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Completed

NCT Number: NCT03987776

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

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Key information

Conditions

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

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Hospital Rijeka

Rijeka, 51000, Croatia

About this study

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®.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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)

Primary outcomes

  1. The changes in the body mass index

    Time frame: baseline, follow up 6 months

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

  2. The changes in the waist circumference

    Time frame: baseline, follow up 6 months

    waist circumference (cm) measured with measuring tape

  3. The changes of fat mass

    Time frame: baseline, follow up 6 months

    fat mass (kg) measured with bioelectric impedance analyzer

  4. The changes of fat-free mass

    Time frame: baseline, follow up 6 months

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

  5. The changes of skeletal muscle mass

    Time frame: baseline, follow up 6 months

    skeletal muscle mass (kg) measured with bioelectric impedance analyzer

  6. The changes of visceral adipose tissue

    Time frame: baseline, follow up 6 months

    visceral adipose tissue (l) measured with bioelectric impedance analyzer

Secondary outcomes

  1. The changes in fasting glucose concentration

    Time frame: baseline, follow up 6 months

    concentration of fasting glucose (mmol/l)

  2. The changes in HbA1c concentration

    Time frame: baseline, follow up 6 months

    concentration of HbA1c (mmol/mol; %)

  3. The changes in insulin concentration

    Time frame: baseline, follow up 6 months

    concentration of insulin (mU/l)

  4. The changes of HOMA-index

    Time frame: baseline, follow up 6 months

    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

  5. The changes in serum lipid profile

    Time frame: baseline, follow up 6 months

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

  6. The changes in serum liver transaminases concentration

    Time frame: baseline, follow up 6 months

    concentration of serum fasting liver transaminases (AST (U/l), ALT (U/l), GGT (U/l), ALP (U/l))

  7. The changes in serum IL-beta, IL-6 and TNF-alpha concentrations

    Time frame: baseline, follow up 6 months

    concentration of serum IL-1 beta (pg/ml), IL-6 (pg/ml), TNF-alpha (pg/ml)

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

    Time frame: baseline, follow up 6 months

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

  9. The changes of blood lymphocytes T and lymphocite subgroups count

    Time frame: baseline, follow up 6 months

    count of blood lymphocytes T, lymphocyte subgroups (TCD3, TCD4, TCD8, BCD19, NKCs, Tregs (CD4+CD25+Foxp3+))

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

    Time frame: baseline, follow up 6 months

    concentration of TSH (mIU/l)

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

    Time frame: baseline, follow up 6 months

    concentration of fT3 (pmol/l)

  12. The changes in free thyroxine (fT4) concentration

    Time frame: baseline, follow up 6 months

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

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

    Time frame: baseline, follow up 6 months

    concentration of TPOAbs (IU/l)

Sponsors and collaborators

Lead sponsor

Clinical Hospital Center Rijeka

Other

Collaborators

  • University of Rijeka

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jun 17, 2019
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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