NCT03098381

Brief Summary

One of religious duties for all healthy adult Muslims is fasting during Ramadan, the ninth month of Islamic lunar calendar. In this month, Ramadan observance fasted (no food and drink) from dawn to dusk. Studies demonstrated daytime fasting may pose a positive significant effect on metabolic health. Thus, this present study aimed to determine the effect of Ramadan fasting on body composition, metabolic profile, serum leptin and adiponectin levels in healthy men.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2016

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

March 15, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 31, 2017

Completed
Last Updated

March 31, 2017

Status Verified

March 1, 2017

Enrollment Period

3 months

First QC Date

March 15, 2017

Last Update Submit

March 27, 2017

Conditions

Fasting

Outcome Measures

Primary Outcomes (1)

  • body composition

    fat mass changes after 1 month of ramadan fasting in 27 participants

    1 months

Secondary Outcomes (2)

  • Metabolic profile

    1 month

  • Serum leptin and adiponectin measurements

    1 month

Eligibility Criteria

Age19 Years - 40 Years
Sexmale(Gender-based eligibility)
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

27 healthy men (19-31 years) Muslim

You may qualify if:

  • age 19-40 years
  • Muslim men
  • fasted completely during Ramadan
  • no known of any metabolic-related diseases.

You may not qualify if:

  • any diseases
  • intake of any medication and dietary supplement
  • smoking
  • alcohol drinking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Schmidt J, Hotz HG, Foitzik T, Ryschich E, Buhr HJ, Warshaw AL, Herfarth C, Klar E. Intravenous contrast medium aggravates the impairment of pancreatic microcirculation in necrotizing pancreatitis in the rat. Ann Surg. 1995 Mar;221(3):257-64. doi: 10.1097/00000658-199503000-00007.

    PMID: 7717779BACKGROUND

Related Links

MeSH Terms

Conditions

Fasting

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Suwimol sapwarobol

    Chulalongkorn University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Program Director, Nutrition and Dietetics Program

Study Record Dates

First Submitted

March 15, 2017

First Posted

March 31, 2017

Study Start

June 1, 2016

Primary Completion

September 1, 2016

Study Completion

March 1, 2017

Last Updated

March 31, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share