Clinical trial NCT05792982: Serum Fibroblast Growth Factor-21 Levels During Prolonged Fasting
Official title: Fluctuations of Serum Fibroblast Growth Factor-21 Levels During Prolonged Fasting in Male Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fibroblast Growth Factor-21
Fasting
Keywords: FGF-21
Fasting
Ramadan
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2023-03-31
Enrollment: 12
Sex: MALE
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals were recruited through social media announcements. Individuals residing in Ankara, where Hacettepe University is located, were recruited.

Brief summary: The investigators hypothesized that serum FGF21 levels would increase with prolongation of the fasting period. The investigators also hypothesized that food intake and body composition would change. The study was conducted with 12 healthy male adults. A questionnaire was administered at the beginning of the study. Anthropometric measurements, dietary intake and physical activities were recorded and blood samples were taken before, during and after Ramadan.

Detailed description: The aim of this study was to determine the effects of hunger on serum Fibroblast Growth Factor 21 (FGF21) levels, nutritional status and anthropometric measurements of adult males during fasting. FGF21 is a significant protein in the process of adaption to fasting due to its effects on liver, adipose tissue, and brain. A total of 12 healthy individuals with normal body mass index, between the ages of 18 to 35 participated to this cross-sectional study. All participants provided written informed consent. Sample size determined with power analysis. A questionnaire was administered in order to determine individuals' general characteristics, nutrition habits, and smoking and alcohol habits. Anthropometric measurements, 24 hours dietary recall and physical activities were recorded and blood samples were taken four times in following periods; before Ramadan, first week of Ramadan, third week of Ramadan and two weeks after Ramadan. Serum FGF21 levels were determined by ELISA (Enzyme-Linked Immunosorbent Assay). Mean energy and nutrient intake were calculated by BEBIS (Nutrition Information System) and results were compared with Recommended Dietary Allowances (RDA). Paired samples t-test and Wilcoxon-signed rank test were used to explore differences. The study was approved by Hacettepe University Non-Interventional Clinical Research Ethics Board.

Eligibility criteria: Inclusion Criteria:

* Being healthy male,
* Being between the ages of 19-35,
* Fasting regularly during Ramadan.

Exclusion Criteria:

* Being females,
* Being younger than 19 years and older than 35 years of age,
* Having a BMI less than 18.5 kg/m2 and greater than 24.9 kg/m2,
* Having any chronic metabolic disease,
* Individuals who not fast regularly during Ramadan.

Primary outcomes:
measure: FGF-21 levels
timeFrame: 3 months
measure: Body weight
timeFrame: 3 months
measure: Body fat ratio
timeFrame: 3 months
measure: Body muscle composition
timeFrame: 3 months
measure: Dietary Intake
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University Nutrition and Dietetics Department
Study officials:
affiliation: Hacettepe University
name: Zeynep Goktas, PhD
role: PRINCIPAL_INVESTIGATOR
References: