NCT06911918Not yet recruiting
The Effect of Time Restricted Eating on Glycemic and Proinflammatory Biomarkers Among Prediabetic Obese Jordanian Adults Aged 18-40 Years Old
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
Source: ClinicalTrials.gov · Last updated 4 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 20 Mar 2025
- Start date
- 5 Apr 2025
- Primary completion date
- Jul 2025
- Lead sponsor
- University of Jordan
- Diseases
- Obesity
- NCT number
- NCT06911918
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 5 Apr 2025 to the primary completion date, Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- previous weight loss surgery
- drug therapies that could interfere with the effectiveness of the dietary intervention (e.g., use of corticosteroids, and anti-diabetic drugs)
Other illness
- chronic diseases
Other
- pregnancy or intent to become pregnant
- breastfeeding
- diabetic type 1 and 2 individuals
- anyone physically active to reduce the influence of confounding covariates
Who the study is looking for
- 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
Age in the registry: 18 years to 40 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Najd Nutri Center Coordinator of this site? Confirm its status | Amman | Jordan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.