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NCT Number: NCT05792982

Serum Fibroblast Growth Factor-21 Levels During Prolonged Fasting

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.

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Key information

Conditions

Fibroblast Growth Factor-21 Behavior Fasting Feeding Behavior

Age range

19 year–35 year

Sex eligibility

Male

Study type

Observational

Primary location

Hacettepe University Nutrition and Dietetics Department

Ankara, 06100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. FGF-21 levels

    Time frame: 3 months

    Blood samples were collected and serum FGF21 levels were determined by ELISA method

  2. Body weight

    Time frame: 3 months

    Body weight was measured using a scale with 100g sensitivity.

  3. Body fat ratio

    Time frame: 3 months

    Body fat ratio was measured by a bioelectrical impedance analysis device.

  4. Body muscle composition

    Time frame: 3 months

    Body fat composition was measured by a bioelectrical impedance analysis device.

  5. Dietary Intake

    Time frame: 3 months

    24-hour dietary recall questionnaires were administered by researchers.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Mar 31, 2023
Registry last updated
Mar 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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