Assessment of the effect of oral pyridoxine hydrochloride supplement on anthropometric measurements, body composition, visceral adiposity index, glycemic and lipidemic risk factors and serum levels of leptin and adiponectin in obese and overweight women

Determination of the effect of oral pyridoxine hydrochloride supplement on anthropometric measurements, body composition, visceral adiposity index, glycemic and lipidemic risk factors and serum levels of leptin and adiponectin in obese and overweight women

The present study is a clinical trial of phase 3, randomized, double blind and parallel, which will be done on 44 obese and overweight women who have criteria for entering the study. Patients would be randomly allocated to the intervention or control groups using random number tables and each participant is being assigned a code.

This study will be carried out on Ahvaz medical personnel. At the beginning and the end of the study, anthropometric measurements, body composition and visceral fat index are examined and Fasting blood samples are also taken to determine glycemic and lipidemic profile and serum leptin and adiponectin levels. Diet and physical activity are recorded by the 24-hour recall and the International Physical Activity Inventory.

Inclusion criteria: female; age between 18-50 years old; body mass index is over 25 kg / m2; no changes in weight over 5 kg over the past 3 months; no history of diabetes, cardiovascular, brain, kidney, liver, respiratory, digestive, thyroid; do not use drugs that affect lipid profile and blood glucose and contraception and supplements including antioxidants, minerals, omega 3 and B6. Exclusion criteria: lack of patient collaboration at each stage of intervention; pregnancy during intervention; identify any of the diseases or use the drugs mentioned; start a weight loss die.

Intervention group: pyridoxine hydrochloride Supplement, 2 pills 40 mg per day for 8 weeks. Control group: placebo, starch, 2 pills 40 mg per day for 8 weeks.

Fasting Glucose; insulin; insulin resistance; lipid profile; serum leptin and adiponectin

Simple (assigning a person to a particular group completely randomly) using a random number table

The type of blindness in our study will be double-blind. Prior to the onset of the study, the box containing the relevant pills are coded A and B by an individual except the researcher, in order to blind the researcher about which supplement each group received. When delivering supplements to patients, some one except the researcher should locate the patient in either A or B group by random number table. In this study, the patients and researcher (who collecting data, assessing the outcome and analyzing the data) should be kept blind.