An Anti-inflammatory Diet Effect on Metabolic, Inflammatory and Immune Status of Obese Younger Adults
NCT ID: NCT03987776
Last Updated: 2023-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
220 participants
INTERVENTIONAL
2019-03-01
2023-02-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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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
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.
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
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)
Interventions
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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.
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)
Eligibility Criteria
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Inclusion Criteria
* body mass index ≥ 30 kg/m2
* with or without obesity related complications
Exclusion Criteria
* 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
18 Years
50 Years
ALL
Yes
Sponsors
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University of Rijeka
OTHER
Clinical Hospital Center Rijeka
OTHER
Responsible Party
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Sanja Klobučar Majanović
Assistant Professor
Principal Investigators
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Sanja Klobučar Majanović, A. Prof.
Role: PRINCIPAL_INVESTIGATOR
Clinical Hospital Centre Rijeka
Ines Mrakovčić Šutić, Prof.
Role: PRINCIPAL_INVESTIGATOR
University of Rijeka, Faculty of Medicine
Gordana Kenđel Jovanović, Mag.nutr.
Role: PRINCIPAL_INVESTIGATOR
Teaching Institute of Public Health of Primorsko-goranska County
Locations
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Clinical Hospital Rijeka
Rijeka, , Croatia
Countries
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References
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Gonzalez-Muniesa P, Martinez-Gonzalez MA, Hu FB, Despres JP, Matsuzawa Y, Loos RJF, Moreno LA, Bray GA, Martinez JA. Obesity. Nat Rev Dis Primers. 2017 Jun 15;3:17034. doi: 10.1038/nrdp.2017.34.
Salas-Salvado J, Diaz-Lopez A, Ruiz-Canela M, Basora J, Fito M, Corella D, Serra-Majem L, Warnberg J, Romaguera D, Estruch R, Vidal J, Martinez JA, Aros F, Vazquez C, Ros E, Vioque J, Lopez-Miranda J, Bueno-Cavanillas A, Tur JA, Tinahones FJ, Martin V, Lapetra J, Pinto X, Daimiel L, Delgado-Rodriguez M, Matia P, Gomez-Gracia E, Diez-Espino J, Babio N, Castaner O, Sorli JV, Fiol M, Zulet MA, Bullo M, Goday A, Martinez-Gonzalez MA; PREDIMED-Plus investigators. Effect of a Lifestyle Intervention Program With Energy-Restricted Mediterranean Diet and Exercise on Weight Loss and Cardiovascular Risk Factors: One-Year Results of the PREDIMED-Plus Trial. Diabetes Care. 2019 May;42(5):777-788. doi: 10.2337/dc18-0836. Epub 2018 Nov 2.
Netea MG, Balkwill F, Chonchol M, Cominelli F, Donath MY, Giamarellos-Bourboulis EJ, Golenbock D, Gresnigt MS, Heneka MT, Hoffman HM, Hotchkiss R, Joosten LAB, Kastner DL, Korte M, Latz E, Libby P, Mandrup-Poulsen T, Mantovani A, Mills KHG, Nowak KL, O'Neill LA, Pickkers P, van der Poll T, Ridker PM, Schalkwijk J, Schwartz DA, Siegmund B, Steer CJ, Tilg H, van der Meer JWM, van de Veerdonk FL, Dinarello CA. A guiding map for inflammation. Nat Immunol. 2017 Jul 19;18(8):826-831. doi: 10.1038/ni.3790.
Schipper HS, Prakken B, Kalkhoven E, Boes M. Adipose tissue-resident immune cells: key players in immunometabolism. Trends Endocrinol Metab. 2012 Aug;23(8):407-15. doi: 10.1016/j.tem.2012.05.011. Epub 2012 Jul 12.
Satyaraj E. Emerging paradigms in immunonutrition. Top Companion Anim Med. 2011 Feb;26(1):25-32. doi: 10.1053/j.tcam.2011.01.004.
Salama AA, Amine EK, Salem HA, Abd El Fattah NK. Anti-Inflammatory Dietary Combo in Overweight and Obese Women with Polycystic Ovary Syndrome. N Am J Med Sci. 2015 Jul;7(7):310-6. doi: 10.4103/1947-2714.161246.
Mayr HL, Itsiopoulos C, Tierney AC, Ruiz-Canela M, Hebert JR, Shivappa N, Thomas CJ. Improvement in dietary inflammatory index score after 6-month dietary intervention is associated with reduction in interleukin-6 in patients with coronary heart disease: The AUSMED heart trial. Nutr Res. 2018 Jul;55:108-121. doi: 10.1016/j.nutres.2018.04.007. Epub 2018 Apr 25.
Turner-McGrievy GM, Wirth MD, Shivappa N, Dunn CG, Crimarco A, Hurley TG, West DS, Hussey JR, Hebert JR. Impact of a 12-month Inflammation Management Intervention on the Dietary Inflammatory Index, inflammation, and lipids. Clin Nutr ESPEN. 2019 Apr;30:42-51. doi: 10.1016/j.clnesp.2019.02.008. Epub 2019 Mar 1.
Sears B. Anti-inflammatory diets for obesity and diabetes. J Am Coll Nutr. 2009 Aug;28 Suppl:482S-491S. doi: 10.1080/07315724.2009.10718115.
Ricker MA, Haas WC. Anti-Inflammatory Diet in Clinical Practice: A Review. Nutr Clin Pract. 2017 Jun;32(3):318-325. doi: 10.1177/0884533617700353. Epub 2017 Mar 28.
