Clinical trial NCT03987776: An Anti-inflammatory Diet Effect on Metabolic, Inflammatory and Immune Status of Obese Younger Adults
Official title: The Effect of an Anti-Inflammatory Diet on Weight Loss, Body Composition, Cardiometabolic Risk Factors and Immune System Response in Younger Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: anti-inflammatory diet
obesity
low-grade inflammation
cardiometabolic
immunity
Lead sponsor: Clinical Hospital Center Rijeka
Sponsor class: OTHER
Collaborators: name: University of Rijeka
First posted: 2019-06-17
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: BASIC_SCIENCE

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®.

Eligibility 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

Primary outcomes:
measure: The changes in the body mass index
timeFrame: baseline, follow up 6 months
measure: The changes in the waist circumference
timeFrame: baseline, follow up 6 months
measure: The changes of fat mass
timeFrame: baseline, follow up 6 months
measure: The changes of fat-free mass
timeFrame: baseline, follow up 6 months
measure: The changes of skeletal muscle mass
timeFrame: baseline, follow up 6 months
measure: The changes of visceral adipose tissue
timeFrame: baseline, follow up 6 months
Secondary outcomes:
measure: The changes in fasting glucose concentration
timeFrame: baseline, follow up 6 months
measure: The changes in HbA1c concentration
timeFrame: baseline, follow up 6 months
measure: The changes in insulin concentration
timeFrame: baseline, follow up 6 months
measure: The changes of HOMA-index
timeFrame: baseline, follow up 6 months
measure: The changes in serum lipid profile
timeFrame: baseline, follow up 6 months
measure: The changes in serum liver transaminases concentration
timeFrame: baseline, follow up 6 months
measure: The changes in serum IL-beta, IL-6 and TNF-alpha concentrations
timeFrame: baseline, follow up 6 months
measure: The changes in serum hs-C-reactive protein concentration
timeFrame: baseline, follow up 6 months
measure: The changes of blood lymphocytes T and lymphocite subgroups count
timeFrame: baseline, follow up 6 months
measure: The changes in thyroid stimulating hormone (TSH) concentration
timeFrame: baseline, follow up 6 months
measure: The changes in free tri-iodothyronine (fT3) concentration
timeFrame: baseline, follow up 6 months
measure: The changes in free thyroxine (fT4) concentration
timeFrame: baseline, follow up 6 months
measure: The changes in thyroid peroxidase antibodies (TPOAbs) concentration
timeFrame: baseline, follow up 6 months
Other outcomes:
Locations:
city: Rijeka
country: Croatia
facility: Clinical Hospital Rijeka
Study officials:
affiliation: Clinical Hospital Centre Rijeka
name: Sanja Klobučar Majanović, A. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Rijeka, Faculty of Medicine
name: Ines Mrakovčić Šutić, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Teaching Institute of Public Health of Primorsko-goranska County
name: Gordana Kenđel Jovanović, Mag.nutr.
role: PRINCIPAL_INVESTIGATOR
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