Intermittent FastingNCT06261229
The Effectiveness of Intermittent Fasting and Behavioral Economics Intervention on Weight Control in Obese Patients
A study testing Intermittent fasting, Intermittent fasting + Behavioral economic and Intensive Lifestyle Modification in people with Intermittent Fasting and Weight Loss, run by Mahidol University at 1 site in Thailand.
Trial summary
This study is a parallel randomized controlled trial (RCT). To determine the effect of intermittent fasting, intermittent fasting with behavioral economics, and intensive lifestyle modification on nutritional status; the differences between HOMA-IR, body weight change, and body composition in obese people. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Intermittent Fasting, Weight Loss, Behavioral Economic
- What is being tested?
- Intermittent fasting, Intermittent fasting + Behavioral economic and Intensive Lifestyle Modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteThailand
- Study dates
- 18 Apr 2022to 30 Jun 2024
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18-65 year
- BMI start at 25.0 kg/m2 (above 24.99 kg/m2)
- Weight change less than 5% in 6-month
- Ability and willingness to provide informed consent
Who cannot join
- Pregnant women or breed feeding
- Kidney disease/ Liver disease
- Abnormal Thyroid hormone, abnormal GI function
- Postoperative bariatric surgery
- Drug control weight or reduce appetite
- Drug abuse
- Mental illness
Trial locations and contacts
1 site in 1 country.
About this study
This study is a parallel randomized controlled trial (RCT). To determine the effect of intermittent fasting, intermittent fasting with behavioral economics, and intensive lifestyle modification on nutritional status; the differences between HOMA-IR, body weight change, and body composition in obese people.
Each participant will be randomized to receive the intervention (intermittent fasting, intermittent fasting with behavioral economics, or intensive lifestyle modification.
Read more
The study protocol will be explained to the eligible participant and informed written consent will be obtained.
The total sample size will be 123 participants. Blood and urine samples will be collected at baseline and each follow-up visit including 1-month, 2-months, 6-month, and 12-months, respectively for further study to find out the mechanisms of weight loss, weight regain, and the improvement in the metabolic disease.
Read the detailed description
The investigators will collect the participant characteristics (age, gender, smoking history, comorbid diseases including history of previous stroke, myocardial infarction, angina, hypertension, dyslipidemia, T2DM, risk of osteoporosis, and all medication lists) at the first visit.
- Physiological parameters:
- Body composition will be assessed by the Bioelectrical Impedance at the first visit and at each follow-up visit (1 month, 2 months, 4 months, 6 months, 9 months, and 12 months).
- Peripheral venous blood sample (15mL: clotted blood 9mL and EDTA blood 6 mL) and urinalysis will be collected from all participants at baseline and each follow-up visit (1-month, 2-months, 6-month, and 12 months). Blood samples will be immediately centrifuged and plasma/serum will be placed in a -80 Celsius freezer until analysis (glucose, HbA1C, insulin, albumin, creatinine, uric acid, lipid profile, liver function test, kidney function test, thyroid function test, and other biochemical).
- Three questionnaires will be collected:
- Global physical activity questionnaire, sleep questionnaire, and satiety visual analog score questionnaire will be obtained at the first visit and at each follow-up visit (1 month, 2 months, 4 months, 6 months, 9 months, and 12 months).
- Nutritional status will be assessed by history, 24-hour dietary recall, 3days food record, and physical examinations at the first visit and at each follow-up visit (1 month, 2 months, 4 months, 6 months, 9 months, and 12 months).
Regarding the descriptive statistical analysis, all the data will be tested for normality. Data will be presented as Mean ± standard deviation or Median (interquartile ranges) for continuous variables and frequency (%) for binary and categorical variables. The continuous variables will be compared by using Independent samples T-test or Analysis of variance (ANOVA) followed by multiple comparisons with the Bonferroni method. Test results of categorical variables will be evaluated by Chi-square or Fisher exact test as appropriate. Results will be deemed statistically significant at a P-value < 0.05.