Agarwal AK. Spice up your life: adipose tissue and inflammation. J Lipids. 2014;2014:182575. doi: 10.1155/2014/182575. Epub 2014 Feb 20.
Jiang TA. Health Benefits of Culinary Herbs and Spices. J AOAC Int. 2019 Mar 1;102(2):395-411. doi: 10.5740/jaoacint.18-0418. Epub 2019 Jan 16.
Rubio L, Motilva MJ, Romero MP. Recent advances in biologically active compounds in herbs and spices: a review of the most effective antioxidant and anti-inflammatory active principles. Crit Rev Food Sci Nutr. 2013;53(9):943-53. doi: 10.1080/10408398.2011.574802.
Ramirez AG, Parma DL, Munoz E, Mendoza KD, Harb C, Holden AEC, Wargovich M. An anti-inflammatory dietary intervention to reduce breast cancer recurrence risk: Study design and baseline data. Contemp Clin Trials. 2017 Jun;57:1-7. doi: 10.1016/j.cct.2017.03.009. Epub 2017 Mar 22.
Winkvist A, Barebring L, Gjertsson I, Ellegard L, Lindqvist HM. A randomized controlled cross-over trial investigating the effect of anti-inflammatory diet on disease activity and quality of life in rheumatoid arthritis: the Anti-inflammatory Diet In Rheumatoid Arthritis (ADIRA) study protocol. Nutr J. 2018 Apr 20;17(1):44. doi: 10.1186/s12937-018-0354-x.
McMorrow AM, Connaughton RM, Magalhaes TR, McGillicuddy FC, Hughes MF, Cheishvili D, Morine MJ, Ennis S, Healy ML, Roche EF, Tremblay RE, Szyf M, Lithander FE, Roche HM. Personalized Cardio-Metabolic Responses to an Anti-Inflammatory Nutrition Intervention in Obese Adolescents: A Randomized Controlled Crossover Trial. Mol Nutr Food Res. 2018 May;62(10):e1701008. doi: 10.1002/mnfr.201701008.
Yannakoulia M, Poulimeneas D, Mamalaki E, Anastasiou CA. Dietary modifications for weight loss and weight loss maintenance. Metabolism. 2019 Mar;92:153-162. doi: 10.1016/j.metabol.2019.01.001. Epub 2019 Jan 6.
Bianchi VE. Weight loss is a critical factor to reduce inflammation. Clin Nutr ESPEN. 2018 Dec;28:21-35. doi: 10.1016/j.clnesp.2018.08.007. Epub 2018 Sep 3.
Medina-Remon A, Casas R, Tressserra-Rimbau A, Ros E, Martinez-Gonzalez MA, Fito M, Corella D, Salas-Salvado J, Lamuela-Raventos RM, Estruch R; PREDIMED Study Investigators. Polyphenol intake from a Mediterranean diet decreases inflammatory biomarkers related to atherosclerosis: a substudy of the PREDIMED trial. Br J Clin Pharmacol. 2017 Jan;83(1):114-128. doi: 10.1111/bcp.12986. Epub 2016 May 19.
Shivappa N, Steck SE, Hurley TG, Hussey JR, Hebert JR. Designing and developing a literature-derived, population-based dietary inflammatory index. Public Health Nutr. 2014 Aug;17(8):1689-96. doi: 10.1017/S1368980013002115. Epub 2013 Aug 14.
Shivappa N, Steck SE, Hurley TG, Hussey JR, Ma Y, Ockene IS, Tabung F, Hebert JR. A population-based dietary inflammatory index predicts levels of C-reactive protein in the Seasonal Variation of Blood Cholesterol Study (SEASONS). Public Health Nutr. 2014 Aug;17(8):1825-33. doi: 10.1017/S1368980013002565. Epub 2013 Oct 10.
Namazi N, Larijani B, Azadbakht L. Dietary Inflammatory Index and its Association with the Risk of Cardiovascular Diseases, Metabolic Syndrome, and Mortality: A Systematic Review and Meta-Analysis. Horm Metab Res. 2018 May;50(5):345-358. doi: 10.1055/a-0596-8204. Epub 2018 May 3.
Hebert JR, Shivappa N, Wirth MD, Hussey JR, Hurley TG. Perspective: The Dietary Inflammatory Index (DII)-Lessons Learned, Improvements Made, and Future Directions. Adv Nutr. 2019 Mar 1;10(2):185-195. doi: 10.1093/advances/nmy071.
Kendel Jovanovic G, Mrakovcic-Sutic I, Pavicic Zezelj S, Susa B, Rahelic D, Klobucar Majanovic S. The Efficacy of an Energy-Restricted Anti-Inflammatory Diet for the Management of Obesity in Younger Adults. Nutrients. 2020 Nov 22;12(11):3583. doi: 10.3390/nu12113583.
Kendel Jovanovic G, Pavicic Zezelj S, Klobucar Majanovic S, Mrakovcic-Sutic I, Sutic I. Metabolic syndrome and its association with the Dietary Inflammatory Index (DII)(R) in a Croatian working population. J Hum Nutr Diet. 2020 Feb;33(1):128-137. doi: 10.1111/jhn.12695. Epub 2019 Oct 11.
Other Identifiers
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AIDIETOBESITY18-269/441
Identifier Type: -
Identifier Source: org_study_id
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