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,
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* 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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