- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05521945
Effect of Intermittent Fasting Among Adult Population (IF)
March 22, 2024 updated by: Zahara Ali Rizvi, University of the Punjab
Effect of Intermittent Fasting on Body Composition, Clinical Health Markers and Memory Status Among Adult Population: A Randomized Control Trial
Our study aims to assess the effects of intermittent fasting among the healthy population.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Research needs to be conducted to find the effects of intermittent fasting on humans as it might not have the same favorable effects on the memory of a human brain compared to mice.
This study will also help to assess the consequences of different intermittent fasting regimens on different individuals (based on age, sex, body mass index , memory status and physical activity etc)
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 12345
- University of the Punjab
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- BMI greater or equal to 25kg/m2.
Exclusion Criteria:
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intermittent Fasting Group
eight hours eating window and 16 hours for fasting among healthy population
|
16 hours fasting and 8 hours eating window
|
|
Placebo Comparator: Control group
Normal routine diet
|
normal diet without any customization
|
|
Active Comparator: Customized Dietary group
Customized diet plan according to participants' calorie intake and according to their respective Body Mass Index
|
The customized diet plan will be given to the participants according to their calorie intake requirements
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight(in kg)
Time Frame: three months
|
For BMI
|
three months
|
|
Height (in cm)
Time Frame: three months
|
for BMI
|
three months
|
|
Waist (in cm)
Time Frame: three months
|
for waist hip ratio
|
three months
|
|
Hip measurement(in cm)
Time Frame: three months
|
for waist hip ratio
|
three months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical Health Markers
Time Frame: three months
|
Low Density Lipid, Very Low Density Lipid, High Density Lipid, triglycerides
|
three months
|
|
blood sugar
Time Frame: three months
|
Fasting blood sugar level
|
three months
|
|
blood pressure
Time Frame: three months
|
Diastolic and systolic blood pressure
|
three months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Memory Status
Time Frame: three months
|
scoring system higher the value good will be results
|
three months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Javeria Saleem, Ph.D, University of the Punjab
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2022
Primary Completion (Actual)
August 11, 2023
Study Completion (Actual)
August 15, 2023
Study Registration Dates
First Submitted
August 10, 2022
First Submitted That Met QC Criteria
August 25, 2022
First Posted (Actual)
August 30, 2022
Study Record Updates
Last Update Posted (Actual)
March 26, 2024
Last Update Submitted That Met QC Criteria
March 22, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ZAHARA ALI RIZVI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
participants assessment report regarding intermittent fasting
IPD Sharing Time Frame
three months
IPD Sharing Access Criteria
access should be given when data entry completed
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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