Intermittent FastingNCT05034653
Intermittent Fasting Among Overweight and Obese Civil Servants in Malaysia.
A study testing Intermittent Fasting and Healthy Plate in people with Intermittent Fasting and Obesity, run by Ministry of Health, Malaysia at 3 sites in Malaysia.
Trial summary
This study was a quasi-experimental study established to determine the cardio-metabolic, anthropometric, dietary intake and quality of life changes following combined Intermittent Fasting Healthy Plate and Healthy Plate interventions among overweight and obese civil servants. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Intermittent Fasting, Obesity
- What is being tested?
- Intermittent Fasting and Healthy Plate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 3 sitesMalaysia
- Study dates
- 1 Jun 2020to 5 May 2021
- 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 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- aged 19-59 years
- BMI of ≥ 23 kg/m2 (overweight or obese)
- who is ready to participate in the intervention (was assessed through readiness to participate screening)
- who can provide informed consent.
Who cannot join
- has recent involvement in weight loss program/activity (intermittent fasting/diet changes/physical activity changes or any activities that are performed constantly to reduce weight)
- suffering from any eating disorder
- was diagnosed with diabetes and hypertension (on medication) or other metabolic health disturbances such as thyroid disease, chronic kidney disease, malignancy and polycystic ovarian syndrome (PCOS)
- taking any medication or supplements that can affect study outcome
- pregnant
- has lack of capacity/language skills to independently follow the protocol were excluded from this study.
Trial locations and contacts
3 sites in 1 country.
Malaysia3 sites
Institut Latihan Kementerian Kesihatan Malaysia
Kuala Lumpur, 51000
Institute for Medical Research
Kuala Lumpur, 51000
National Institute of Health
Shah Alam, Selangor, 40170
About this study
Official title: Cardiometabolic and Anthropometric Outcomes of Intermittent Fasting Among Overweight and Obese Civil Servants in Malaysia.
This study was a quasi-experimental study established to determine the cardio-metabolic, anthropometric, dietary intake and quality of life changes following combined Intermittent Fasting Healthy Plate and Healthy Plate interventions among overweight and obese civil servants.
Read the detailed description
BACKGROUND
Overweight and obesity among adults is a growing global public health threat and an essential risk factor for various non-communicable diseases. Although it is largely preventable, the worldwide prevalence of obesity nearly tripled from 1975 and 2016 and remained increasing each year. In 2016, more than 1.9 billion adults were overweight, and 650 million were obese. If this current trend continues, it is estimated that 2.7 billion and over 1 billion adults will be overweight and obese by 2025, respectively.
Since obesity occurs due to positive energy balance in the body, the strategies of preventing and treating obesity mainly focus on dietary modification and increasing physical activity. One form of calorie restriction dietary protocol is intermittent fasting (IF), which encompasses various eating diet plans that cycle between a period of fasting and non-fasting over a defined period to create a negative energy balance, hence inducing weight loss. Studies have shown that IF is effective in reducing body weight and improving metabolic outcome. Although the effects of wet IF have been well documented, the benefits of dry IF (except for Ramadan fasting) is not clearly indicated in previous studies. Dry IF is defined as complete fasting without food and fluid intake.
As portion size is a crucial determinant of energy intake, portion control by controlling the serving size is another practical method to reduce calorie intake and promote weight loss. This portion control method has been widely practised and studied worldwide, using different portion divisions depends on the culture and eating habits. Malaysia Healthy Plate, a portion control dietary plan, was created to translate the messages in Malaysia Dietary Guideline 2010 and the Malaysia Food Pyramid 2010. It is a visual tool that emphasises the quarter-quarter-half concept that provides a quick visual technique that helps ensure the intake of food is within the recommended guideline. Specifically, Malaysia Healthy Plate is a single-meal guide that divides the plate into a quarter plate of grains or grains products, a quarter plate of fish, poultry, meat or egg, and a half plate of fruits and vegetables.
While weight losses are reported in studies of conventional IF, the adaptive phenomenon of dry IF on Monday and Thursday on cardiometabolic and anthropometric outcomes is still unclear. Similarly, although the policy of Malaysia Healthy Plate has been widely practised and publicised since 2010, the effectiveness of this eating plan in improving cardiometabolic risks and promoting weight loss is still not well documented. Thus, this study aimed to determine the cardiometabolic, anthropometric, dietary intake and quality of life changes among overweight and obese civil servants following combined Intermittent Fasting and Healthy Plate (IFHP) and Healthy Plate (HP), and to explore the participants' experience throughout the study. The investigators want to investigate whether combining dry IF and HP diet protocol will improve those parameters compared to HP alone.
METHODS
This was a mixed-method quasi-experimental study that evaluates the effectiveness of IFHP and HP among overweight and obese adults. A total of 177 participants were recruited in this study, of which 91 was allocated in the IFHP group and 86 in the HP group. The intervention comprises two phases; supervised (12 weeks) and unsupervised (12 weeks). The data collection was conducted during baseline, after the supervised phase (at week 12), and after the unsupervised phase (at week 24). For each participant, serum and whole blood were collected for analysis. Data on socio-demographic, quality of life, physical activity and dietary intake were also obtained using questionnaires during data collection.
The sample size calculation was conducted using the Power and Sample Size Program. It was followed the rules required for the comparison of two groups (10). The sample size was estimated using the level of significance (α =0.05) and power of the study (1-β=0.80), minimum suggested difference (delta) of 5% weight loss that may be achieved under this intervention and the corresponding differences between groups (SD=10%). The minimum sample size required for the study is 64 participants. By considering 40% attrition, the required sample size for each arm is 90 participants. The total number of participants required for this study is 180.
Data Management
To ascertain that the data collection and record-keeping are conducted efficiently, the Data Collection Booklet was developed and assigned to each participant of this study. This booklet consists of five sections (Socio-demographic, Quality of Life, Physical Activity, Dietary Record and Anthropometry Measurements Sections) sorted into three parts representing each point of data collection; baseline, month three and month six. This booklet was used as a data collection tool to record responses and measurements of the participant during baseline and follow-ups.
Data recorded in the booklet was then entered into a database at the end of the study. The data cleaning procedure was conducted by crosschecking all the entered data in the database and booklet and exploring the data to detect any significant outliers that possibly resulted from measurement error or data entering.
Data Analysis
Analysis was conducted using the Statistical Package of Social Science (SPSS) software version 25 (IBM Corp, NY). Data for continuous variables were presented by mean ± standard deviation (SD) or median and interquartile range (IQR) (for non-normally distributed data). For categorical variables, frequencies were calculated and presented together with percentages. Variables were compared using the independent t-test or Mann-Whitney U test for continuous variables and the Chi-squared or Fisher's exact (n≤5 in any cell) test for categorical variables. All statistical tests were two-sided and used a significance level of p <0.05. In further analysis, the repeated measures ANOVA will be used to compare the within and between groups changes of the outcomes.
- Conditions
- Intermittent Fasting, Obesity
- Being tested
- Intermittent Fasting, Healthy Plate
- Keywords
- Intermittent Fasting, Obesity, Overweight, Healthy Plate
- Medical subject headings
- Intermittent Fasting, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent FastingOther
Also called Dry Intermittent Fasting
During fasting day, no food or drink allowed from dawn to dusk
Healthy PlateOther
Also called Malaysian Healthy Plate
Quarter-quarter-half meal concept
| Study group | Role | What they receive |
|---|---|---|
| Intermittent Fasting Healthy Plate (IFHP) | Experimental | Dry fasting from dawn to dusk for two days a week (Monday and Thursday) and Healthy Plate for the rest of the week. Female participants were discouraged from fasting during their menstruation period. Receives: Other: Intermittent Fasting; Other: Healthy Plate |
| Healthy Plate | Active comparator | Practice the Healthy Plate concept in at least one meal every day Receives: Other: Healthy Plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight changes
Body weight changes measured in kilogram
Measured: Change from Baseline Body Weight at week 12
Body weight changes
Body weight changes measured in kilogram
Measured: Change from Baseline Body Weight at week 24
Body mass index (BMI) changes
Body mass index changes measured in kg/m^2 (weight in kilograms, height in meters)
Measured: Change from Baseline BMI at week 12
Body mass index (BMI) changes
Body mass index changes measured in kg/m^2 (weight in kilograms, height in meters)
Measured: Change from Baseline BMI at week 24
Waist-Hip Ratio (WHR) changes
WHR changes measured in centimeters (waist and hip circumference in centimeters)
Measured: Change from Baseline WHR at week 12
Waist-Hip Ratio (WHR) changes
WHR changes measured in centimeters (waist and hip circumference in centimeters)
Measured: Change from Baseline WHR at week 24
Body Fat Percentage changes
Body Fat Percentage changes measured in percentage
Measured: Change from Baseline Body Fat Percentage at week 12
Body Fat Percentage changes
Body Fat Percentage changes measured in percentage
Measured: Change from Baseline Body Fat Percentage at week 24
Body Fat Mass changes
Body Fat Mass changes measured in kilograms
Measured: Change from Baseline Body Fat Mass at week 12
Body Fat Mass changes
Body Fat Mass changes measured in kilograms
Measured: Change from Baseline Body Fat Mass at week 24
Fat Free Mass changes
Fat Free Mass changes measured in kilograms
Measured: Change from Baseline Body Fat Mass at week 12
Fat Free Mass changes
Fat Free Mass changes measured in kilograms
Measured: Change from Baseline Body Fat Mass at week 24
Systolic Blood Pressure changes
Systolic Blood Pressure changes measured in mmHg
Measured: Change from Baseline Systolic Blood Pressure at week 12
Systolic Blood Pressure changes
Systolic Blood Pressure changes measured in mmHg
Measured: Change from Baseline Systolic Blood Pressure at week 24
Diastolic Blood Pressure changes
Diastolic Blood Pressure changes measured in mmHg
Measured: Change from Baseline Diastolic Blood Pressure at week 12
Diastolic Blood Pressure changes
Diastolic Blood Pressure changes measured in mmHg
Measured: Change from Baseline Diastolic Blood Pressure at week 24
Fasting Blood Glucose changes
Fasting Blood Glucose changes measured in mmol/L
Measured: Change from Baseline Fasting Blood Glucose at week 12
Fasting Blood Glucose changes
Fasting Blood Glucose changes measured in mmol/L
Measured: Change from Baseline Fasting Blood Glucose at week 24
2-hour Post Prandial Blood Glucose changes
2-hour Post Prandial changes measured in mmol/L
Measured: Change from Baseline 2-hour Post Prandial at week 12
2-hour Post Prandial Blood Glucose changes
2-hour Post Prandial changes measured in mmol/L
Measured: Change from Baseline 2-hour Post Prandial at week 24
HbA1c changes
HbA1c changes measured in percentage
Measured: Change from Baseline HbA1c at week 12
HbA1c changes
HbA1c changes measured in percentage
Measured: Change from Baseline HbA1c at week 24
Fasting Total Cholesterol changes
Fasting Total Cholesterol changes measured in mmol/L
Measured: Change from Baseline Fasting Total Cholesterol at week 12
Fasting Total Cholesterol changes
Fasting Total Cholesterol changes measured in mmol/L
Measured: Change from Baseline Fasting Total Cholesterol at week 24
Fasting Triglyceride changes
Fasting Triglyceride changes measured in mmol/L
Measured: Change from Baseline Fasting Triglyceride at week 12
Fasting Triglyceride changes
Fasting Triglyceride changes measured in mmol/L
Measured: Change from Baseline Fasting Triglyceride at week 24
Fasting High-density Lipoprotein-Cholesterol (HDL-C) changes
Fasting HDL-C measured in mmol/L
Measured: Change from Baseline Fasting HDL-C at week 12
Fasting High-density Lipoprotein-Cholesterol (HDL-C) changes
Fasting HDL-C measured in mmol/L
Measured: Change from Baseline Fasting HDL-C at week 24
Fasting Low-density Lipoprotein-Cholesterol (LDL-C) changes
Fasting LDL-C measured in mmol/L
Measured: Change from Baseline Fasting LDL-C at week 12
Fasting Low-density Lipoprotein-Cholesterol (LDL-C) changes
Fasting LDL-C measured in mmol/L
Measured: Change from Baseline Fasting LDL-C at week 24
Fasting Insulin changes
Fasting Insulin measured in uU/ml
Measured: Change from Baseline Fasting Insulin at week 12
Fasting Insulin changes
Fasting Insulin measured in uU/ml
Measured: Change from Baseline Fasting Insulin at week 24
Secondary outcomes (2)
Quality of Life changes
Quality of Life score measured by Obesity and Weight-Loss Quality of Life (OWLQOL ) questionnaire
Measured: At baseline, week 12 and week 24
Dietary Intake changes
Dietary intake changes measured by Food Frequency Questionnaire (FFQ)
Measured: At baseline, week 12 and week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start1 Jun 2020
- Primary completion7 Apr 2021
- Study completion5 May 2021
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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study applying mixed study method that consists of two parts: quantitative and qualitative. The quantitative part involved allocating participants into two intervention arms; combined Intermittent Fasting and Healthy Plate (IFHP) group and Healthy Plate (HP) group, and measuring the outcomes at baseline, 3-month and 6-month. On the other hand, the qualitative part aimed to explore the facilitators and barriers that enable or admonish the success of weight loss in the IFHP group through Focused Group Discussion that was conducted at month 6.
- Masking
- None (open label)
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Malaysia
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Shazana Rifham binti Abdullah, Ministry of Health, Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05034653
- Sponsor's protocol ID
- NMRR-19-3261-51726
- Status last verified
- Sep 2021
- First submitted
- 23 Aug 2021
- Last updated
- 10 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abdullah SR, Azizul NH, Wan Mohd Zin RM, Sulaiman NS, Mustafa Khalid N, Mohd Salim Mullahi Jahn RJ, Khalil MKN, Abu Seman N, Zainal Abidin NA, Ali A, Tan YZ, Omar A, Johari MZ, Abdul Aziz NS, Baharudin A, Seman Z, Ibrahim Wong N, Md Rasip ML, Yusof HM, Md Noh MF. Cardiometabolic and Anthropometric Outcomes of Intermittent Fasting Among Civil Servants With Overweight and Obesity: Study Protocol for a Nonrandomized Controlled Trial. JMIR Res Protoc. 2022 Aug 5;11(8):e33801. doi: 10.2196/33801.
PubMed 35930331
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiometabolic and Anthropometric Outcomes of Intermittent Fasting Among Overweight and Obese Civil Servants in Malaysia.
- ClinicalTrials.gov ID
- NCT05034653
- Acronym / sponsor ID
- NMRR-19-3261-51726
- Conditions
- Intermittent Fasting, Obesity
- Keywords
- Intermittent Fasting, Obesity, Overweight, Healthy Plate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Ministry of Health, MalaysiaOther government
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 7 Apr 2021 (actual)
- Study completion
- 5 May 2021 (actual)
- First posted
- 5 Sep 2021 (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.
This study was a quasi-experimental study established to determine the cardio-metabolic, anthropometric, dietary intake and quality of life changes following combined Intermittent Fasting Healthy Plate and Healthy Plate interventions among overweight and obese civil servants.
Detailed description
BACKGROUND
Overweight and obesity among adults is a growing global public health threat and an essential risk factor for various non-communicable diseases. Although it is largely preventable, the worldwide prevalence of obesity nearly tripled from 1975 and 2016 and remained increasing each year. In 2016, more than 1.9 billion adults were overweight, and 650 million were obese. If this current trend continues, it is estimated that 2.7 billion and over 1 billion adults will be overweight and obese by 2025, respectively.
Since obesity occurs due to positive energy balance in the body, the strategies of preventing and treating obesity mainly focus on dietary modification and increasing physical activity. One form of calorie restriction dietary protocol is intermittent fasting (IF), which encompasses various eating diet plans that cycle between a period of fasting and non-fasting over a defined period to create a negative energy balance, hence inducing weight loss. Studies have shown that IF is effective in reducing body weight and improving metabolic outcome. Although the effects of wet IF have been well documented, the benefits of dry IF (except for Ramadan fasting) is not clearly indicated in previous studies. Dry IF is defined as complete fasting without food and fluid intake.
As portion size is a crucial determinant of energy intake, portion control by controlling the serving size is another practical method to reduce calorie intake and promote weight loss. This portion control method has been widely practised and studied worldwide, using different portion divisions depends on the culture and eating habits. Malaysia Healthy Plate, a portion control dietary plan, was created to translate the messages in Malaysia Dietary Guideline 2010 and the Malaysia Food Pyramid 2010. It is a visual tool that emphasises the quarter-quarter-half concept that provides a quick visual technique that helps ensure the intake of food is within the recommended guideline. Specifically, Malaysia Healthy Plate is a single-meal guide that divides the plate into a quarter plate of grains or grains products, a quarter plate of fish, poultry, meat or egg, and a half plate of fruits and vegetables.
While weight losses are reported in studies of conventional IF, the adaptive phenomenon of dry IF on Monday and Thursday on cardiometabolic and anthropometric outcomes is still unclear. Similarly, although the policy of Malaysia Healthy Plate has been widely practised and publicised since 2010, the effectiveness of this eating plan in improving cardiometabolic risks and promoting weight loss is still not well documented. Thus, this study aimed to determine the cardiometabolic, anthropometric, dietary intake and quality of life changes among overweight and obese civil servants following combined Intermittent Fasting and Healthy Plate (IFHP) and Healthy Plate (HP), and to explore the participants' experience throughout the study. The investigators want to investigate whether combining dry IF and HP diet protocol will improve those parameters compared to HP alone.
METHODS
This was a mixed-method quasi-experimental study that evaluates the effectiveness of IFHP and HP among overweight and obese adults. A total of 177 participants were recruited in this study, of which 91 was allocated in the IFHP group and 86 in the HP group. The intervention comprises two phases; supervised (12 weeks) and unsupervised (12 weeks). The data collection was conducted during baseline, after the supervised phase (at week 12), and after the unsupervised phase (at week 24). For each participant, serum and whole blood were collected for analysis. Data on socio-demographic, quality of life, physical activity and dietary intake were also obtained using questionnaires during data collection.
The sample size calculation was conducted using the Power and Sample Size Program. It was followed the rules required for the comparison of two groups (10). The sample size was estimated using the level of significance (α =0.05) and power of the study (1-β=0.80), minimum suggested difference (delta) of 5% weight loss that may be achieved under this intervention and the corresponding differences between groups (SD=10%). The minimum sample size required for the study is 64 participants. By considering 40% attrition, the required sample size for each arm is 90 participants. The total number of participants required for this study is 180.
Data Management
To ascertain that the data collection and record-keeping are conducted efficiently, the Data Collection Booklet was developed and assigned to each participant of this study. This booklet consists of five sections (Socio-demographic, Quality of Life, Physical Activity, Dietary Record and Anthropometry Measurements Sections) sorted into three parts representing each point of data collection; baseline, month three and month six. This booklet was used as a data collection tool to record responses and measurements of the participant during baseline and follow-ups.
Data recorded in the booklet was then entered into a database at the end of the study. The data cleaning procedure was conducted by crosschecking all the entered data in the database and booklet and exploring the data to detect any significant outliers that possibly resulted from measurement error or data entering.
Data Analysis
Analysis was conducted using the Statistical Package of Social Science (SPSS) software version 25 (IBM Corp, NY). Data for continuous variables were presented by mean ± standard deviation (SD) or median and interquartile range (IQR) (for non-normally distributed data). For categorical variables, frequencies were calculated and presented together with percentages. Variables were compared using the independent t-test or Mann-Whitney U test for continuous variables and the Chi-squared or Fisher's exact (n≤5 in any cell) test for categorical variables. All statistical tests were two-sided and used a significance level of p <0.05. In further analysis, the repeated measures ANOVA will be used to compare the within and between groups changes of the outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study applying mixed study method that consists of two parts: quantitative and qualitative. The quantitative part involved allocating participants into two intervention arms; combined Intermittent Fasting and Healthy Plate (IFHP) group and Healthy Plate (HP) group, and measuring the outcomes at baseline, 3-month and 6-month. On the other hand, the qualitative part aimed to explore the facilitators and barriers that enable or admonish the success of weight loss in the IFHP group through Focused Group Discussion that was conducted at month 6.
| Arm | Type | Receives |
|---|---|---|
| Intermittent Fasting Healthy Plate (IFHP) | Experimental | Other: Intermittent Fasting, Other: Healthy PlateDry fasting from dawn to dusk for two days a week (Monday and Thursday) and Healthy Plate for the rest of the week. Female participants were discouraged from fasting during their menstruation period. |
| Healthy Plate | Active comparator | Other: Healthy PlatePractice the Healthy Plate concept in at least one meal every day |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- aged 19-59 years
- BMI of ≥ 23 kg/m2 (overweight or obese)
- who is ready to participate in the intervention (was assessed through readiness to participate screening)
- who can provide informed consent.
Key exclusion criteria (6 listed)
- has recent involvement in weight loss program/activity (intermittent fasting/diet changes/physical activity changes or any activities that are performed constantly to reduce weight)
- suffering from any eating disorder
- was diagnosed with diabetes and hypertension (on medication) or other metabolic health disturbances such as thyroid disease, chronic kidney disease, malignancy and polycystic ovarian syndrome (PCOS)
- taking any medication or supplements that can affect study outcome
- pregnant
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 FastingAlso: Dry Intermittent FastingDuring fasting day, no food or drink allowed from dawn to dusk | Other | Intermittent Fasting Healthy Plate (IFHP) |
| Healthy PlateAlso: Malaysian Healthy PlateQuarter-quarter-half meal concept | Other | Healthy Plate, Intermittent Fasting Healthy Plate (IFHP) |
Primary outcome
Body weight changes
Time frame: Change from Baseline Body Weight at week 12
Body weight changes measured in kilogram
Body weight changes
Time frame: Change from Baseline Body Weight at week 24
Body weight changes measured in kilogram
Body mass index (BMI) changes
Time frame: Change from Baseline BMI at week 12
Body mass index changes measured in kg/m^2 (weight in kilograms, height in meters)
Body mass index (BMI) changes
Time frame: Change from Baseline BMI at week 24
Body mass index changes measured in kg/m^2 (weight in kilograms, height in meters)
Waist-Hip Ratio (WHR) changes
Time frame: Change from Baseline WHR at week 12
WHR changes measured in centimeters (waist and hip circumference in centimeters)
Waist-Hip Ratio (WHR) changes
Time frame: Change from Baseline WHR at week 24
WHR changes measured in centimeters (waist and hip circumference in centimeters)
Body Fat Percentage changes
Time frame: Change from Baseline Body Fat Percentage at week 12
Body Fat Percentage changes measured in percentage
Body Fat Percentage changes
Time frame: Change from Baseline Body Fat Percentage at week 24
Body Fat Percentage changes measured in percentage
Body Fat Mass changes
Time frame: Change from Baseline Body Fat Mass at week 12
Body Fat Mass changes measured in kilograms
Body Fat Mass changes
Time frame: Change from Baseline Body Fat Mass at week 24
Body Fat Mass changes measured in kilograms
Fat Free Mass changes
Time frame: Change from Baseline Body Fat Mass at week 12
Fat Free Mass changes measured in kilograms
Fat Free Mass changes
Time frame: Change from Baseline Body Fat Mass at week 24
Fat Free Mass changes measured in kilograms
Systolic Blood Pressure changes
Time frame: Change from Baseline Systolic Blood Pressure at week 12
Systolic Blood Pressure changes measured in mmHg
Systolic Blood Pressure changes
Time frame: Change from Baseline Systolic Blood Pressure at week 24
Systolic Blood Pressure changes measured in mmHg
Diastolic Blood Pressure changes
Time frame: Change from Baseline Diastolic Blood Pressure at week 12
Diastolic Blood Pressure changes measured in mmHg
Diastolic Blood Pressure changes
