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

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ClinicalTrials.gov Identifier: NCT03987776
Recruitment Status : Recruiting
First Posted : June 17, 2019
Last Update Posted : June 17, 2019
Sponsor:
Collaborator:
University of Rijeka
Information provided by (Responsible Party):
Sanja Klobučar Majanović, 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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Anti-inflammatory energy-restricted diet Behavioral: Control energy-restricted diet Not Applicable

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®.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 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).
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 : March 1, 2019
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : September 1, 2019

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)




Primary Outcome Measures :
  1. 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)

  2. The changes in the waist circumference [ Time Frame: baseline, follow up 6 months ]
    waist circumference (cm) measured with measuring tape

  3. The changes of fat mass [ Time Frame: baseline, follow up 6 months ]
    fat mass (kg) measured with bioelectric impedance analyzer

  4. The changes of fat-free mass [ Time Frame: baseline, follow up 6 months ]
    fat-free mass (kg) measured with bioelectric impedance analyzer

  5. The changes of skeletal muscle mass [ Time Frame: baseline, follow up 6 months ]
    skeletal muscle mass (kg) measured with bioelectric impedance analyzer

  6. The changes of visceral adipose tissue [ Time Frame: baseline, follow up 6 months ]
    visceral adipose tissue (l) measured with bioelectric impedance analyzer


Secondary Outcome Measures :
  1. The changes in fasting glucose concentration [ Time Frame: baseline, follow up 6 months ]
    concentration of fasting glucose (mmol/l)

  2. The changes in HbA1c concentration [ Time Frame: baseline, follow up 6 months ]
    concentration of HbA1c (mmol/mol; %)

  3. The changes in insulin concentration [ Time Frame: baseline, follow up 6 months ]
    concentration of insulin (mU/l)

  4. 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

  5. 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)

  6. 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))

  7. 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)

  8. 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)

  9. 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+))

  10. The changes in thyroid stimulating hormone (TSH) concentration [ Time Frame: baseline, follow up 6 months ]
    concentration of TSH (mIU/l)

  11. The changes in free tri-iodothyronine (fT3) concentration [ Time Frame: baseline, follow up 6 months ]
    concentration of fT3 (pmol/l)

  12. 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)

  13. The changes in thyroid peroxidase antibodies (TPOAbs) concentration [ Time Frame: baseline, follow up 6 months ]
    concentration of TPOAbs (IU/l)



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03987776


Contacts
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Contact: Sanja Klobučar Majanović, A. Prof. +38598695104 sanja.klobucarm@gmail.com
Contact: Gordana Kenđel Jovanović, Mag. nutr. +385989092355 gordana.kendel-jovanovic@zzjzpgz.hr

Locations
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Croatia
Clinical Hospital Rijeka Recruiting
Rijeka, Croatia, 51000
Contact: Sanja Klobučar Majanović, Assist. Prof.    +38598695104    sanja.klobucarm@gmail.com   
Contact: Gordana Kenđel Jovanović, mag.nutr    +385989092355    gordana.kendel-jovanovic@zzjzpgz.hr   
Principal Investigator: Ines Mrakovčić Šutić, Prof.         
Sponsors and Collaborators
Clinical Hospital Center Rijeka
University of Rijeka
Investigators
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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:

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Responsible Party: Sanja Klobučar Majanović, Assistant Professor, Clinical Hospital Center Rijeka
ClinicalTrials.gov Identifier: NCT03987776     History of Changes
Other Study ID Numbers: AIDIETOBESITY18-269/441
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We planned to share the statistical analysis results of the study, after the study will be completed and published.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: The data will be available one year after ending of the study for an year.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sanja Klobučar Majanović, Clinical Hospital Center Rijeka:
anti-inflammatory diet
obesity
low-grade inflammation
cardiometabolic
immunity

Additional relevant MeSH terms:
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Anti-Inflammatory Agents