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

Sponsor

Clinical Hospital Center Rijeka (Other)

Overall Status

Recruiting

CT.gov ID

NCT03987776

Collaborator

University of Rijeka (Other)

220

Enrollment

Location

Arms

30.1

Anticipated Duration (Months)

7.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Behavioral: Anti-inflammatory energy-restricted diet Behavioral: Control energy-restricted diet	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

220 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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).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)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Mar 1, 2019

Anticipated Primary Completion Date :

Sep 1, 2021

Anticipated Study Completion Date :

Sep 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Anti-inflammatory 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	Behavioral: Anti-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.
Experimental: Control energy-resticted diet 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 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)

Arm

Intervention/Treatment

Experimental: Anti-inflammatory 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

Behavioral: Anti-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.

Experimental: Control energy-resticted diet

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

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)

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 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))
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 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Hospital Rijeka	Rijeka		Croatia	51000

Sponsors and Collaborators

Clinical Hospital Center Rijeka
University of Rijeka

Investigators

Principal Investigator: Sanja Klobučar Majanović, A. Prof., Clinical Hospital Centre Rijeka
Principal Investigator: Ines Mrakovčić Šutić, Prof., University of Rijeka, Faculty of Medicine
Principal Investigator: Gordana Kenđel Jovanović, Mag.nutr., Teaching Institute of Public Health of Primorsko-goranska County