Serum Fibroblast Growth Factor-21 Levels During Prolonged Fasting

NCT05792982 | Completed

• 1 other identifier: GO 17/402
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibroblast Growth Factor-21; Fasting

Keywords

FGF-21; Fasting; Ramadan

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

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

Interventions

12 hour fasting for 29 days 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.

Fasting Adult Males

Eligibility Criteria

• Age: 19 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University Nutrition and Dietetics Department

Ankara, 06100, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples were collected.

MeSH Terms

Conditions

Fasting

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Zeynep Goktas, PhD

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 17, 2023
• First Posted: March 31, 2023
• Study Start: May 1, 2017
• Primary Completion: July 30, 2017
• Study Completion: January 30, 2018
• Last Updated: March 31, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)