NCT04245007

Brief Summary

This study is aimed to assess the different effect on fat mass between fasting (intervention) group and not fasting (control) group after 8 weeks 5:2 intermittent fasting (IF) among obese male student aged 18-25. Female students are excluded because if they do any restriction intake during their menstruation period which is a lot of blood lost, it will be a risk for them. This study is designed as non-blinding randomized control trial. Subject who adhere with less than 85 percent fasting (14 out of 16) will be dropped out from this study. Total sample in this study is 62 students which are 31 students for each group.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2020

Completed
9 days until next milestone

Study Start

First participant enrolled

January 27, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 28, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 9, 2020

Completed
Last Updated

January 28, 2020

Status Verified

January 1, 2020

Enrollment Period

2 months

First QC Date

January 18, 2020

Last Update Submit

January 26, 2020

Conditions

Keywords

obeseintermittent fastingfat massbody fat reduction

Outcome Measures

Primary Outcomes (1)

  • Fat mass

    reduction fat mass in the intervention group measured by bio-electrical impedance analysis

    8 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Subject will ask to do 5:2 intermittent fasting (2 non-consecutive days a week) within 8 weeks

Behavioral: Fasting

Control

NO INTERVENTION

Subject will prohibited from doing fasting or intake restriction within 8 weeks

Interventions

FastingBEHAVIORAL

Doing fasting 2 days a week within 8 weeks

Intervention

Eligibility Criteria

Age18 Years - 25 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • obese male student age 18-25
  • do not have experience on amputation
  • willingness to participate in the whole study by signing informed consent

You may not qualify if:

  • hypertrophy muscle students identified from body composition measurement
  • in a certain diet at the moment
  • consuming lipid-lowering drug at the moment
  • doing regular fasting (2 days a week) for 2 months before the study begin
  • suffer from chronic illness (confirmed by disease history form
  • using electronic implants, for example pacemaker or pane
  • using prostheses (artificial body part)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indonesia University

Depok, West Java, 16424, Indonesia

Location

MeSH Terms

Conditions

ObesityIntermittent Fasting

Interventions

Angptl4 protein, mouse

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFastingFeeding BehaviorBehavior

Study Officials

  • Hadiyati HF Fudla

    Indonesia University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ninik NM Mudjihartini

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master Student at Faculty of Medicine

Study Record Dates

First Submitted

January 18, 2020

First Posted

January 28, 2020

Study Start

January 27, 2020

Primary Completion

April 9, 2020

Study Completion

April 9, 2020

Last Updated

January 28, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations