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

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Obese
• Intervention / Treatment: Other: Acute Fasting

Detailed Description

Lean and obese women will fast overnight (10 hours) and will have a standardized breakfast in the morning after. The participants will also fast after that meal for more 10 hours during the daily activities.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adaliene Versiani Matos Ferreira, PhD; Phone Number: +553134093680; Email: adaliene@gmail.com
• Study Contact Backup: Name: Adaliene Versiani Matos Ferreira, adaliene@gmail.com; Phone Number: +553134093680; Email: adaliene@gmail.com

Study Locations

• Brazil
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30130-100
      • Hospital das Clinicas da Universidade Federal de Minas Gerais

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acute fasting; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resting energy expenditure	Changes in resting energy expenditure will be assessed at baseline and after 10 hours of fasting during daily activities using indirect calorimetry	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)
Free fatty acids	Changes in free fatty acids 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)
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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
High-sensitivity C-reactive protein	Changes in blood high-sensitivity C-reactive protein 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)
Tumor necrosis factor-α	Changes in tumor necrosis factor-α 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 8	Changes in blood interleukin 8 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 10	Changes in blood interleukin 10 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)
Insulin	Changes in insulin 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)
Neutrophil/leukocyte ratio (NLR)	Changes in NLR 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)

Collaborators and Investigators

• Sponsor: Federal University of Minas Gerais
• Investigators: Principal Investigator: Adaliene Versiani Matos Ferreira, PhD, Federal University of Minas Gerais

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2017
• Primary Completion (Actual): March 26, 2019
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: May 7, 2018
• First Submitted That Met QC Criteria: May 19, 2018
• First Posted (Actual): May 22, 2018

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Energy Expenditure; Inflammatory response; Acute fasting
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: Acute72774617.6.0000.5149

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No