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

February 7, 2023 updated by: Sanja Klobučar Majanović, Clinical Hospital Center Rijeka

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Rijeka, Croatia, 51000
        • Clinical Hospital Rijeka

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The changes in the body mass index
Time Frame: baseline, follow up 6 months
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
Time Frame: baseline, follow up 6 months
waist circumference (cm) measured with measuring tape
baseline, follow up 6 months
The changes of fat mass
Time Frame: baseline, follow up 6 months
fat mass (kg) measured with bioelectric impedance analyzer
baseline, follow up 6 months
The changes of fat-free mass
Time Frame: baseline, follow up 6 months
fat-free mass (kg) measured with bioelectric impedance analyzer
baseline, follow up 6 months
The changes of skeletal muscle mass
Time Frame: baseline, follow up 6 months
skeletal muscle mass (kg) measured with bioelectric impedance analyzer
baseline, follow up 6 months
The changes of visceral adipose tissue
Time Frame: baseline, follow up 6 months
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
Time Frame: baseline, follow up 6 months
concentration of fasting glucose (mmol/l)
baseline, follow up 6 months
The changes in HbA1c concentration
Time Frame: baseline, follow up 6 months
concentration of HbA1c (mmol/mol; %)
baseline, follow up 6 months
The changes in insulin concentration
Time Frame: baseline, follow up 6 months
concentration of insulin (mU/l)
baseline, follow up 6 months
The changes of HOMA-index
Time Frame: 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
baseline, follow up 6 months
The changes in serum lipid profile
Time Frame: baseline, follow up 6 months
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
Time Frame: baseline, follow up 6 months
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
Time Frame: baseline, follow up 6 months
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
Time Frame: baseline, follow up 6 months
concentration of serum hs-C-reactive protein (mg/l)
baseline, follow up 6 months
The changes of blood lymphocytes T and lymphocite subgroups count
Time Frame: baseline, follow up 6 months
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
Time Frame: baseline, follow up 6 months
concentration of TSH (mIU/l)
baseline, follow up 6 months
The changes in free tri-iodothyronine (fT3) concentration
Time Frame: baseline, follow up 6 months
concentration of fT3 (pmol/l)
baseline, follow up 6 months
The changes in free thyroxine (fT4) concentration
Time Frame: baseline, follow up 6 months
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
Time Frame: baseline, follow up 6 months
concentration of TPOAbs (IU/l)
baseline, follow up 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinical Hospital Center Rijeka

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2019

Primary Completion (ACTUAL)

February 7, 2023

Study Completion (ACTUAL)

February 7, 2023

Study Registration Dates

First Submitted

June 10, 2019

First Submitted That Met QC Criteria

June 14, 2019

First Posted (ACTUAL)

June 17, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIDIETOBESITY18-269/441

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We planned to share the statistical analysis results of the study, after the study will be completed and published.

IPD Sharing Time Frame

The data will be available one year after ending of the study for an year.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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