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| Name | Class |
|---|---|
| University of Rijeka | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anti-inflammatory diet | Experimental | 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 |
|
| Control energy-resticted diet | Experimental | isocaloric to anti-inflammatory diet, energy restricted diet (55-60% carbohydrates, 25% fat, 15-20% protein) used in a standard obesity management |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-inflammatory energy-restricted diet | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The changes in the body mass index | 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 | waist circumference (cm) measured with measuring tape | baseline, follow up 6 months |
| The changes of fat mass | fat mass (kg) measured with bioelectric impedance analyzer | baseline, follow up 6 months |
| The changes of fat-free mass | fat-free mass (kg) measured with bioelectric impedance analyzer | baseline, follow up 6 months |
| The changes of skeletal muscle mass | skeletal muscle mass (kg) measured with bioelectric impedance analyzer | baseline, follow up 6 months |
| The changes of visceral adipose tissue | visceral adipose tissue (l) measured with bioelectric impedance analyzer | baseline, follow up 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| The changes in fasting glucose concentration | concentration of fasting glucose (mmol/l) | baseline, follow up 6 months |
| The changes in HbA1c concentration | concentration of HbA1c (mmol/mol; %) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sanja Klobučar Majanović, A. Prof. | Clinical Hospital Centre Rijeka | Principal Investigator |
| Ines Mrakovčić Šutić, Prof. | University of Rijeka | Principal Investigator |
| Gordana Kenđel Jovanović, Mag.nutr. | Teaching Institute of Public Health of Primorsko-goranska County | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Hospital Rijeka | Rijeka | 51000 | Croatia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28617414 | Background | 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. | |
| 30389673 | Background | 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. |
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We planned to share the statistical analysis results of the study, after the study will be completed and published.
The data will be available one year after ending of the study for an year.
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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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).
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|
| Control energy-restricted diet | Behavioral | 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) |
|
| baseline, follow up 6 months |
| The changes in insulin concentration | concentration of insulin (mU/l) | baseline, follow up 6 months |
| The changes of HOMA-index | 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 | 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 | 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 | 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 | concentration of serum hs-C-reactive protein (mg/l) | baseline, follow up 6 months |
| The changes of blood lymphocytes T and lymphocite subgroups count | 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 | concentration of TSH (mIU/l) | baseline, follow up 6 months |
| The changes in free tri-iodothyronine (fT3) concentration | concentration of fT3 (pmol/l) | baseline, follow up 6 months |
| The changes in free thyroxine (fT4) concentration | 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 | concentration of TPOAbs (IU/l) | baseline, follow up 6 months |
| 28722720 | Background | 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. |
| 22795937 | Background | 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. |
| 21435623 | Background | Satyaraj E. Emerging paradigms in immunonutrition. Top Companion Anim Med. 2011 Feb;26(1):25-32. doi: 10.1053/j.tcam.2011.01.004. |
| 26258078 | Background | 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. |
| 29807669 | Background | 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. |
| 30904228 | Background | 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. |
| 20234036 | Background | 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. |
| 28350517 | Background | 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. |
| 24701352 | Background | Agarwal AK. Spice up your life: adipose tissue and inflammation. J Lipids. 2014;2014:182575. doi: 10.1155/2014/182575. Epub 2014 Feb 20. |
| 30651162 | Background | 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. |
| 23768186 | Background | 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. |
| 28342988 | Background | 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. |
| 29678183 | Background | 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. |
| 29665620 | Background | 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. |
| 30625301 | Background | 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. |
| 30390883 | Background | 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. |
| 27100393 | Background | 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. |
| 23941862 | Background | 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. |
| 24107546 | Background | 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. |
| 29723899 | Background | 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. |
| 30615051 | Background | 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. |
| 33266499 | Background | 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. |
| 31602707 | Background | 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. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |