Insulin ResistanceNCT06911918
The Effect of Time Restricted Eating on Glycemic and Proinflammatory Biomarkers Among Prediabetic Obese Jordanian Adults Aged 18-40 Years Old
A study testing time restricted eating with caloric restriction, time restricted eating without caloric restriction and Caloric restriction without Time restricted eating in people with Insulin Resistance and Inflammation Biomarkers, run by University of Jordan at 1 site in Jordan.
Trial summary
Obesity, a global epidemic, significantly contributes to prediabetes, cardiovascular diseases, and other chronic diseases due to its pro-inflammatory nature. This studyl investigates the effects of time-restricted eating (TRE) with calorie restriction (CR), TRE without CR, and CR without TRE on glycemic control and… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Insulin Resistance, Inflammation Biomarkers, Time Restricted Eating
- What is being tested?
- time restricted eating with caloric restriction, time restricted eating without caloric restriction and Caloric restriction without Time restricted eating
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteJordan
- Study dates
- 5 Apr 2025to Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- IR individuals diagnosed with IR by the physicians as indicated by HOMA-IR score
- female and male, BMI ≥ 30 to 39.9 kg/m2
- age between 18 and 40 years
- stable weight for 3 months before the beginning of the study
- sedentary lifestyle
Who cannot join
- previous weight loss surgery
- pregnancy or intent to become pregnant
- breastfeeding
- chronic diseases
- drug therapies that could interfere with the effectiveness of the dietary intervention (e.g., use of corticosteroids, and anti-diabetic drugs)
- diabetic type 1 and 2 individuals
- anyone physically active to reduce the influence of confounding covariates
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Time Restricted Eating on Glycemic and Proinflammatory Biomarkers Among Prediabetic Obese Jordanian Adults Aged 18-40 Years Old: A Randomized Control Study
Obesity, a global epidemic, significantly contributes to prediabetes, cardiovascular diseases, and other chronic diseases due to its pro-inflammatory nature. This studyl investigates the effects of time-restricted eating (TRE) with calorie restriction (CR), TRE without CR, and CR without TRE on glycemic control and pro-inflammatory biomarkers among prediabetic obese Jordanian adults aged 18-40 years. The study assesses changes in pro-inflammatory biomarkers (IL-1β, TNF-α, IL-6), insulin resistance (HOMA-IR), and body composition over 12 weeks.
Participants (n=120) will be randomized into four intervention arms: (1) TRE with CR, (2) TRE without CR, (3) CR without TRE, and (4) a control group with no dietary restrictions and no TRE. Biweekly anthropometric assessments will evaluate pro-inflammatory biomarkers and biochemical measures at baseline and the end of the study. The findings will provide insights into the comparative effectiveness of TRE and CR, potentially offering a safe, cost-effective intervention to prevent obesity-induced inflammation, prediabetes, and progression to type 2 diabetes mellitus.
- Conditions
- Insulin Resistance, Inflammation Biomarkers, Time Restricted Eating, Caloric Restriction, Obesity (Disorder)
- Being tested
- time restricted eating with caloric restriction, time restricted eating without caloric restriction, Caloric restriction without Time restricted eating, No time restricted eating - Normal diet
- Keywords
- Time restricted eating, Insulin Resistance, Obesity, Caloric Restriction, Inflammation cytokines
- Medical subject headings
- Insulin Resistance, Intermittent Fasting, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
time restricted eating with caloric restrictionOther
will be asked to reduce their energy intake by 550 each day. Total energy expenditure will be calculated using the Bioelectrical impedance (BIA); Inbody 120 and multiplied by the physical activity factor and reduced by 550 kilo calories for each participant. The acceptable macronutrient distribution range (AMDR) will be 45-60% carbohydrates, 15-25% protein, and 20-30% fat of the total caloric value and fasted from 18:00 to 8:00 daily (a 14-h fast) in the 12-weeks intervention
time restricted eating without caloric restrictionOther
will be asked to maintain their normal diet to the acceptable normal distribution ranges and fast from 8:00 to 18:00. They do not need to restrict caloric intake during the feeding window
Caloric restriction without Time restricted eatingOther
will be asked to reduce their energy intake by 550 each day. Total energy expenditure will be calculated using the Bioelectrical impedance (BIA); Inbody 120 and multiplied by the physical activity factor and reduced by 550 kilo calories for each participant. The acceptable macronutrient distribution range (AMDR) will be 45-60% carbohydrates, 15-25% protein, and 20-30% fat of the total caloric value
No time restricted eating - Normal dietOther
will be asked to maintain their normal diet as the second intervention arm without time restricted eating throughout the trial
| Study group | Role | What they receive |
|---|---|---|
| 10-h Time restricted eating with caloric restriction | Experimental | Not described Receives: Other: time restricted eating with caloric restriction |
| 10-h time restricted eating without caloric restriction | Active comparator | Not described Receives: Other: time restricted eating without caloric restriction |
| caloric restriction without time restricted eating | Active comparator | Not described Receives: Other: Caloric restriction without Time restricted eating |
| No time restricted eating - normal diet | Active comparator | Not described Receives: Other: No time restricted eating - Normal diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum of TNF-α, IL-1β and IL-6
Will be measured using ELISA before and after dietary intervention to assess the impact of time restricted eating on these proinflammatory biomarkers in participants diagnosed with Insulin resistance
Measured: baseline and after 12 weeks of intervention
Secondary outcomes (8)
Homa-IR
Homa-IR will be assessed using the homeostasis model assessment (HOMA) method, which involves applying the formula [fasting glucose (mg/dL) * fasting insulin (mU/mL)/ 405] to evaluate the changes in insulin resistance over 12 weeks of intervention
Measured: baseline and after 12 weeks of intervention
Lipid profile (LDL, HDL, TG, and cholesterol)
will be analyzed at based line and post intervention to determine the impact of dietary modification on lipid profile
Measured: baseline and after 12 weeks of intervention
body weight
in kilograms (Using inbody 120 )
Measured: baseline and every 2 weeks until 12 weeks of intervention
Dietary intake using food records
Measured: week4, week 8, and week 12 week
Fasting blood glucose
Measured: baseline and after 12 weeks of intervention
fasting insulin level
Measured: baseline and after 12 weeks of intervention
height
in centimeters, Height measuring scale - Stadiometer without shoes
Measured: baseline
Body composition
%fat, fat in kilo grams, muscle mass in kilograms, using inbody 120
Measured: baseline and every 2 weeks until 12 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start5 Apr 2025 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies 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
- Randomised
- Intervention model
- Factorial
- Model description
- This open-label, 12-week randomized controlled experimental trial factorial 2X2 with a 1:1 allocation ratio
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Najd AlSarayreh, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06911918
- Sponsor's protocol ID
- 382/2025
- Status last verified
- Mar 2025
- First submitted
- 20 Mar 2025
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data IPD will not be shared due to privacy concerns and institutional polices. Data access is restricted to the research team to ensure confidentially and compliance with ethical guidelines
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Time Restricted Eating on Glycemic and Proinflammatory Biomarkers Among Prediabetic Obese Jordanian Adults Aged 18-40 Years Old: A Randomized Control Study
- ClinicalTrials.gov ID
- NCT06911918
- Acronym / sponsor ID
- 382/2025
- Conditions
- Insulin Resistance, Inflammation Biomarkers, Time Restricted Eating, Caloric Restriction, Obesity (Disorder)
- Keywords
- Time restricted eating, Insulin Resistance, Obesity, Caloric Restriction, Inflammation cytokines
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- 5 Apr 2025 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 4 Apr 2025 (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.
Obesity, a global epidemic, significantly contributes to prediabetes, cardiovascular diseases, and other chronic diseases due to its pro-inflammatory nature. This studyl investigates the effects of time-restricted eating (TRE) with calorie restriction (CR), TRE without CR, and CR without TRE on glycemic control and pro-inflammatory biomarkers among prediabetic obese Jordanian adults aged 18-40 years. The study assesses changes in pro-inflammatory biomarkers (IL-1β, TNF-α, IL-6), insulin resistance (HOMA-IR), and body composition over 12 weeks.
Participants (n=120) will be randomized into four intervention arms: (1) TRE with CR, (2) TRE without CR, (3) CR without TRE, and (4) a control group with no dietary restrictions and no TRE. Biweekly anthropometric assessments will evaluate pro-inflammatory biomarkers and biochemical measures at baseline and the end of the study. The findings will provide insights into the comparative effectiveness of TRE and CR, potentially offering a safe, cost-effective intervention to prevent obesity-induced inflammation, prediabetes, and progression to type 2 diabetes mellitus.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This open-label, 12-week randomized controlled experimental trial factorial 2X2 with a 1:1 allocation ratio
| Arm | Type | Receives |
|---|---|---|
| 10-h Time restricted eating with caloric restriction | Experimental | Other: time restricted eating with caloric restriction |
| 10-h time restricted eating without caloric restriction | Active comparator | Other: time restricted eating without caloric restriction |
| caloric restriction without time restricted eating | Active comparator | Other: Caloric restriction without Time restricted eating |
| No time restricted eating - normal diet | Active comparator | Other: No time restricted eating - Normal diet |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- IR individuals diagnosed with IR by the physicians as indicated by HOMA-IR score
- female and male, BMI ≥ 30 to 39.9 kg/m2
- age between 18 and 40 years
- stable weight for 3 months before the beginning of the study
- sedentary lifestyle
Key exclusion criteria (7 listed)
- previous weight loss surgery
- pregnancy or intent to become pregnant
- breastfeeding
- chronic diseases
- drug therapies that could interfere with the effectiveness of the dietary intervention (e.g., use of corticosteroids, and anti-diabetic drugs)
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 |
|---|---|---|
| time restricted eating with caloric restrictionwill be asked to reduce their energy intake by 550 each day. Total energy expenditure will be calculated using the Bioelectrical impedance (BIA); Inbody 120 and multiplied by the physical activity factor and reduced by 550 kilo calories for each participant. The acceptable macronutrient distribution range (AMDR) will be 45-60% carbohydrates, 15-25% protein, and 20-30% fat of the total caloric value and fasted from 18:00 to 8:00 daily (a 14-h fast) in the 12-weeks intervention | Other | 10-h Time restricted eating with caloric restriction |
| time restricted eating without caloric restrictionwill be asked to maintain their normal diet to the acceptable normal distribution ranges and fast from 8:00 to 18:00. They do not need to restrict caloric intake during the feeding window | Other | 10-h time restricted eating without caloric restriction |
| Caloric restriction without Time restricted eatingwill be asked to reduce their energy intake by 550 each day. Total energy expenditure will be calculated using the Bioelectrical impedance (BIA); Inbody 120 and multiplied by the physical activity factor and reduced by 550 kilo calories for each participant. The acceptable macronutrient distribution range (AMDR) will be 45-60% carbohydrates, 15-25% protein, and 20-30% fat of the total caloric value | Other | caloric restriction without time restricted eating |
| No time restricted eating - Normal dietwill be asked to maintain their normal diet as the second intervention arm without time restricted eating throughout the trial | Other | No time restricted eating - normal diet |
Primary outcome
Serum of TNF-α, IL-1β and IL-6
Time frame: baseline and after 12 weeks of intervention
Will be measured using ELISA before and after dietary intervention to assess the impact of time restricted eating on these proinflammatory biomarkers in participants diagnosed with Insulin resistance
8 secondary outcomes
Homa-IR
Time frame: baseline and after 12 weeks of intervention
Lipid profile (LDL, HDL, TG, and cholesterol)
Time frame: baseline and after 12 weeks of intervention
body weight
Time frame: baseline and every 2 weeks until 12 weeks of intervention
Dietary intake using food records
Time frame: week4, week 8, and week 12 week
Fasting blood glucose
Time frame: baseline and after 12 weeks of intervention
fasting insulin level
Time frame: baseline and after 12 weeks of intervention
height
Time frame: baseline
Body composition
Time frame: baseline and every 2 weeks until 12 weeks of intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Individual participant dataSharing planned: No. The individual participant data IPD will not be shared due to privacy concerns and institutional polices. Data access is restricted to the research team to ensure confidentially and compliance with ethical guidelines
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing time restricted eating with caloric restriction, time restricted eating without caloric restriction and Caloric restriction without Time restricted eating in people with Insulin Resistance and Inflammation Biomarkers, run by University of Jordan at 1 site in Jordan.
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 5 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: opening soon, as of the sponsor's last update on 4 Apr 2025. 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 Jordan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Najd Abdullah Sarayreh, PhD (+962785556000 ext. 00962, najd.nutricenter@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum of TNF-α, IL-1β and IL-6 (time frame: baseline and after 12 weeks of intervention). 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 4 Apr 2025.