Time frame: Change from Baseline Diastolic Blood Pressure at week 24
Diastolic Blood Pressure changes measured in mmHg
Fasting Blood Glucose changes
Time frame: Change from Baseline Fasting Blood Glucose at week 12
Fasting Blood Glucose changes measured in mmol/L
Fasting Blood Glucose changes
Time frame: Change from Baseline Fasting Blood Glucose at week 24
Fasting Blood Glucose changes measured in mmol/L
2-hour Post Prandial Blood Glucose changes
Time frame: Change from Baseline 2-hour Post Prandial at week 12
2-hour Post Prandial changes measured in mmol/L
2-hour Post Prandial Blood Glucose changes
Time frame: Change from Baseline 2-hour Post Prandial at week 24
2-hour Post Prandial changes measured in mmol/L
HbA1c changes
Time frame: Change from Baseline HbA1c at week 12
HbA1c changes measured in percentage
HbA1c changes
Time frame: Change from Baseline HbA1c at week 24
HbA1c changes measured in percentage
Fasting Total Cholesterol changes
Time frame: Change from Baseline Fasting Total Cholesterol at week 12
Fasting Total Cholesterol changes measured in mmol/L
Fasting Total Cholesterol changes
Time frame: Change from Baseline Fasting Total Cholesterol at week 24
Fasting Total Cholesterol changes measured in mmol/L
Fasting Triglyceride changes
Time frame: Change from Baseline Fasting Triglyceride at week 12
Fasting Triglyceride changes measured in mmol/L
Fasting Triglyceride changes
Time frame: Change from Baseline Fasting Triglyceride at week 24
Fasting Triglyceride changes measured in mmol/L
Fasting High-density Lipoprotein-Cholesterol (HDL-C) changes
Time frame: Change from Baseline Fasting HDL-C at week 12
Fasting HDL-C measured in mmol/L
Fasting High-density Lipoprotein-Cholesterol (HDL-C) changes
Time frame: Change from Baseline Fasting HDL-C at week 24
Fasting HDL-C measured in mmol/L
Fasting Low-density Lipoprotein-Cholesterol (LDL-C) changes
Time frame: Change from Baseline Fasting LDL-C at week 12
Fasting LDL-C measured in mmol/L
Fasting Low-density Lipoprotein-Cholesterol (LDL-C) changes
Time frame: Change from Baseline Fasting LDL-C at week 24
Fasting LDL-C measured in mmol/L
Fasting Insulin changes
Time frame: Change from Baseline Fasting Insulin at week 12
Fasting Insulin measured in uU/ml
Fasting Insulin changes
Time frame: Change from Baseline Fasting Insulin at week 24
Fasting Insulin measured in uU/ml
2 secondary outcomes
Quality of Life changes
Time frame: At baseline, week 12 and week 24
Dietary Intake changes
Time frame: At baseline, week 12 and week 24
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 10 Sep 2021.
- Derived from this study: PubMed 35930331Abdullah SR, Azizul NH, Wan Mohd Zin RM, Sulaiman NS, Mustafa Khalid N, Mohd Salim Mullahi Jahn RJ, Khalil MKN, Abu Seman N, Zainal Abidin NA, Ali A, Tan YZ, Omar A, Johari MZ, Abdul Aziz NS, Baharudin A, Seman Z, Ibrahim Wong N, Md Rasip ML, Yusof HM, Md Noh MF. Cardiometabolic and Anthropometric Outcomes of Intermittent Fasting Among Civil Servants With Overweight and Obesity: Study Protocol for a Nonrandomized Controlled Trial. JMIR Res Protoc. 2022 Aug 5;11(8):e33801. doi: 10.2196/33801.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Fasting and Healthy Plate in people with Intermittent Fasting and Obesity, run by Ministry of Health, Malaysia at 3 sites in Malaysia.
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 4 inclusion and 6 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 10 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Malaysia. 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. 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?
Body weight changes (time frame: Change from Baseline Body Weight at week 12). The study lists 32 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 NCT05034653, 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 10 Sep 2021.