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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03532672
Enrollment
54
Registered
2018-05-22
Start date
2017-09-22
Completion date
2022-12-31
Last updated
2025-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, Obese

Keywords

Acute fasting, Inflammatory response, Energy Expenditure

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.

Interventions

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.

Sponsors

Federal University of Minas Gerais
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Blood glucoseAt 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
Mood statesAt 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
Appetite sensationsAt 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
Interleukin 6At 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
Lipid panelAt 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

Secondary

MeasureTime frameDescription
Gastrointestinal peptidesAt 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
Free fatty acidsAt 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
Neurotrophic factorsAt 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

MeasureTime frameDescription
Interleukin 8At 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
Tumor necrosis factor-αAt 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
Neutrophil/leukocyte ratio (NLR)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
InsulinAt 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
Interleukin 10At 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
Resting energy expenditureAt 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
High-sensitivity C-reactive proteinAt 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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026