NCT05521945

Brief Summary

Our study aims to assess the effects of intermittent fasting among the healthy population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

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, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 30, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2023

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2023

Completed
Last Updated

March 26, 2024

Status Verified

March 1, 2024

Enrollment Period

1.2 years

First QC Date

August 10, 2022

Last Update Submit

March 22, 2024

Conditions

Keywords

Intermittent fastingMemory statusphysical activitycustomized diet plan24- hour dietary recallMultifactorial Memory Questionnaire

Outcome Measures

Primary Outcomes (4)

  • Weight(in kg)

    For BMI

    three months

  • Height (in cm)

    for BMI

    three months

  • Waist (in cm)

    for waist hip ratio

    three months

  • Hip measurement(in cm)

    for waist hip ratio

    three months

Secondary Outcomes (3)

  • Clinical Health Markers

    three months

  • blood sugar

    three months

  • blood pressure

    three months

Other Outcomes (1)

  • Memory Status

    three months

Study Arms (3)

Intermittent Fasting Group

EXPERIMENTAL

eight hours eating window and 16 hours for fasting among healthy population

Behavioral: Intermittent Fasting

Customized Dietary group

ACTIVE COMPARATOR

Customized diet plan according to participants' calorie intake and according to their respective Body Mass Index

Behavioral: Calorie Restricted Diet

Control group

PLACEBO COMPARATOR

Normal routine diet

Behavioral: Normal dietary intake

Interventions

16 hours fasting and 8 hours eating window

Intermittent Fasting Group

The customized diet plan will be given to the participants according to their calorie intake requirements

Customized Dietary group

normal diet without any customization

Control group

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI greater or equal to 25kg/m2.

You may not qualify if:

  • not given consent having secondary or syndromic forms of obesity taking medication for weight gain or reduction undergoing bariatric surgery
  • diabetic pregnant women breastfeeding mothers chronic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of the Punjab

Lahore, Punjab Province, 12345, Pakistan

Location

Related Publications (1)

  • Rizvi ZA, Saleem J, Zeb I, Shahzad R, Kayani JA, Faryal J, Bukhari GMJ, Abdi G, Jain M. Effects of intermittent fasting on body composition, clinical health markers and memory status in the adult population: a single-blind randomised controlled trial. Nutr J. 2024 Nov 28;23(1):147. doi: 10.1186/s12937-024-01046-9.

MeSH Terms

Conditions

Intermittent FastingMotor Activity

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

FastingFeeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsEnergy IntakeDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Javeria Saleem, Ph.D

    University of the Punjab

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

August 10, 2022

First Posted

August 30, 2022

Study Start

June 1, 2022

Primary Completion

August 11, 2023

Study Completion

August 15, 2023

Last Updated

March 26, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

participants assessment report regarding intermittent fasting

Locations