Investigating the effect Functional Edible Powder Enriched with Probiotics, Curcumin, or Their Combination on Some Inflammatory Markers, Fasting Blood Glucose, and Blood Pressure in Overweight or Obese Individuals with Metabolic Syndrome

Authors
Category Primary study
Registry of TrialsIranian Registry of Clinical Trials
Year 2022
INTERVENTION: Intervention 1: Intervention group 1: Dissolve and receive curcumin‐enriched edible functional powder containing 1000 mg of curcumin (Karen Pharma and Food Supplement Co.) in water daily for 8 weeks. They also follow a low‐calorie diet with a reduction of 500 kcal during the study. Intervention 2: Intervention group 2: Dissolve and receive probiotic‐enriched edible functional powder containing 10^9 CFU of Lactobacillus rhamnosus and Lactobacillus acidophilus (Parsilact Co.) in water daily for 8 weeks. They also follow a low‐calorie diet with a reduction of 500 kcal during the study. Intervention 3: Intervention group 3: Dissolve and receive curcumin‐probiotic‐enriched edible functional powder containing 1000 mg of curcumin (Karen Pharma and Food Supplement Co.) and 10^9 CFU of Lactobacillus rhamnosus and Lactobacillus acidophilus (Parsilact Co.) in water daily for 8 weeks. They also follow a low‐calorie diet with a reduction of 500 kcal during the study. Intervention 4: Control group: Dissolve and receive placebo powder in water daily for 8 weeks. They also follow a low‐calorie diet with a reduction of 500 kcal during the study. CONDITION: Metabolic syndrome. ; Metabolic syndrome E88.81 PRIMARY OUTCOME: Tumor necrosis factor alpha (TNF‐a) blood level. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Enzyme‐linked immuno_sorbent assay (ELISA). High‐sensitivity C‐reactive Protein (hs‐CRP) blood level. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Enzyme‐linked immuno_sorbent assay (ELISA). Interleukin 6 (IL‐6) blood level. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Enzyme‐linked immuno_sorbent assay (ELISA). SECONDARY OUTCOME: Diastolic blood pressure. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Sphygmomanometer. Fasting blood glucose. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Standard enzymatic method. Systolic blood pressure. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Sphygmomanometer. INCLUSION CRITERIA: Aged 30 ‐ 65 years Overweight (BMI between 25 to 29.9) or obese (BMI over 30) individuals with metabolic syndrome based on ATP III criteria Not suffering from metabolic, endocrine, or cardiovascular disease (except diabetes, dyslipidemia, and hypertension) at baseline Not suffering from kidney, liver, or systemic diseases at the beginning of the study Not infected with Covid‐19 or any other infections for 3 months before the study No history of hospitalization for 3 months prior to the study Has not used antibiotics for 3 months before beginning the study Has not taken curcumin and probiotic supplements, any drugs or supplements for 3 months before the study
Epistemonikos ID: facd4cd9c6c0c8ce0ce156f546d82f413f9a7b42
First added on: Apr 08, 2022