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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03532672
• Other study ID #: Acute72774617.6.0000.5149
• Status: Completed
• Phase: N/A
• Start date: September 22, 2017
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2023
• Source: Federal University of Minas Gerais
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 31, 2022
• Est. primary completion date: March 26, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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).

Related Conditions & MeSH terms

• Healthy
• Obese
• Obesity

Intervention

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.

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas da Universidade Federal de Minas Gerais	Belo Horizonte	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Minas Gerais

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	Tumor necrosis factor-a	Changes in tumor necrosis factor-a 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	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)
Other	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)
Other	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)
Other	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)
Other	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)