Clinical trial NCT03532672: Early Effect of Fasting on Metabolic, Inflammatory, and Behavioral Responses in Females With and Without Obesity
Official title: A Single Arm Trial Investigating the Acute Effect of Fasting on Metabolic, Inflammatory, and Behavioral Responses in Females With and Without Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Obese
Keywords: Acute fasting
Inflammatory response
Energy Expenditure
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
First posted: 2018-05-22
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Blood glucose
timeFrame: At baseline (after overnight fasting) and end (after 10 hours of fasting during the day) of the intervention period (~12 hours)
measure: Lipid panel
timeFrame: At baseline (after overnight fasting) and end (after 10 hours of fasting during the day) of the intervention period (~12 hours)
measure: Interleukin 6
timeFrame: At baseline (after overnight fasting) and end (after 10 hours of fasting during the day) of the intervention period (~12 hours)
measure: Appetite sensations
timeFrame: At baseline (after overnight fasting) and end (after 10 hours of fasting during the day) of the intervention period (~12 hours)
measure: Mood states
timeFrame: At baseline (after overnight fasting) and end (after 10 hours of fasting during the day) of the intervention period (~12 hours)
Secondary outcomes:
measure: Gastrointestinal peptides
timeFrame: At baseline (after overnight fasting) and end (after 10 hours of fasting during the day) of the intervention period (~12 hours)
measure: Free fatty acids
timeFrame: At baseline (after overnight fasting) and end (after 10 hours of fasting during the day) of the intervention period (~12 hours)
measure: Neurotrophic factors
timeFrame: At baseline (after overnight fasting) and end (after 10 hours of fasting during the day) of the intervention period (~12 hours)
Other outcomes:
measure: High-sensitivity C-reactive protein
timeFrame: At baseline (after overnight fasting) and end (after 10 hours of fasting during the day) of the intervention period (~12 hours)
measure: Tumor necrosis factor-α
timeFrame: At baseline (after overnight fasting) and end (after 10 hours of fasting during the day) of the intervention period (~12 hours)
measure: Interleukin 8
timeFrame: At baseline (after overnight fasting) and end (after 10 hours of fasting during the day) of the intervention period (~12 hours)
measure: Interleukin 10
timeFrame: At baseline (after overnight fasting) and end (after 10 hours of fasting during the day) of the intervention period (~12 hours)
measure: Insulin
timeFrame: At baseline (after overnight fasting) and end (after 10 hours of fasting during the day) of the intervention period (~12 hours)
measure: Neutrophil/leukocyte ratio (NLR)
timeFrame: At baseline (after overnight fasting) and end (after 10 hours of fasting during the day) of the intervention period (~12 hours)
measure: Resting energy expenditure
timeFrame: At baseline (after overnight fasting) and end (after 10 hours of fasting during the day) of the intervention period (~12 hours)
Locations:
city: Belo Horizonte
country: Brazil
facility: Hospital das Clínicas da Universidade Federal de Minas Gerais
state: Minas Gerais
Study officials:
affiliation: Federal University of Minas Gerais
name: Adaliene Versiani Matos Ferreira, PhD
role: PRINCIPAL_INVESTIGATOR
References: