acids

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

• Neurotrophic factors

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

Other Outcomes (7)

• High-sensitivity C-reactive protein

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

• Tumor necrosis factor-α

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

• Interleukin 8

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

Study Arms (1)

Acute fasting

EXPERIMENTAL

Participants will fast overnight for 10 hours (resting period), consume a santdardized breakfast, and fast during daily activities (active period) for another 10 hours.

Other: Acute Fasting

Interventions

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.

Acute fasting

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Federal University of Minas Gerais: lead

Study Sites (1)

Hospital das Clínicas da Universidade Federal de Minas Gerais

Belo Horizonte, Minas Gerais, 30130-100, Brazil

Location

Related Publications (1)

• Tibaes JRB, Fagundes GB, Martins LB, Rodrigues AMDS, Campos AC, de Souza Cordeiro LM, Teixeira AL, Ferreira AVM. Effects of a single 10-hour daytime fasting intervention on mood and appetite in female adults with and without obesity: a real-world feasibility trial. Nutr Neurosci. 2025 Nov;28(11):1372-1385. doi: 10.1080/1028415X.2025.2514490. Epub 2025 Jun 10.

  PMID: 40491423 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Adaliene Versiani Matos Ferreira, PhD

  Federal University of Minas Gerais

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Associate Professor, PhD

Study Record Dates

• First Submitted: May 7, 2018
• First Posted: May 22, 2018
• Study Start: September 22, 2017
• Primary Completion: March 26, 2019
• Study Completion: December 31, 2022
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)