Serum Fibroblast Growth Factor-21 Levels During Prolonged Fasting

Fasting Clinical Trial

Official title:

Fluctuations of Serum Fibroblast Growth Factor-21 Levels During Prolonged Fasting in Male Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05792982
• Other study ID #: GO 17/402
• Status: Completed
• Start date: May 1, 2017
• Est. completion date: January 30, 2018

Study information

• Verified date: March 2023
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 30, 2018
• Est. primary completion date: July 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fasting

Intervention

Behavioral:
• 12 hour fasting for 29 days
This study aims to determine the effects of fasting on serum FGF21 levels. For this reason, male adults who fasted during the Ramadan were included in the study.

Locations

Country	Name	City	State
Turkey	Hacettepe University Nutrition and Dietetics Department	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FGF-21 levels	Blood samples were collected and serum FGF21 levels were determined by ELISA method	3 months
Primary	Body weight	Body weight was measured using a scale with 100g sensitivity.	3 months
Primary	Body fat ratio	Body fat ratio was measured by a bioelectrical impedance analysis device.	3 months
Primary	Body muscle composition	Body fat composition was measured by a bioelectrical impedance analysis device.	3 months
Primary	Dietary Intake	24-hour dietary recall questionnaires were administered by researchers.	3 months