Obesity Clinical Trial
Official title:
The Effect of an Anti-Inflammatory Diet on Weight Loss, Body Composition, Cardiometabolic Risk Factors and Immune System Response in Younger Adults
Verified date | February 2023 |
Source | Clinical Hospital Center Rijeka |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 220 |
Est. completion date | February 7, 2023 |
Est. primary completion date | February 7, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Croatia | Clinical Hospital Rijeka | Rijeka |
Lead Sponsor | Collaborator |
---|---|
Clinical Hospital Center Rijeka | University of Rijeka |
Croatia,
Agarwal AK. Spice up your life: adipose tissue and inflammation. J Lipids. 2014;2014:182575. doi: 10.1155/2014/182575. Epub 2014 Feb 20. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. Erratum In: Nat Immunol. 2021 Feb;22(2):254. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Satyaraj E. Emerging paradigms in immunonutrition. Top Companion Anim Med. 2011 Feb;26(1):25-32. doi: 10.1053/j.tcam.2011.01.004. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
* Note: There are 25 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | The changes in the waist circumference | waist circumference (cm) measured with measuring tape | baseline, follow up 6 months | |
Primary | The changes of fat mass | fat mass (kg) measured with bioelectric impedance analyzer | baseline, follow up 6 months | |
Primary | The changes of fat-free mass | fat-free mass (kg) measured with bioelectric impedance analyzer | baseline, follow up 6 months | |
Primary | The changes of skeletal muscle mass | skeletal muscle mass (kg) measured with bioelectric impedance analyzer | baseline, follow up 6 months | |
Primary | The changes of visceral adipose tissue | visceral adipose tissue (l) measured with bioelectric impedance analyzer | baseline, follow up 6 months | |
Secondary | The changes in fasting glucose concentration | concentration of fasting glucose (mmol/l) | baseline, follow up 6 months | |
Secondary | The changes in HbA1c concentration | concentration of HbA1c (mmol/mol; %) | baseline, follow up 6 months | |
Secondary | The changes in insulin concentration | concentration of insulin (mU/l) | baseline, follow up 6 months | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | The changes in serum hs-C-reactive protein concentration | concentration of serum hs-C-reactive protein (mg/l) | baseline, follow up 6 months | |
Secondary | 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 | |
Secondary | The changes in thyroid stimulating hormone (TSH) concentration | concentration of TSH (mIU/l) | baseline, follow up 6 months | |
Secondary | The changes in free tri-iodothyronine (fT3) concentration | concentration of fT3 (pmol/l) | baseline, follow up 6 months | |
Secondary | The changes in free thyroxine (fT4) concentration | concentration of fT4 (pmol/l) and thyroid peroxidase antibodies concentration (IU/l) | baseline, follow up 6 months | |
Secondary | The changes in thyroid peroxidase antibodies (TPOAbs) concentration | concentration of TPOAbs (IU/l) | baseline, follow up 6 months |
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