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IRCT20181120041710N2 IRCT 2020-02-10 Student Research Committee, Shahid Beheshti University of Medical Sciences Effects of flaxseed and hesperidin in patients with prediabetes Effects of concomitant administration of flaxseed and hesperidin on cardiac and metabolic parameters in patients with prediabetes 2018-01-01 anticipated 48 Complete https://irct.ir/trial/45569 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The random allocation method is simple randomization using a random number table. The unit of allocation is the individual. 3 prediabetes. Intervention 1: Intervention group: lifestyle modification plus combination therapy of brown flaxseed (30 g milled) and hesperidin (two 500 mg capsules). Also, patients were instructed to divide supplements into two equal doses (one capsule of hesperidin and 15 g milled flaxseed), one with breakfast and the other at lunchtime. Intervention 2: Control group: lifestyle modification. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information.
public Zahra Yari
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2235 7483 zahrayari_nut@yahoo.com Shahid Beheshti University of Medical Sciences scientific Zahra Yari
No. 7, Hafezi (Arghavan) St., Farahzadi Ave., Shahrake Ghods(Gharb) town, Tehran, Iran
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2235 7484 zahrayari_nut@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Aged 18 to 70 years Diagnosed with prediabetes Having body mass index (BMI) range of 25 to 40 kg/m2 18 years 70 years Both History of cardiovascular, pulmonary, renal, hepatic and gastrointestinal disease Taking anti-hypertensive, glucose-lowering medications, lipid-modifying agents and omega-3 dietary supplement Being under treatment with steroids and nonsteroidal anti-inflammatory drugs Being on a calorie-restricted regimen within 3 months before the commencement of the trial Being pregnant or lactating R73.01 Impaired fasting glucose Treatment - Other Lifestyle Intervention group: lifestyle modification plus combination therapy of brown flaxseed (30 g milled) and hesperidin (two 500 mg capsules). Also, patients were instructed to divide supplements into two equal doses (one capsule of hesperidin and 15 g milled flaxseed), one with breakfast and the other at lunchtime. Control group: lifestyle modification Weight. Timepoint: Baseline and Week 12. Method of measurement: Scale. Waist circumference. Timepoint: Baseline and Week 12. Method of measurement: Meter. Blood pressure. Timepoint: Baseline and Week 12. Method of measurement: Mercury Sphygmomanometer. Serum concentration of fasting blood sugar. Timepoint: Baseline and Week 12. Method of measurement: Enzymatic method. Serum concentration of fasting blood insulin. Timepoint: Baseline and Week 12. Method of measurement: Enzyme-linked immunosorbent assay (ELISA). Serum concentration of triglyceride. Timepoint: Baseline and Week 12. Method of measurement: Enzymatic method. Serum concentration of HDL. Timepoint: Baseline and Week 12. Method of measurement: Enzymatic method. Serum concentration of LDL. Timepoint: Baseline and Week 12. Method of measurement: Enzymatic method. Serum concentration of hs-CRP. Timepoint: Baseline and Week 12. Method of measurement: Enzyme-linked immunosorbent assay (ELISA). Serum concentration of TNF-alpha. Timepoint: Baseline and Week 12. Method of measurement: Enzyme-linked immunosorbent assay (ELISA). Student Research Committee, Shahid Beheshti University of Medical Sciences Approved 2019-12-29 Ethics Committee of Vice Chancellor of Research, Shahid Beheshti University of Medical Sciences Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)