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Serum Fibroblast Growth Factor-21 Levels During Prolonged Fasting

NCT ID: NCT05792982

Last Updated: 2023-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-01

Study Completion Date

2018-01-30

Brief Summary

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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

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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.

Conditions

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Fibroblast Growth Factor-21 Fasting

Keywords

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FGF-21 Fasting Ramadan

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

12 hour fasting for 29 days

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Zeynep Goktas

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zeynep Goktas, PhD

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Locations

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Hacettepe University Nutrition and Dietetics Department

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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GO 17/402

Identifier Type: -

Identifier Source: org_study_id