- Conditions
- Intermittent Fasting, Weight Loss, Behavioral Economic, Obese, HOMA-IR
- Being tested
- Intermittent fasting, Intermittent fasting + Behavioral economic, Intensive Lifestyle Modification
- Keywords
- Intermittent Fasting, behavioral economic, Obese patients, Weight control, HOMA-IR
- Medical subject headings
- Intermittent Fasting, Weight Loss, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent fastingBehavioural
The participant will consume food about/ within 8-hour per day
Intermittent fasting + Behavioral economicBehavioural
Also called Intermittent fasting + Incentives
The participant will consume food about/ within 8-hour per day. They will be received a reward as money when achieve weight loss goal or/and success doing intermittent fasting 5 days/week
Intensive Lifestyle ModificationBehavioural
Advice about nutrition knowledge, healthy eating diet, diet prescription, and exercise
| Study group | Role | What they receive |
|---|---|---|
| Intermittent fasting | Experimental | The participant will consume food about/ within 8 hours per day Receives: Behavioral: Intermittent fasting |
| Intermittent fasting + Behavioral economic | Experimental | The participant will consume food about/ within 8-hour per day. They will be rewarded as money when they achieve their weight loss goal or/and successfully do intermittent fasting 5 days/week. Receives: Behavioral: Intermittent fasting + Behavioral economic |
| Intensive Lifestyle Modification | Experimental | Advice about nutrition knowledge, healthy eating diet, diet prescription, and exercise Receives: Behavioral: Intensive Lifestyle Modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
HOMR-IR (index)
Homeostatic Model Assessment for Insulin Resistance
Measured: Change from Baseline HOMR-IR at 6 months and 12 months
Body mass index (kg/m^2)
Body weight and height will be combined to report BMI in kg/m^2
Measured: Change from Baseline Body mass index at 1 month, 2 months, 4 months, 6 months, 9 months, and 12 months
Secondary outcomes (14)
FBS (mg/dl)
Fasting blood glucose
Measured: Change from Baseline FBS (mg/dl) at 1 month, 2 months, 6 months, and 12 months
HbA1C (%)
Average blood sugar levels over the past 3 months
Measured: Change from Baseline HbA1C (%) at 1 month, 2 months, 6 months, and 12 months
Albumin (g/L)
a blood plasma protein synthesized in the liver
Measured: Change from Baseline Albumin (g/L) at 1 month, 2 months, 6 months, and 12 months
Creatinine (mg/dL)
a waste product that comes from the normal wear and tear on muscles of the body
Measured: Change from Baseline Creatinine (mg/dL) at 1 month, 2 months, 6 months, and 12 months
Alanine transaminase (ALT) U/L
ALT is commonly measured clinically as part of liver function tests
Measured: Change from Baseline Alanine transaminase (ALT) U/L at 1 month, 2 months, 6 months, and 12 months
Aspartate transaminase (AST) U/L
AST is commonly measured clinically as part of liver function tests
Measured: Change from Baseline Aspartate transaminase (AST) U/L at 1 month, 2 months, 6 months, and 12 months
Uric acid (mg/dL)
Measured: Change from Baseline Uric acid (mg/dL) at 1 month, 2 months, 6 months, and 12 months
Total cholesterol (mg/dL)
Measured: Change from Baseline Total cholesterol (mg/dL) at 1 month, 2 months, 6 months, and 12 months
HDL-C (mg/dL)
High-density lipoprotein cholesterol
Measured: Change from Baseline HDL-C (mg/dL) at 1 month, 2 months, 6 months, and 12 months
LDL-C (mg/dL)
Low-density lipoprotein cholesterol
Measured: Change from Baseline LDL-C (mg/dL) at 1 month, 2 months, 6 months, and 12 months
Triglycerides (mg/dL)
Measured: Change from Baseline Triglycerides (mg/dL) at 1 month, 2 months, 6 months, and 12 months
Blood Urea Nitrogen (BUN) (mg/dL)
Measured: Change from Baseline Blood Urea Nitrogen (BUN) (mg/dL) at 1 month, 2 months, 6 months, and 12 months
Urine albumin-creatinine ratio (UACR) (mg/g)
