Obesity
Conditions
Keywords
anti-inflammatory diet, obesity, low-grade inflammation, cardiometabolic, immunity
Brief summary
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
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®.
Interventions
BEHAVIORALAnti-inflammatory energy-restricted diet
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.
BEHAVIORALControl energy-restricted diet
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)
Sponsors
University of Rijeka
Clinical Hospital Center Rijeka
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The changes in the body mass index | baseline, follow up 6 months | body mass index (kg/m2) calculated from measured body weight (kg) and height (m) |
| The changes in the waist circumference | baseline, follow up 6 months | waist circumference (cm) measured with measuring tape |
| The changes of fat mass | baseline, follow up 6 months | fat mass (kg) measured with bioelectric impedance analyzer |
| The changes of fat-free mass | baseline, follow up 6 months | fat-free mass (kg) measured with bioelectric impedance analyzer |
| The changes of skeletal muscle mass | baseline, follow up 6 months | skeletal muscle mass (kg) measured with bioelectric impedance analyzer |
| The changes of visceral adipose tissue | baseline, follow up 6 months | visceral adipose tissue (l) measured with bioelectric impedance analyzer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The changes in serum IL-beta, IL-6 and TNF-alpha concentrations | baseline, follow up 6 months | concentration of serum IL-1 beta (pg/ml), IL-6 (pg/ml), TNF-alpha (pg/ml) |
| The changes in serum hs-C-reactive protein concentration | baseline, follow up 6 months | concentration of serum hs-C-reactive protein (mg/l) |
| The changes of blood lymphocytes T and lymphocite subgroups count | baseline, follow up 6 months | count of blood lymphocytes T, lymphocyte subgroups (TCD3, TCD4, TCD8, BCD19, NKCs, Tregs (CD4+CD25+Foxp3+)) |
| The changes in fasting glucose concentration | baseline, follow up 6 months | concentration of fasting glucose (mmol/l) |
| The changes in free tri-iodothyronine (fT3) concentration | baseline, follow up 6 months | concentration of fT3 (pmol/l) |
| The changes in free thyroxine (fT4) concentration | baseline, follow up 6 months | concentration of fT4 (pmol/l) and thyroid peroxidase antibodies concentration (IU/l) |
| The changes in thyroid peroxidase antibodies (TPOAbs) concentration | baseline, follow up 6 months | concentration of TPOAbs (IU/l) |
| The changes in thyroid stimulating hormone (TSH) concentration | baseline, follow up 6 months | concentration of TSH (mIU/l) |
| The changes in HbA1c concentration | baseline, follow up 6 months | concentration of HbA1c (mmol/mol; %) |
| The changes in insulin concentration | baseline, follow up 6 months | concentration of insulin (mU/l) |
| The changes of HOMA-index | baseline, follow up 6 months | 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 |
| The changes in serum lipid profile | baseline, follow up 6 months | concentration of fasting triglycerides (mmol/l), HDL (mmol/l), LDL (mmol/l), total cholesterol (mmol/l) |
| The changes in serum liver transaminases concentration | baseline, follow up 6 months | concentration of serum fasting liver transaminases (AST (U/l), ALT (U/l), GGT (U/l), ALP (U/l)) |
Countries
Croatia
Outcome results
None listed