Intermittent FastingIFNCT05521945
Effect of Intermittent Fasting Among Adult Population
A study testing Intermittent Fasting, Calorie Restricted Diet and Normal dietary intake in people with Intermittent Fasting, run by University of the Punjab at 1 site in Pakistan.
Trial summary
Our study aims to assess the effects of intermittent fasting among the healthy population. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Intermittent Fasting
- What is being tested?
- Intermittent Fasting, Calorie Restricted Diet and Normal dietary intake
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2022to 15 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI greater or equal to 25kg/m2.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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)
- Conditions
- Intermittent Fasting
- Being tested
- Intermittent Fasting, Calorie Restricted Diet, Normal dietary intake
- Keywords
- Intermittent fasting, Memory status, physical activity, customized diet plan, 24- hour dietary recall, Multifactorial Memory Questionnaire
- Medical subject headings
- Intermittent Fasting, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent FastingBehavioural
16 hours fasting and 8 hours eating window
Calorie Restricted DietBehavioural
The customized diet plan will be given to the participants according to their calorie intake requirements
Normal dietary intakeBehavioural
normal diet without any customization
| Study group | Role | What they receive |
|---|---|---|
| Intermittent Fasting Group | Experimental | eight hours eating window and 16 hours for fasting among healthy population Receives: Behavioral: Intermittent Fasting |
| Customized Dietary group | Active comparator | Customized diet plan according to participants' calorie intake and according to their respective Body Mass Index Receives: Behavioral: Calorie Restricted Diet |
| Control group | Placebo comparator | Normal routine diet Receives: Behavioral: Normal dietary intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight(in kg)
For BMI
Measured: three months
Height (in cm)
for BMI
Measured: three months
Waist (in cm)
for waist hip ratio
Measured: three months
Hip measurement(in cm)
for waist hip ratio
Measured: three months
Secondary outcomes (3)
Clinical Health Markers
Low Density Lipid, Very Low Density Lipid, High Density Lipid, triglycerides
Measured: three months
blood sugar
Fasting blood sugar level
Measured: three months
blood pressure
Diastolic and systolic blood pressure
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start1 Jun 2022
- Primary completion11 Aug 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intermittent FastingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Punjab
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zahara Ali Rizvi, University of the Punjab
- Investigators
- Javeria Saleem, Ph.D, Study director, University of the Punjab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05521945
- Sponsor's protocol ID
- ZAHARA ALI RIZVI
- Acronym
- IF
- Status last verified
- Mar 2024
- First submitted
- 10 Aug 2022
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: participants assessment report regarding intermittent fasting
Publications
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.
PubMed 39609683
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intermittent Fasting on Body Composition, Clinical Health Markers and Memory Status Among Adult Population: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05521945
- Acronym / sponsor ID
- IF / ZAHARA ALI RIZVI
- Conditions
- Intermittent Fasting
- Keywords
- Intermittent fasting, Memory status, physical activity, customized diet plan, 24- hour dietary recall, Multifactorial Memory Questionnaire
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of the PunjabUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 11 Aug 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 30 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our study aims to assess the effects of intermittent fasting among the healthy population.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intermittent Fasting Group | Experimental | Behavioral: Intermittent Fastingeight hours eating window and 16 hours for fasting among healthy population |
| Customized Dietary group | Active comparator | Behavioral: Calorie Restricted DietCustomized diet plan according to participants' calorie intake and according to their respective Body Mass Index |
| Control group | Placebo comparator | Behavioral: Normal dietary intakeNormal routine diet |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI greater or equal to 25kg/m2.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent Fasting16 hours fasting and 8 hours eating window | Behavioural | Intermittent Fasting Group |
| Calorie Restricted DietThe customized diet plan will be given to the participants according to their calorie intake requirements | Behavioural | Customized Dietary group |
| Normal dietary intakenormal diet without any customization | Behavioural | Control group |
Primary outcome
Weight(in kg)
Time frame: three months
For BMI
Height (in cm)
Time frame: three months
for BMI
Waist (in cm)
Time frame: three months
for waist hip ratio
Hip measurement(in cm)
Time frame: three months
for waist hip ratio
3 secondary outcomes
Clinical Health Markers
Time frame: three months
blood sugar
Time frame: three months
blood pressure
Time frame: three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Derived from this study: PubMed 39609683Rizvi 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.
- Individual participant dataSharing planned: No. participants assessment report regarding intermittent fasting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javeria Saleem, Ph.D study director
University of the Punjab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Fasting, Calorie Restricted Diet and Normal dietary intake in people with Intermittent Fasting, run by University of the Punjab at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight(in kg) (time frame: three months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05521945, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024.