Study design and participants
The Table for allocating individuals to the intervention and control groups was prepared by the statistical consultant using a statistical syntax written in software SPSS. First, all cases of diabetic patients that referred to Shahroud Diabetes Clinic in Northeastern Iran were examined, and then 170 patients with diabetes were called by telephone. Among them, 60 patients were excluded due to lack of the study inclusion criteria. Patient registration with the study inclusion and exclusion criteria was performed by the corresponding author between 2019 and 2020. After explaining the objectives and the method of conducting the study and obtaining informed consent, the patients were assigned to two intervention and control groups by the corresponding author, respectively. Data collection and management was performed by two nurses and a public health student who were masked about the allocation of patients. For increasing participation of subjects, first educational brochures were provided to both groups, including information on the risk factors for diabetes, hyperlipidemia, and how to diagnose, control, and treat the role of diet, especially antioxidants, in reducing the risk. The content of the educational brochures was prepared and reviewed by reviewing the literature according to the opinion of experts.
Declarations
Ethical considerations:
This study has been approved by the Ethics Council in Medical Sciences Research of Shahroud University of Medical Sciences with the code IR.SHMU.REC.1397.200, has been registered in the Iranian clinical trial system with the code IRCT2011309006010N1 and in accordance with the Helsinki Declaration of 1975, as revised in 2008.
Participants
Inclusion and exclusion criteria
The study inclusion criteria included diabetic patients (known as diabetes or fasting blood sugar ≤ 125mg/dl, BS ≥ 200mg/dl, glycosylated hemoglobin %HbA1c > 6.5 and / or treated with oral hypoglycemic medicines referred to Shahroud diabetes clinic.
Exclusion criteria
The study exclusion criteria included diabetic patients treated with insulin or diabetic patients with: cardiovascular, renal, and hepatic disorders, hypothyroidism and seizures; a history of kidney and bladder stones; treated with estrogen, steroid, beta and thiazide inhibitors; women who decided to become pregnant; pregnant women, women who breast feed, users of E and C supplements, and omega-3s at least six months before sampling, smoking and drug users.
Intervention
The members of the intervention group received bulk bread containing Portulaca Oleracea for 4 weeks without considering a special diet, and was followed up by telephone every week. and the control group used ordinary daily bread.
During the study, 4 patients were excluded from the control group for a number of reasons (one patient due to pregnancy, one patient due to arrhythmia, one patient due to hypothyroidism, and one patient due to drug abuse and addiction) and a patient was excluded from the intervention group due to drug abuse during the intervention. Finally, the data of 104 patients (54 patients in the intervention group and 51 patients in the control group) were analyzed (Fig. 1). Regarding the nature of the study, it was not possible to blind participants, but the data collector and analyst were unaware of how patients were allocated to the two groups.
Bread preparation containing Portulaca Oleracea
All parts of Portulaca Oleracea, which included leaves, stems and seeds, were collected in Shahroud in the summer of 2019, and after preparing the powder, 10% was added to wheat flour. The cooled produced bread was then evaluated by 20 trained evaluators (10 males and 10 females). The sensory properties examined in this study included taste, texture, color, odor, and general acceptance [39]. The bread was then packed in polyethylene bags and distributed to several members of the intervention group on a daily basis at several distribution centers [40] and became necessary recommendations for eating were reminded by phone.
Assessments and outcomes
Primary outcomes.
After obtaining written consent, the subjects completed a questionnaire on demographic information including (age, diabetes years, sex, job, family history diabetic, Married Statues, Family size, Level of education, Oral Contraceptive Pills DM Consumption) and, after 12 hours of fasting, venous blood samples also blood sugar 2 hours later were collected from all the participants and the serums were stored at 70 degrees below zero. Enzymatic assay method and Pars Azmoon Kit were used to perform all tests including fasting blood Sugar (FBS), blood sugar (BS), triglycerides (TG), total cholesterol(Chol), LDL, HDL and glycosylated hemoglobin (HbA1c) was done by analyzer Drew-DSS with the chromatography HPLC method.
Secondary outcomes
Fasting blood sugar, triglyceride, total cholesterol, LDL, and HDL after intervention by enzymatic method and Pars Azmoon reagent, Iran. were performed on all candidates after 12 hours of fasting and 2 hours later blood. and HbA1c was measured by Drew-DS5 analyzer and DS5 Pink Reagent kit. after the intervention.
sample size
The sample size in this study was determined according to the objectives of the study and using Sabzghabaee et al.'s study with the default of the first type error less than 0.05, 80% test power. the estimated sample size was n = 38 in each group[29]. With regard of missing value and increasing of power of study, finally the number of samples in each group was n = 55.
The data were collected using demographic information form as well as experiments. The form of demographic information included age, gender, number of household members, level of education, occupation, marital status, type of medicines used, and the onset of diabetes completed by patients before the intervention in both groups.
Randomization
The present study is a parallel randomized clinical trial. In this interventional study, 104 patients with diabetes referred to Shahroud Diabetes Clinic in Iran. based on the study inclusion and exclusion criteria and after explaining the objectives of the study and obtaining informed consent, were selected. They were randomly assigned to intervention and control group based on permuted block random allocation (block size of 4).
Statistical methods
To analyze the data, we used descriptive statistics (mean, and standard deviation) and the effectiveness of the intervention method was compared with the difference between the mean before and after the intervention (change score) in the two groups using t-test. Using SPSS and Stata software, data analysis was performed at a significant level of 0. 05.