FastingNCT04923503
Diurnal Ramadan Fasting on Appetite Hormone and Metabolic Profile Among Lean, Obesity, Diabetics
A study testing diurnal fasting in people with Fasting and Gut Hormone, run by Universitas Diponegoro at 1 site in Indonesia.
Trial summary
Diabetes Mellitus individuals are known to have dietary rules, namely regulating the amount, type and time of eating. Ramadan fasting seems to be beneficial for people who want to reduce their weight, but it is not easy for diabetic patients. Read more about this study
- Who is it for?
- Ages 35 to 60 years
- Conditions the study is for
- Fasting, Gut Hormone
- What is being tested?
- diurnal fasting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Mar 2021to 1 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 35 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diabetics subjects: glucose fasting plasma > 200 mg/dL, with aged 35-60 years and body mass index above 25 kg/m;
- Obese subjects: body mass index above 25 kg/m2 with aged 35-60 years and waist circumference for men >90 cm, for women > 80 cm
- Lean subjects: body mass index below 23.5 kg/m2 with aged 35-60 years and waist circumference for men <90 cm, for women < 80 cm
Who cannot join
- experienced weight loss more than 10% from the actual weight in the last three months
- consumed medicine or supplement for weight loss diet, •. had the history of evidence of clinical depression, cognitive disorders, heart disease, cancer, liver or renal disease, chronic pulmonary disease, uncontrolled hypertension, physical disability, or other contraindications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Department of Nutrition Science, Medical Faculty, Universitas Diponegoro, Semarang, Indonesia
Diabetes Mellitus individuals are known to have dietary rules, namely regulating the amount, type and time of eating. Ramadan fasting seems to be beneficial for people who want to reduce their weight, but it is not easy for diabetic patients. Because of its distinctive features, Ramadhan induces changes in eating habits, calorie consumption, sleeping patterns, and daily physical activity, which may contribute to changes in hunger-satiety responses and glicemic control. Examining changes in gut hormones during Ramadan fasting may reveal whether this observance could change glucose metabolism in diabetics without triggering the undesirable effect of gluconeogenesis. The proportions of fat, protein, and carbohydrate in meals vary between outside and within Ramadan. Alterations in timing and composition meal during Ramadan lead to reduced food intake may affect gut hormones and metabolic responses. The aim of this study to determine whether the effect of Ramadan fasting differed in people with DM patients, pre-DM and healthy individuals, with respect to gut hormones, body composition, metabolic parameters, and glycemic control
Read the detailed description
The experimental study was performed during and after Ramadan fasting in 2021 (April to May) in Semarang, Indonesia. The present study was performed using the quasy-experimental method by pre-post measurement of three experimental groups (diabetics, Obese and healthy subjects) selected using the purposive sampling methods
- Conditions
- Fasting, Gut Hormone
- Being tested
- diurnal fasting
- Keywords
- gut hormones, metabolic parameters, obesity, lean, diabetics, ramadan fasting
- Medical subject headings
- Fasting, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diurnal fastingBehavioural
Also called ramadan fasting
subject conduct fasting in Ramadan for 30 days
| Study group | Role | What they receive |
|---|---|---|
| lean ramadan fasting | Experimental | conduct ramadan fasting for 30 days Receives: Behavioral: diurnal fasting |
| obese ramadan fasting | Experimental | conduct ramadan fasting for 30 days Receives: Behavioral: diurnal fasting |
| diabetics ramadan fasting | Experimental | conduct ramadan fasting for 30 days Receives: Behavioral: diurnal fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
change acylated ghrelin
Change from Baseline acyl ghrelin at 30 days taken in the lab from venous blood specimen
Measured: 30 days
change PYY
Change from Baseline PYY at 30 days taken in the lab from venous blood specimen
Measured: 30 days
change GLP-1
Change from Baseline GLP-1 at 30 days taken in the lab from venous blood specimen
Measured: 30 days
change insulin
Change from Baseline Insulin at 30 days taken in the lab from venous blood specimen
Measured: 30 days
Secondary outcomes (1)
change body weight
Change from Baseline body weight at 30 days
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start1 Mar 2021
- Primary completion12 Apr 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- three arm parallel group with 45 subjects: 1. fasting in lean group 2. fasting in obese group 3. fasting in diabetics group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Diponegoro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Etika Ratna Noer, Universitas Diponegoro
- Investigators
- Etika R Noer, Principal investigator, Diponegoro University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04923503
- Sponsor's protocol ID
- RMD
- Status last verified
- Jun 2021
- First submitted
- 6 Jun 2021
- Last updated
- 29 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: the result of this study is available to cite everyone
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Nutrition Science, Medical Faculty, Universitas Diponegoro, Semarang, Indonesia
- ClinicalTrials.gov ID
- NCT04923503
- Acronym / sponsor ID
- RMD
- Conditions
- Fasting, Gut Hormone
- Keywords
- gut hormones, metabolic parameters, obesity, lean, diabetics, ramadan fasting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Universitas DiponegoroUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 12 Apr 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 11 Jun 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.
Diabetes Mellitus individuals are known to have dietary rules, namely regulating the amount, type and time of eating. Ramadan fasting seems to be beneficial for people who want to reduce their weight, but it is not easy for diabetic patients. Because of its distinctive features, Ramadhan induces changes in eating habits, calorie consumption, sleeping patterns, and daily physical activity, which may contribute to changes in hunger-satiety responses and glicemic control. Examining changes in gut hormones during Ramadan fasting may reveal whether this observance could change glucose metabolism in diabetics without triggering the undesirable effect of gluconeogenesis. The proportions of fat, protein, and carbohydrate in meals vary between outside and within Ramadan. Alterations in timing and composition meal during Ramadan lead to reduced food intake may affect gut hormones and metabolic responses. The aim of this study to determine whether the effect of Ramadan fasting differed in people with DM patients, pre-DM and healthy individuals, with respect to gut hormones, body composition, metabolic parameters, and glycemic control
Detailed description
The experimental study was performed during and after Ramadan fasting in 2021 (April to May) in Semarang, Indonesia. The present study was performed using the quasy-experimental method by pre-post measurement of three experimental groups (diabetics, Obese and healthy subjects) selected using the purposive sampling methods
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- three arm parallel group with 45 subjects: 1. fasting in lean group 2. fasting in obese group 3. fasting in diabetics group
| Arm | Type | Receives |
|---|---|---|
| lean ramadan fasting | Experimental | Behavioral: diurnal fastingconduct ramadan fasting for 30 days |
| obese ramadan fasting | Experimental | Behavioral: diurnal fastingconduct ramadan fasting for 30 days |
| diabetics ramadan fasting | Experimental | Behavioral: diurnal fastingconduct ramadan fasting for 30 days |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diabetics subjects: glucose fasting plasma > 200 mg/dL, with aged 35-60 years and body mass index above 25 kg/m;
- Obese subjects: body mass index above 25 kg/m2 with aged 35-60 years and waist circumference for men >90 cm, for women > 80 cm
- Lean subjects: body mass index below 23.5 kg/m2 with aged 35-60 years and waist circumference for men <90 cm, for women < 80 cm
Key exclusion criteria (2 listed)
- experienced weight loss more than 10% from the actual weight in the last three months
- consumed medicine or supplement for weight loss diet, •. had the history of evidence of clinical depression, cognitive disorders, heart disease, cancer, liver or renal disease, chronic pulmonary disease, uncontrolled hypertension, physical disability, or other contraindications
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 |
|---|---|---|
| diurnal fastingAlso: ramadan fastingsubject conduct fasting in Ramadan for 30 days | Behavioural | diabetics ramadan fasting, lean ramadan fasting, obese ramadan fasting |
Primary outcome
change acylated ghrelin
Time frame: 30 days
Change from Baseline acyl ghrelin at 30 days taken in the lab from venous blood specimen
change PYY
Time frame: 30 days
Change from Baseline PYY at 30 days taken in the lab from venous blood specimen
change GLP-1
Time frame: 30 days
Change from Baseline GLP-1 at 30 days taken in the lab from venous blood specimen
change insulin
Time frame: 30 days
Change from Baseline Insulin at 30 days taken in the lab from venous blood specimen
1 secondary outcome
change body weight
Time frame: 30 days
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 29 Jun 2021.
- Individual participant dataSharing planned: Yes. the result of this study is available to cite everyone
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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.
Etika R Noer principal investigator
Diponegoro University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diurnal fasting in people with Fasting and Gut Hormone, run by Universitas Diponegoro 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 3 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 29 Jun 2021. 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?
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?
change acylated ghrelin (time frame: 30 days). 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?
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 29 Jun 2021.