Clinical trial

The Effect of Time Restricted Eating on Glycemic and Proinflammatory Biomarkers Among Prediabetic Obese Jordanian Adults Aged 18-40 Years Old

Opening soon · Not applicable · 1 countries · Registry ID NCT06911918

Opening soonNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 40 Years

SexAll

Healthy volunteersNot accepted

ConditionInsulin Resistance, Inflammation Biomarkers, Time Restricted Eating, Caloric Restriction, Obesity (Disorder)

Full registry criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Treatments and study arms

time restricted eating with caloric restriction

Other

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 restriction

Other

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 eating

Other

No time restricted eating - Normal diet

Other

will be asked to maintain their normal diet as the second intervention arm without time restricted eating throughout the trial

Primary outcomes

Serum of TNF-α, IL-1β and IL-6baseline 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

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Najd Nutri Center🌐 Amman, Jordan

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