Measured: Change from Baseline Urine albumin-creatinine ratio (UACR) (mg/g) at 1 month, 2 months, 6 months, and 12 months
Energy from food (kilocalories)
Energy from food (kilocalories) assess by 24hour-dietary recall and 3days food record
Measured: Change from Baseline Energy from food (kilocalories) at 1 month, 2 months, 4 months, 6 months, 9 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start18 Apr 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intermittent FastingStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 123 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- Health Systems Research Institute,Thailand
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06261229
- Sponsor's protocol ID
- MURA2022/230
- Status last verified
- Apr 2024
- First submitted
- 4 Oct 2022
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Intermittent Fasting and Behavioral Economics Intervention on Weight Control in Obese Patients
- ClinicalTrials.gov ID
- NCT06261229
- Acronym / sponsor ID
- MURA2022/230
- Conditions
- Intermittent Fasting, Weight Loss, Behavioral Economic, Obese, HOMA-IR
- Keywords
- Intermittent Fasting, behavioral economic, Obese patients, Weight control, HOMA-IR
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 123 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- Health Systems Research Institute,Thailand
- Study start
- 18 Apr 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 15 Feb 2024 (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 is a parallel randomized controlled trial (RCT). To determine the effect of intermittent fasting, intermittent fasting with behavioral economics, and intensive lifestyle modification on nutritional status; the differences between HOMA-IR, body weight change, and body composition in obese people.
Each participant will be randomized to receive the intervention (intermittent fasting, intermittent fasting with behavioral economics, or intensive lifestyle modification.
The study protocol will be explained to the eligible participant and informed written consent will be obtained.
The total sample size will be 123 participants. Blood and urine samples will be collected at baseline and each follow-up visit including 1-month, 2-months, 6-month, and 12-months, respectively for further study to find out the mechanisms of weight loss, weight regain, and the improvement in the metabolic disease.
Detailed description
The investigators will collect the participant characteristics (age, gender, smoking history, comorbid diseases including history of previous stroke, myocardial infarction, angina, hypertension, dyslipidemia, T2DM, risk of osteoporosis, and all medication lists) at the first visit.
- Physiological parameters:
- Body composition will be assessed by the Bioelectrical Impedance at the first visit and at each follow-up visit (1 month, 2 months, 4 months, 6 months, 9 months, and 12 months).
- Peripheral venous blood sample (15mL: clotted blood 9mL and EDTA blood 6 mL) and urinalysis will be collected from all participants at baseline and each follow-up visit (1-month, 2-months, 6-month, and 12 months). Blood samples will be immediately centrifuged and plasma/serum will be placed in a -80 Celsius freezer until analysis (glucose, HbA1C, insulin, albumin, creatinine, uric acid, lipid profile, liver function test, kidney function test, thyroid function test, and other biochemical).
- Three questionnaires will be collected:
- Global physical activity questionnaire, sleep questionnaire, and satiety visual analog score questionnaire will be obtained at the first visit and at each follow-up visit (1 month, 2 months, 4 months, 6 months, 9 months, and 12 months).
- Nutritional status will be assessed by history, 24-hour dietary recall, 3days food record, and physical examinations at the first visit and at each follow-up visit (1 month, 2 months, 4 months, 6 months, 9 months, and 12 months).
