ObesityNCT04319133
Effect Of Intermittent Fasting To Metabolic And Oxidative Stress Marker
A study testing Fasting in people with Obesity, run by Anni Rahmawati at 1 site in Indonesia.
Trial summary
The world prevalence of obesity in adult population in 2016 was 650 million while in Indonesia, it has increased from 14,8 percent to 21,8 percent in 2018. Obesity is an established risk factors for metabolic and non communicable- diseases. Read more about this study
- Who is it for?
- Ages 30 to 59 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Fasting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteIndonesia
- Study dates
- Jun 2020to Sep 2020
- 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 30 to 59 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men aged 30-59 years
- Has a BMI ≥ 25 kg/m^2
- Has a waist circumference of ≥ 90 cm
- Willingness to participate in the whole study by signing informed consent
Who cannot join
- Doing regular fasting (2 days a week) for 12 weeks before the study begins.
- In a certain diet at the moment
- Participants who are taking drugs that can affect blood sugar, insulin, and drugs (steroids, beta blockers, adrenergics), vitamins or herbal supplements and other drugs that affect oxidative stress.
- Participants suffering from obesity with complications such as impaired liver function, impaired kidney function, heart disease and type 2 diabetes mellitus are known through anamnesis and physical examination as well as fasting blood sugar checks.
- Participants that has a fever with temperatures> 37.5 ℃
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
PT DELAMITA BiILANO
Jakarta, 13260
Anni rahmawati
Karima yudhistina
About this study
Official title: Effect Of Intermittent Fasting 5: 2 To Waist Circumference, Insulin Resistance And Oxidative Stress Marker In Obese Workers In Jakarta
The world prevalence of obesity in adult population in 2016 was 650 million while in Indonesia, it has increased from 14,8 percent to 21,8 percent in 2018. Obesity is an established risk factors for metabolic and non communicable- diseases. The purpose of this research was to assess the different effect on waist circumference, insulin resistance and oxidative stress marker between fasting (intervention) group and not fasting (control) group after 8 weeks 5:2 intermittent fasting (IF) among obese male workers.
Read the detailed description
Intermittent fasting is eating pattern in that cycles between periods of fasting and eating. 5:2 intermittent fasting (IF) is a form of time-restricted fasting which no calories are consumed for at least 14 hours (for 4 am to 6 pm) will done in two non-consecutive days days per week, followed by ad libitum intake on the remaining days, with water restriction too.
Participants will be distributed to each group by simple randomization. This study will access the characteristic data, dietary intake and physical activity from the participants. Anthropometry and blood sample (for insulin resistance (HOMA-IR) and oxidative stress (malondialdehyde and catalase)) were taken at baseline and at the end of the study. Participants from each group will gets counseling at the second week of intervention and they will follow up to 8 weeks with control and evaluation form.
- Conditions
- Obesity
- Being tested
- Fasting
- Keywords
- obesity, intermittent fasting, insulin resistance, stress oxidative marker, waist circumference
- Medical subject headings
- Obesity, Intermittent Fasting, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FastingBehavioural
Doing fasting 2 days a week within 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | Participants will ask to do 5:2 intermittent fasting (2 non-consecutive days a week) within 8 weeks Receives: Behavioral: Fasting |
| control | No intervention | Participants will not doing fasting or intake restriction within 8 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
insulin resistance
The pathological condition in which cells fail to respond normally to the hormone insulin. Assessed based on the HOMA-IR value
Measured: 8 weeks
catalase level
Enzymatic antioxidant status of endogenous catalase in the blood, expressed in U/mg
Measured: 8 weeks
plasma malondialdehyde level
the concentration of malondialdehyde (1,3-Propanedial) in the plasma as an oxidative stress marker measured by means of Will's method expressed in nmol/ml plasma unit
Measured: 8 weeks
waist circumference
One way of anthropometry measurement to assess the visceral fat mass, so that it can evaluate the risk of metabolic disease. expressed in centimeter.
