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

Not Applicable

Completed

• Conditions: Obesity

• 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®.

Study Timeline

• Study Start: 2019-03-01
• Study First Submitted: 2019-06-10
• Study First Submitted QC: 2019-06-14
• Study First Posted: 2019-06-17
• Status Verified: 2023-02
• Primary Completion: 2023-02-07
• Study Completion: 2023-02-07
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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 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; %)
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 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 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)

Trial Locations

Locations (1)

Clinical Hospital Rijeka; 🇭🇷 Rijeka, Croatia