An Anti-inflammatory Diet Effect on Metabolic, Inflammatory and Immune Status of Obese Younger Adults

Study Overview
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Brief Summary
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Diet has a major role in the etiology of obesity, and there is a growing body of evidence suggesting that a variety of dietary factors can modulate obesity-induced chronic low-grade inflammation and thus the course of obesity-related chronic non-communicable diseases. The present intervention study aims to evaluate the effect of an anti-inflammatory diet on weight loss, body composition, cardiometabolic risk factors and immune system response among young adults of the obese younger adults.

Detailed Description
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Obesity pandemic presents a major challenge to chronic disease prevention worldwide. A low-grade chronic inflammation is associated with obesity and related cardiometabolic disorders, such as cardiovascular diseases, type 2 diabetes and some type of cancers. Diet has a major role in the etiology of obesity, and there is a growing body of evidence suggesting that a variety of dietary factors can modulate obesity-induced chronic low-grade inflammation and thus the course of obesity-related chronic non-communicable diseases. The present intervention study aims to evaluate the effect of an anti-Inflammatory diet on weight loss, body composition, cardiometabolic risk factors and immune system response among younger adults. A nutritional intervention based on an energy-restricted anti-inflammatory diet will be compared with an isocaloric standard diet (55-60% carbohydrates, 25% fat, 15-20% protein). The inflammatory potential of the diet will be assessed with the Dietary Inflammatory Index®.

Official Title
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The Effect of an Anti-Inflammatory Diet on Weight Loss, Body Composition, Cardiometabolic Risk Factors and Immune System Response in Younger Adults

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Anti-inflammatory energy-restricted diet
* Behavioral: Control energy-restricted diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adults age of 18 to 50 years body mass index ≥ 30 kg/m2 with or without obesity related complications Exclusion Criteria: smoking chronic hearth, renal and/or liver diseases, active carcinoma or having carcinoma in last year anti-inflammatory and/or immunosuppressive drugs intake changing the existing medication therapy persons older than 50 years active infection and/or surgical procedure in last 3 months nutritive allergy or intolerance to any anti-inflammatory diet constituent pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The randomized controlled intervention study. A nutritional intervention will be based on an energy-restricted anti-inflammatory diet that will be compared with an isocaloric standard diet (55-60% carbohydrates, 25% fat, 15-20% protein).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anti-inflammatory diet<br>energy-reduced diet with the use of low glycemic foods, wholegrain products, legumes, colorful vegetables and fruit, nuts, seeds, marine fish, olive oil, green/black tea, and multiple spices and herbs | Behavioral: Anti-inflammatory energy-restricted diet<br>* During 6 months the participants will we asked to use recommended energy-reduced diet with anti-inflammatory properties, based on colorful vegetables and fruits, legumes, nuts, seeds, marine fish, whole-grain products, and daily use of olive oil, green/black tea, multiple spices and herbs.<br>|
| Experimental: Control energy-resticted diet<br>isocaloric to anti-inflammatory diet, energy restricted diet (55-60% carbohydrates, 25% fat, 15-20% protein) used in a standard obesity management | Behavioral: Control energy-restricted diet<br>* During 6 months the participants of control group will be asked to use recommended energy-reduced diet based on standard obesity management (55-60% carbohydrates, 25% fat, 15-20% protein)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The changes in the body mass index | body mass index (kg/m2) calculated from measured body weight (kg) and height (m) | baseline, follow up 6 months | 
| The changes in the waist circumference | waist circumference (cm) measured with measuring tape | baseline, follow up 6 months | 
| The changes of fat mass | fat mass (kg) measured with bioelectric impedance analyzer | baseline, follow up 6 months | 
| The changes of fat-free mass | fat-free mass (kg) measured with bioelectric impedance analyzer | baseline, follow up 6 months | 
| The changes of skeletal muscle mass | skeletal muscle mass (kg) measured with bioelectric impedance analyzer | baseline, follow up 6 months | 
| The changes of visceral adipose tissue | visceral adipose tissue (l) measured with bioelectric impedance analyzer | baseline, follow up 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The changes in fasting glucose concentration | concentration of fasting glucose (mmol/l) | baseline, follow up 6 months | 
| The changes in HbA1c concentration | concentration of HbA1c (mmol/mol; %) | baseline, follow up 6 months | 
| The changes in insulin concentration | concentration of insulin (mU/l) | baseline, follow up 6 months | 
| The changes of HOMA-index | concentration of insulin (pmol/l) and glucose (mmol/l) for calculation of HOMA-index: HOMA - IR = (insulin (mU/l) x glucose (mmol/l)) / 22,5 | baseline, follow up 6 months | 
| The changes in serum lipid profile | concentration of fasting triglycerides (mmol/l), HDL (mmol/l), LDL (mmol/l), total cholesterol (mmol/l) | baseline, follow up 6 months | 
| The changes in serum liver transaminases concentration | concentration of serum fasting liver transaminases (AST (U/l), ALT (U/l), GGT (U/l), ALP (U/l)) | baseline, follow up 6 months | 
| The changes in serum IL-beta, IL-6 and TNF-alpha concentrations | concentration of serum IL-1 beta (pg/ml), IL-6 (pg/ml), TNF-alpha (pg/ml) | baseline, follow up 6 months | 
| The changes in serum hs-C-reactive protein concentration | concentration of serum hs-C-reactive protein (mg/l) | baseline, follow up 6 months | 
| The changes of blood lymphocytes T and lymphocite subgroups count | count of blood lymphocytes T, lymphocyte subgroups (TCD3, TCD4, TCD8, BCD19, NKCs, Tregs (CD4+CD25+Foxp3+)) | baseline, follow up 6 months | 
| The changes in thyroid stimulating hormone (TSH) concentration | concentration of TSH (mIU/l) | baseline, follow up 6 months | 
| The changes in free tri-iodothyronine (fT3) concentration | concentration of fT3 (pmol/l) | baseline, follow up 6 months | 
| The changes in free thyroxine (fT4) concentration | concentration of fT4 (pmol/l) and thyroid peroxidase antibodies concentration (IU/l) | baseline, follow up 6 months | 
| The changes in thyroid peroxidase antibodies (TPOAbs) concentration | concentration of TPOAbs (IU/l) | baseline, follow up 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anti-inflammatory diet, obesity, low-grade inflammation, cardiometabolic, immunity