The effect of nanomicelle curcumin in children with Crohn's disease

Authors
Category Primary study
Registry of TrialsIranian Registry of Clinical Trials
Year 2023
INTERVENTION: Intervention 1: Intervention group: weight gain diet (500 kcal more than daily requirement) and two nanomicelle curcumin supplements (containing 40 mg of nanomicelle curcumin manufactured by Nanosina) are prescribed to the participants for 12 weeks. Intervention 2: Control group: receiving weight gain diet (500 kcal more than daily requirement) and placebo (the same amount and form of nanomicelle curcumin supplements manufactured by Nanosina Company), prescribed twice a day for 12 weeks. CONDITION: Children's Crohn's disease. ; Crohn's disease [regional enteritis] PRIMARY OUTCOME: Body mass index. Timepoint: At the beginning of the study (before the start of the intervention) and12 weeks after the start of the supplement. Method of measurement: Formula (weight/height squared). Body weight. Timepoint: At the beginning of the study (before the start of the intervention) and 4, 8 and 12 weeks after the start of the supplement consumption. Method of measurement: Scales. Height. Timepoint: At the beginning of the study (before the start of the intervention) and 4, 8 and 12 weeks after the start of the supplement consumption. Method of measurement: tape measure. Serum albumin. Timepoint: At the beginning of the study (before the start of the intervention) and12 weeks after the start of the supplement consumption. Method of measurement: Biochemical analysis of blood sample. SECONDARY OUTCOME: Body composition (fat mass, fat‐free mass, lean body mass, skeletal muscle index, total body water content, basal metabolic rate). Timepoint: At the beginning of the study (before the start of the intervention) and 4, 8 and 12 weeks after the start of the supplement. Method of measurement: Bioelectric Impedance Analysis (BIA) device. Dietary intake. Timepoint: At the beginning of the study (before the start of the intervention) and12 weeks after the start of the supplement. Method of measurement: 3‐day 24‐hour recall. Inflammation status (C‐reactive protein). Timepoint: At the beginning of the study (before the start of the intervention) and12 weeks after the start of the supplement. Method of measurement: Biochemical analysis of blood sample. Oxidative stress status(Interleukin 10). Timepoint: At the beginning of the study (before the start of the intervention) and12 weeks after the start of the supplement. Method of measurement: ELISA. Quality of Life. Timepoint: At the beginning of the study (before the start of the intervention) and 12 weeks after the start of the supplement. Method of measurement: Quality of life questionnaire for Crohn's patients. INCLUSION CRITERIA: Children 8 to 18 years old with Crohn's disease Mild to moderate disease severity based on Crohn's Disease Activity Inde X(CDAI) Interested in participating in the project and willing to follow the study protocol Informed consent has been obtained from the patients
Epistemonikos ID: f6bf325dec453ab61105300a4c184614cefd855b
First added on: Dec 30, 2023