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AzTrials

ObesityNCT03987776

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

A study testing Anti-inflammatory energy-restricted diet in people with Obesity, run by Clinical Hospital Center Rijeka at 1 site in Croatia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
Anti-inflammatory energy-restricted diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
1 siteCroatia
Study dates
1 Mar 2019to 7 Feb 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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
Show all 9Show fewer
  • active infection and/or surgical procedure in last 3 months
  • nutritive allergy or intolerance to any anti-inflammatory diet constituent
  • pregnancy

Trial locations and contacts

1 site in 1 country.

Croatia1 site

  • Clinical Hospital Rijeka

    Rijeka, 51000

Other trials in Croatia

About this study

Official title: The Effect of an Anti-Inflammatory Diet on Weight Loss, Body Composition, Cardiometabolic Risk Factors and Immune System Response in Younger Adults

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.

Read the 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®.

Conditions
Obesity
Being tested
Anti-inflammatory energy-restricted diet, Control energy-restricted diet
Keywords
anti-inflammatory diet, obesity, low-grade inflammation, cardiometabolic, immunity
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Anti-inflammatory energy-restricted dietBehavioural

    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 dietBehavioural

    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)

Study groups in NCT03987776
Study groupRoleWhat they receive
Anti-inflammatory dietExperimentalenergy-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
Receives: Behavioral: Anti-inflammatory energy-restricted diet
Control energy-resticted dietExperimentalisocaloric to anti-inflammatory diet, energy restricted diet (55-60% carbohydrates, 25% fat, 15-20% protein) used in a standard obesity management
Receives: Behavioral: Control energy-restricted diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The changes in the body mass index

    body mass index (kg/m2) calculated from measured body weight (kg) and height (m)

    Measured: baseline, follow up 6 months

  2. The changes in the waist circumference

    waist circumference (cm) measured with measuring tape

    Measured: baseline, follow up 6 months

  3. The changes of fat mass

    fat mass (kg) measured with bioelectric impedance analyzer

    Measured: baseline, follow up 6 months

  4. The changes of fat-free mass

    fat-free mass (kg) measured with bioelectric impedance analyzer

    Measured: baseline, follow up 6 months

  5. The changes of skeletal muscle mass

    skeletal muscle mass (kg) measured with bioelectric impedance analyzer

    Measured: baseline, follow up 6 months

  6. The changes of visceral adipose tissue

    visceral adipose tissue (l) measured with bioelectric impedance analyzer

    Measured: baseline, follow up 6 months

Secondary outcomes (13)

  1. The changes in fasting glucose concentration

    concentration of fasting glucose (mmol/l)

    Measured: baseline, follow up 6 months

  2. The changes in HbA1c concentration

    concentration of HbA1c (mmol/mol; %)

    Measured: baseline, follow up 6 months

  3. The changes in insulin concentration

    concentration of insulin (mU/l)

    Measured: baseline, follow up 6 months

  4. 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

    Measured: baseline, follow up 6 months

  5. The changes in serum lipid profile

    concentration of fasting triglycerides (mmol/l), HDL (mmol/l), LDL (mmol/l), total cholesterol (mmol/l)

    Measured: baseline, follow up 6 months

  6. 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))

    Measured: baseline, follow up 6 months

  7. 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)

    Measured: baseline, follow up 6 months

  8. The changes in serum hs-C-reactive protein concentration

    concentration of serum hs-C-reactive protein (mg/l)

    Measured: baseline, follow up 6 months

  9. 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+))

    Measured: baseline, follow up 6 months

  10. The changes in thyroid stimulating hormone (TSH) concentration

    concentration of TSH (mIU/l)

    Measured: baseline, follow up 6 months

  11. The changes in free tri-iodothyronine (fT3) concentration

    concentration of fT3 (pmol/l)

    Measured: baseline, follow up 6 months

  12. The changes in free thyroxine (fT4) concentration

    concentration of fT4 (pmol/l) and thyroid peroxidase antibodies concentration (IU/l)

    Measured: baseline, follow up 6 months

  13. The changes in thyroid peroxidase antibodies (TPOAbs) concentration

    concentration of TPOAbs (IU/l)

    Measured: baseline, follow up 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2019
  2. Study start1 Mar 2019
  3. Primary completion7 Feb 2023
  4. Study completion7 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
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).
Masking
None (open label)
Enrolment
220 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03987776
Sponsor's protocol ID
AIDIETOBESITY18-269/441
Status last verified
Feb 2023
First submitted
10 Jun 2019
Last updated
8 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: We planned to share the statistical analysis results of the study, after the study will be completed and published.

Publications

  • 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.

    PubMed 28617414

  • 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.

    PubMed 30389673

  • 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.

    PubMed 28722720

  • 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.

    PubMed 22795937

  • Satyaraj E. Emerging paradigms in immunonutrition. Top Companion Anim Med. 2011 Feb;26(1):25-32. doi: 10.1053/j.tcam.2011.01.004.

    PubMed 21435623

  • 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.

    PubMed 26258078

  • 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.

    PubMed 29807669

  • 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.

    PubMed 30904228

  • 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.

    PubMed 20234036

  • 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.

    PubMed 28350517

  • Agarwal AK. Spice up your life: adipose tissue and inflammation. J Lipids. 2014;2014:182575. doi: 10.1155/2014/182575. Epub 2014 Feb 20.

    PubMed 24701352

  • 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.

    PubMed 30651162

  • 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.

    PubMed 23768186

  • 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.

    PubMed 28342988

  • 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.

    PubMed 29678183

Questions about this trial

What is this clinical trial studying?

A study testing Anti-inflammatory energy-restricted diet in people with Obesity, run by Clinical Hospital Center Rijeka at 1 site in Croatia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The changes in the body mass index (time frame: baseline, follow up 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03987776, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.

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