Measured: 8 weeks
Secondary outcomes (1)
mean caloric intake
the average amount of calories consumed daily by the participant which was determined from food diary and subsequent caloric contents calculation expressed in kilocalorie
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study startJun 2020 (estimated)
- Primary completionAug 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Overall, this research will run for ± 10 weeks; 1 week of preparation, 8 weeks of intervention and 1 week of evaluation of the final results of the study. This research will involve an interview, physical examination and laboratory examination. This research is a clinical trial research with interventions in the form of fasting. There will be divided into two groups: the intervention group (fasting) and the control group (not fasting). The fasting group will fast every Monday and Thursday, while the fasting group consumes daily food as usual. Both groups will be given education about balanced nutrition.
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anni Rahmawati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anni Rahmawati, Universitas Indonesia
- Investigators
- Anni Rahmawati, postgraduate, Principal investigator, Ilmu Gizi Fakultas Kedokteran Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04319133
- Sponsor's protocol ID
- 20-02-0153
- Status last verified
- Apr 2020
- First submitted
- 20 Mar 2020
- Last updated
- 10 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sutton EF, Beyl R, Early KS, Cefalu WT, Ravussin E, Peterson CM. Early Time-Restricted Feeding Improves Insulin Sensitivity, Blood Pressure, and Oxidative Stress Even without Weight Loss in Men with Prediabetes. Cell Metab. 2018 Jun 5;27(6):1212-1221.e3. doi: 10.1016/j.cmet.2018.04.010. Epub 2018 May 10.
PubMed 29754952Conley M, Le Fevre L, Haywood C, Proietto J. Is two days of intermittent energy restriction per week a feasible weight loss approach in obese males? A randomised pilot study. Nutr Diet. 2018 Feb;75(1):65-72. doi: 10.1111/1747-0080.12372. Epub 2017 Aug 9.
PubMed 28791787Witjaksono F, Prafiantini E, Rahmawati A. Effect of intermittent fasting 5:2 on body composition and nutritional intake among employees with obesity in Jakarta: a randomized clinical trial. BMC Res Notes. 2022 Oct 12;15(1):323. doi: 10.1186/s13104-022-06209-7.
PubMed 36224641
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Intermittent Fasting 5: 2 To Waist Circumference, Insulin Resistance And Oxidative Stress Marker In Obese Workers In Jakarta
- ClinicalTrials.gov ID
- NCT04319133
- Acronym / sponsor ID
- 20-02-0153
- Conditions
- Obesity
- Keywords
- obesity, intermittent fasting, insulin resistance, stress oxidative marker, waist circumference
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Anni RahmawatiUniversity, hospital or other
- Study start
- Jun 2020 (estimated)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 24 Mar 2020 (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.
The world prevalence of obesity in adult population in 2016 was 650 million while in Indonesia, it has increased from 14,8 percent to 21,8 percent in 2018. Obesity is an established risk factors for metabolic and non communicable- diseases. The purpose of this research was to assess the different effect on waist circumference, insulin resistance and oxidative stress marker between fasting (intervention) group and not fasting (control) group after 8 weeks 5:2 intermittent fasting (IF) among obese male workers.
Detailed description
Intermittent fasting is eating pattern in that cycles between periods of fasting and eating. 5:2 intermittent fasting (IF) is a form of time-restricted fasting which no calories are consumed for at least 14 hours (for 4 am to 6 pm) will done in two non-consecutive days days per week, followed by ad libitum intake on the remaining days, with water restriction too.
Participants will be distributed to each group by simple randomization. This study will access the characteristic data, dietary intake and physical activity from the participants. Anthropometry and blood sample (for insulin resistance (HOMA-IR) and oxidative stress (malondialdehyde and catalase)) were taken at baseline and at the end of the study. Participants from each group will gets counseling at the second week of intervention and they will follow up to 8 weeks with control and evaluation form.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Overall, this research will run for ± 10 weeks; 1 week of preparation, 8 weeks of intervention and 1 week of evaluation of the final results of the study. This research will involve an interview, physical examination and laboratory examination. This research is a clinical trial research with interventions in the form of fasting. There will be divided into two groups: the intervention group (fasting) and the control group (not fasting). The fasting group will fast every Monday and Thursday, while the fasting group consumes daily food as usual. Both groups will be given education about balanced nutrition.
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Behavioral: FastingParticipants will ask to do 5:2 intermittent fasting (2 non-consecutive days a week) within 8 weeks |
| control | No intervention | –Participants will not doing fasting or intake restriction within 8 weeks |
Who may qualify
- Ages
- 30 to 59 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Men aged 30-59 years
- Has a BMI ≥ 25 kg/m^2
- Has a waist circumference of ≥ 90 cm
- Willingness to participate in the whole study by signing informed consent
Key exclusion criteria (5 listed)
- Doing regular fasting (2 days a week) for 12 weeks before the study begins.
- In a certain diet at the moment
- Participants who are taking drugs that can affect blood sugar, insulin, and drugs (steroids, beta blockers, adrenergics), vitamins or herbal supplements and other drugs that affect oxidative stress.
- Participants suffering from obesity with complications such as impaired liver function, impaired kidney function, heart disease and type 2 diabetes mellitus are known through anamnesis and physical examination as well as fasting blood sugar checks.
- Participants that has a fever with temperatures> 37.5 ℃
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 |
|---|---|---|
| FastingDoing fasting 2 days a week within 8 weeks | Behavioural | intervention |
Primary outcome
insulin resistance
Time frame: 8 weeks
The pathological condition in which cells fail to respond normally to the hormone insulin. Assessed based on the HOMA-IR value
catalase level
Time frame: 8 weeks
Enzymatic antioxidant status of endogenous catalase in the blood, expressed in U/mg
plasma malondialdehyde level
Time frame: 8 weeks
the concentration of malondialdehyde (1,3-Propanedial) in the plasma as an oxidative stress marker measured by means of Will's method expressed in nmol/ml plasma unit
waist circumference
Time frame: 8 weeks
One way of anthropometry measurement to assess the visceral fat mass, so that it can evaluate the risk of metabolic disease. expressed in centimeter.
1 secondary outcome
mean caloric intake
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2020.
- Results publication: PubMed 29754952Sutton EF, Beyl R, Early KS, Cefalu WT, Ravussin E, Peterson CM. Early Time-Restricted Feeding Improves Insulin Sensitivity, Blood Pressure, and Oxidative Stress Even without Weight Loss in Men with Prediabetes. Cell Metab. 2018 Jun 5;27(6):1212-1221.e3. doi: 10.1016/j.cmet.2018.04.010. Epub 2018 May 10.
- Results publication: PubMed 28791787Conley M, Le Fevre L, Haywood C, Proietto J. Is two days of intermittent energy restriction per week a feasible weight loss approach in obese males? A randomised pilot study. Nutr Diet. 2018 Feb;75(1):65-72. doi: 10.1111/1747-0080.12372. Epub 2017 Aug 9.
- Derived from this study: PubMed 36224641Witjaksono F, Prafiantini E, Rahmawati A. Effect of intermittent fasting 5:2 on body composition and nutritional intake among employees with obesity in Jakarta: a randomized clinical trial. BMC Res Notes. 2022 Oct 12;15(1):323. doi: 10.1186/s13104-022-06209-7.
- 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.
Anni Rahmawati, postgraduate principal investigator
Ilmu Gizi Fakultas Kedokteran Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fasting in people with Obesity, run by Anni Rahmawati at 1 site in Indonesia.
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 5 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 10 Apr 2020. 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 Indonesia. 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?
Contact Anni Rahmawati, postgraduate (6285260074015, annibustami@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
insulin resistance (time frame: 8 weeks). 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 NCT04319133, which also lists 3 linked publications.
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 Apr 2020.