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
Verified date | September 2023 |
Source | Federal University of Minas Gerais |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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). |
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital das Clínicas da Universidade Federal de Minas Gerais | Belo Horizonte | Minas Gerais |
Lead Sponsor | Collaborator |
---|---|
Federal University of Minas Gerais |
Brazil,
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) |
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