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IRCT2015042917254N3 IRCT 2015-05-09 Vice chancellor for research,Tehran University of Medical Sciences The effect of cardamom supplementation on blood oxidative stress status and inflammatory factors in prediabetic women The effect of cardamom supplementation on blood oxidative stress status and inflammatory factors in overweight and obese prediabetic women 2013-03-20 anticipated 80 Complete https://irct.ir/trial/15917 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention. 2-3 Pre diabetes. Intervention 1: group receiving green cardamom :capsules containing 1g cardamom, three a day for 2 month. Intervention 2: placebo group receiving rusk powder: capsules containing 1g of rusk powder, three a day for 2 month.
public Fatemeh Yaghooblou
No 44, Hojjat doost St, Naderi St, Keshavarz Blv, School of Nutritional Sciences and Dietetic,Tehran, Iran.
Tehran Iran (Islamic Republic of) +98 26 3451 4381 yaghooblou.fatemeh@yahoo.com Tehran university of Medical Sciences scientific Dr. Sotoude
No 44, Hojjat doost St, Naderi St, Keshavarz Blv, School of Nutritional Sciences and Dietetic,Tehran, Iran.
Tehran Iran (Islamic Republic of) +98 21 8895 5118 gsotodeh@tums.ac.ir Tehran university of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Inclusion criteria: Prediabetic women with one of the following criteria: FBS; 100-125 mg/dl, HbA1C: 5.7-6.4, 2hpp blood glucose: 140-199 mg/dl; Age: 30-70 years; BMI: 25-39.9 kg/m2; Having at least one of the following criteria: TG>150 mg/dl, Chol>200 mg/dl, LDL>100 mg/dl, HDL<50 mg/dl; Willingness to participate in the study. Not included in the study: BMI<25 kg/m2 or BMI≥40 kg/m2; Following a specific diet for last three months; Professional athlete; Sensitivity to Cardamom (allergy); Pregnancy and lactation; Nutritional supplement and multi vitamin-mineral consumption at least 2 times a week in the last month; Medical history of gastrointestinal ulcers, kidney or gall stones; Medical history of coronary heart disease, cancer and MS; Blood pressure>130/80 mmHg; LDL>160 mg/dl; TG>300 mg/dl; Smoking. Exclusion criteria: Multi vitamin and anti oxidant supplements consumption during the intervention; Changes in diet or physical activity; Not intaking of more than 10% of supplements; Morbidity to diabetes during the intervention. 30 years 70 years Female R73.0 Impaired glucose tolerance Prediabetes Other Placebo group receiving green cardamom :capsules containing 1g cardamom, three a day for 2 month placebo group receiving rusk powder: capsules containing 1g of rusk powder, three a day for 2 month GR activity. Timepoint: before and after the intervention. Method of measurement: Enzymatic Measurement of fasting GR activity by using kits. SOD activity. Timepoint: before and after the intervention. Method of measurement: Enzymatic Measurement of fasting SOD activity by using kits. Serum Total Antioxidant Capacity. Timepoint: before and after the intervention. Method of measurement: Enzymatic Measurement of Serum Total Antioxidant Capacity by using kits. MDA Concentration. Timepoint: before and after the intervention. Method of measurement: Enzymatic Measurement of fasting MDA Concentration by using kits. Protein Carbonyl Concentration. Timepoint: before and after the intervention. Method of measurement: Enzymatic Measurement of fasting Protein Carbonyl Concentration by using kits. IL-6 Concentration. Timepoint: before and after the intervention. Method of measurement: Enzymatic Measurement of fasting IL-6 Concentration by using kits. Hs-CRP Concentration. Timepoint: before and after the intervention. Method of measurement: Enzymatic Measurement of fasting hs-CRP Concentration by using kits. TNF-α Concentration. Timepoint: before and after the intervention. Method of measurement: Enzymatic Measurement of fasting TNF-α Concentration by using kits. Waist circumference. Timepoint: before and after the intervention. Method of measurement: measurement with a meter. BMI. Timepoint: before and after the intervention. Method of measurement: Measured with formula. Weight. Timepoint: before and after the intervention. Method of measurement: Measured with a digital scale. Vice chancellor for research,Tehran University of Medical Sciences Approved 2014-07-26 Ethics Committee of Tehran University of Medical Sciences 6th floor, the main organization of Tehran University of Medical sciences, at the corner of Qods Stt, Keshvarz Blv Tehran Iran (Islamic Republic of)