Regarding the descriptive statistical analysis, all the data will be tested for normality. Data will be presented as Mean ± standard deviation or Median (interquartile ranges) for continuous variables and frequency (%) for binary and categorical variables. The continuous variables will be compared by using Independent samples T-test or Analysis of variance (ANOVA) followed by multiple comparisons with the Bonferroni method. Test results of categorical variables will be evaluated by Chi-square or Fisher exact test as appropriate. Results will be deemed statistically significant at a P-value < 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intermittent fasting | Experimental | Behavioral: Intermittent fastingThe participant will consume food about/ within 8 hours per day |
| Intermittent fasting + Behavioral economic | Experimental | Behavioral: Intermittent fasting + Behavioral economicThe participant will consume food about/ within 8-hour per day. They will be rewarded as money when they achieve their weight loss goal or/and successfully do intermittent fasting 5 days/week. |
| Intensive Lifestyle Modification | Experimental | Behavioral: Intensive Lifestyle ModificationAdvice about nutrition knowledge, healthy eating diet, diet prescription, and exercise |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18-65 year
- BMI start at 25.0 kg/m2 (above 24.99 kg/m2)
- Weight change less than 5% in 6-month
- Ability and willingness to provide informed consent
Key exclusion criteria (7 listed)
- Pregnant women or breed feeding
- Kidney disease/ Liver disease
- Abnormal Thyroid hormone, abnormal GI function
- Postoperative bariatric surgery
- Drug control weight or reduce appetite
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 fastingThe participant will consume food about/ within 8-hour per day | Behavioural | Intermittent fasting |
| Intermittent fasting + Behavioral economicAlso: Intermittent fasting + IncentivesThe participant will consume food about/ within 8-hour per day. They will be received a reward as money when achieve weight loss goal or/and success doing intermittent fasting 5 days/week | Behavioural | Intermittent fasting + Behavioral economic |
| Intensive Lifestyle ModificationAdvice about nutrition knowledge, healthy eating diet, diet prescription, and exercise | Behavioural | Intensive Lifestyle Modification |
Primary outcome
HOMR-IR (index)
Time frame: Change from Baseline HOMR-IR at 6 months and 12 months
Homeostatic Model Assessment for Insulin Resistance
Body mass index (kg/m^2)
Time frame: Change from Baseline Body mass index at 1 month, 2 months, 4 months, 6 months, 9 months, and 12 months
Body weight and height will be combined to report BMI in kg/m^2
14 secondary outcomes
FBS (mg/dl)
Time frame: Change from Baseline FBS (mg/dl) at 1 month, 2 months, 6 months, and 12 months
HbA1C (%)
Time frame: Change from Baseline HbA1C (%) at 1 month, 2 months, 6 months, and 12 months
Albumin (g/L)
Time frame: Change from Baseline Albumin (g/L) at 1 month, 2 months, 6 months, and 12 months
Creatinine (mg/dL)
Time frame: Change from Baseline Creatinine (mg/dL) at 1 month, 2 months, 6 months, and 12 months
Alanine transaminase (ALT) U/L
Time frame: Change from Baseline Alanine transaminase (ALT) U/L at 1 month, 2 months, 6 months, and 12 months
Aspartate transaminase (AST) U/L
Time frame: Change from Baseline Aspartate transaminase (AST) U/L at 1 month, 2 months, 6 months, and 12 months
Uric acid (mg/dL)
Time frame: Change from Baseline Uric acid (mg/dL) at 1 month, 2 months, 6 months, and 12 months
Total cholesterol (mg/dL)
Time frame: Change from Baseline Total cholesterol (mg/dL) at 1 month, 2 months, 6 months, and 12 months
HDL-C (mg/dL)
Time frame: Change from Baseline HDL-C (mg/dL) at 1 month, 2 months, 6 months, and 12 months
LDL-C (mg/dL)
Time frame: Change from Baseline LDL-C (mg/dL) at 1 month, 2 months, 6 months, and 12 months
Triglycerides (mg/dL)
Time frame: Change from Baseline Triglycerides (mg/dL) at 1 month, 2 months, 6 months, and 12 months
Blood Urea Nitrogen (BUN) (mg/dL)
Time frame: Change from Baseline Blood Urea Nitrogen (BUN) (mg/dL) at 1 month, 2 months, 6 months, and 12 months
Urine albumin-creatinine ratio (UACR) (mg/g)
Time frame: Change from Baseline Urine albumin-creatinine ratio (UACR) (mg/g) at 1 month, 2 months, 6 months, and 12 months
Energy from food (kilocalories)
Time frame: Change from Baseline Energy from food (kilocalories) at 1 month, 2 months, 4 months, 6 months, 9 months, and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- 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.
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, Intermittent fasting + Behavioral economic and Intensive Lifestyle Modification in people with Intermittent Fasting and Weight Loss, run by Mahidol University at 1 site in Thailand.
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 7 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: status not confirmed, as of the sponsor's last update on 5 Apr 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 Thailand. 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?
Results are not available in the source record.
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?
HOMR-IR (index) (time frame: Change from Baseline HOMR-IR at 6 months and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Apr 2024.