Serum Fibroblast Growth Factor-21 Levels During Prolonged Fasting

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

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.

Study Overview

• Status: Completed
• Conditions: Fasting; Fibroblast Growth Factor-21
• Intervention / Treatment: Behavioral: 12 hour fasting for 29 days

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.

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06100
    • Hacettepe University Nutrition and Dietetics Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

Individuals were recruited through social media announcements. Individuals residing in Ankara, where Hacettepe University is located, were recruited.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Fasting Adult Males; 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.

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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hacettepe University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): July 30, 2017
• Study Completion (Actual): January 30, 2018

Study Registration Dates

• First Submitted: March 17, 2023
• First Submitted That Met QC Criteria: March 29, 2023
• First Posted (Actual): March 31, 2023

Study Record Updates

• Last Update Posted (Actual): March 31, 2023
• Last Update Submitted That Met QC Criteria: March 29, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Fasting; Ramadan; FGF-21
• Other Study ID Numbers: GO 17/402

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