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

NCT03987776 | Completed

• 1 other identifier: AIDIETOBESITY18-269/441
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

anti-inflammatory diet; obesity; low-grade inflammation; cardiometabolic; immunity

Outcome Measures

Primary Outcomes (6)

• 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

Secondary Outcomes (13)

• The changes in fasting glucose concentration

  baseline, follow up 6 months

• The changes in HbA1c concentration

  baseline, follow up 6 months

• The changes in insulin concentration

  baseline, follow up 6 months

• The changes of HOMA-index

  baseline, follow up 6 months

• The changes in serum lipid profile

  baseline, follow up 6 months

Study Arms (2)

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

Behavioral: Anti-inflammatory energy-restricted diet

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

Behavioral: Control energy-restricted diet

Interventions

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.

Anti-inflammatory diet

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)

Control energy-resticted diet

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• adults age of 18 to 50 years
• body mass index ≥ 30 kg/m2
• with or without obesity related complications

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinical Hospital Center Rijeka: lead
• University of Rijeka: collaborator

Study Sites (1)

Clinical Hospital Rijeka

Rijeka, 51000, Croatia

Location

Related Publications (25)

• 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.

  PMID: 28617414 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.

  PMID: 30389673 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.

  PMID: 28722720 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.

  PMID: 22795937 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.

  PMID: 21435623 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.

  PMID: 26258078 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.

  PMID: 29807669 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.

  PMID: 30904228 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.

  PMID: 20234036 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.

  PMID: 28350517 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.

  PMID: 24701352 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.

  PMID: 30651162 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.

  PMID: 23768186 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.

  PMID: 28342988 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.

  PMID: 29678183 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.

  PMID: 29665620 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.

  PMID: 30625301 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.

  PMID: 30390883 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.

  PMID: 27100393 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.

  PMID: 23941862 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.

  PMID: 24107546 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.

  PMID: 29723899 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.

  PMID: 30615051 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.

  PMID: 33266499 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.

  PMID: 31602707 BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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).

Study Record Dates

• First Submitted: June 10, 2019
• First Posted: June 17, 2019
• Study Start: March 1, 2019
• Primary Completion: February 7, 2023
• Study Completion: February 7, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will be available one year after ending of the study for an year.

Locations

CR (1)