Caloric Restriction, Inflammation Biomarkers, Insulin Resistance, Obesity (Disorder), Time Restricted Eating
Conditions
Keywords
Time restricted eating, Insulin Resistance, Obesity, Caloric Restriction, Inflammation cytokines
Brief 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 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.
Interventions
OTHERtime restricted eating with caloric restriction
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
OTHERtime restricted eating without caloric restriction
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
OTHERCaloric restriction without Time restricted eating
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
OTHERNo time restricted eating - Normal diet
will be asked to maintain their normal diet as the second intervention arm without time restricted eating throughout the trial
Sponsors
University of Jordan
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
This open-label, 12-week randomized controlled experimental trial factorial 2X2 with a 1:1 allocation ratio
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum of TNF-α, IL-1β and IL-6 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lipid profile (LDL, HDL, TG, and cholesterol) | baseline and after 12 weeks of intervention | will be analyzed at based line and post intervention to determine the impact of dietary modification on lipid profile |
| body weight | baseline and every 2 weeks until 12 weeks of intervention | in kilograms (Using inbody 120 ) |
| Dietary intake using food records | week4, week 8, and week 12 week | — |
| Homa-IR | baseline and after 12 weeks of intervention | 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 |
| fasting insulin level | baseline and after 12 weeks of intervention | — |
| height | baseline | in centimeters, Height measuring scale - Stadiometer without shoes |
| Body composition | baseline and every 2 weeks until 12 weeks of intervention | %fat, fat in kilo grams, muscle mass in kilograms, using inbody 120 |
| Fasting blood glucose | baseline and after 12 weeks of intervention | — |
Countries
Jordan
Contacts
Primary ContactNajd Abdullah Sarayreh, PhD
Backup ContactOmar Mohammad Alkassasbeh, Master
Outcome results
None listed