An Anti-inflammatory Diet Effect on Metabolic, Inflammatory and Immune Status of Obese Younger Adults
- Conditions
- Obesity
- Interventions
- Behavioral: Control energy-restricted dietBehavioral: Anti-inflammatory energy-restricted diet
- Registration Number
- NCT03987776
- Lead Sponsor
- Clinical Hospital Center Rijeka
- 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®.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 220
- adults age of 18 to 50 years
- body mass index ≥ 30 kg/m2
- with or without obesity related complications
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control energy-resticted diet Control energy-restricted diet isocaloric to anti-inflammatory diet, energy restricted diet (55-60% carbohydrates, 25% fat, 15-20% protein) used in a standard obesity management Anti-inflammatory diet Anti-inflammatory energy-restricted diet 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
- Primary Outcome Measures
Name Time Method 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 of fat mass baseline, follow up 6 months fat mass (kg) measured with bioelectric impedance analyzer
The changes in the waist circumference baseline, follow up 6 months waist circumference (cm) measured with measuring tape
The changes of visceral adipose tissue baseline, follow up 6 months visceral adipose tissue (l) 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 fat-free mass baseline, follow up 6 months fat-free mass (kg) measured with bioelectric impedance analyzer
- Secondary Outcome Measures
Name Time Method 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 thyroid stimulating hormone (TSH) concentration baseline, follow up 6 months concentration of TSH (mIU/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 free tri-iodothyronine (fT3) concentration baseline, follow up 6 months concentration of fT3 (pmol/l)
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))
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 fasting glucose concentration baseline, follow up 6 months concentration of fasting glucose (mmol/l)
The changes in HbA1c concentration baseline, follow up 6 months concentration of HbA1c (mmol/mol; %)
Trial Locations
- Locations (1)
Clinical Hospital Rijeka
🇭🇷Rijeka, Croatia