Serum Fibroblast Growth Factor-21 Levels During Prolonged Fasting

Sponsor

Hacettepe University (Other)

Overall Status

Completed

CT.gov ID

NCT05792982

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fibroblast Growth Factor-21 Fasting	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 Design

Study Type:

Observational

Actual Enrollment :

12 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 1, 2017

Actual Primary Completion Date :

Jul 30, 2017

Actual Study Completion Date :

Jan 30, 2018

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 35 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hacettepe University Nutrition and Dietetics Department	Ankara		Turkey	06100

Sponsors and Collaborators

Hacettepe University

Investigators

Principal Investigator: Zeynep Goktas, PhD, Hacettepe University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zeynep Goktas, Principal Investigator, Hacettepe University

ClinicalTrials.gov Identifier:

NCT05792982

Other Study ID Numbers:

GO 17/402

First Posted:

Mar 31, 2023

Last Update Posted:

Mar 31, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Zeynep Goktas, Principal Investigator, Hacettepe University

FGF-21

Fasting

Ramadan

Study Results

No Results Posted as of Mar 31, 2023