Effect date seed (Phoenix dactylifera L) coffee extract on blood sugar control in type 2 diabetic patients

Effect of date seed coffee extract on blood sugar control in type 2 diabetic patients

This triple-blind, phase 2 clinical trial is performed in 100 type II diabetic patients divided equally in herbal and placebo groups. Herbal medicine and placebo with code A or B, are prescribed to patients for 3 months. Physician, nurse, patients, data collector and who evaluate the outcome are unaware of the drug and placebo group. Only laboratory expert knows the types of the groups.

Type 2 diabetic patients referred to the Diabetes Clinic of Imam Ali Hospital, affiliated to Alborz University of Medical Sciences, were selected and randomly divided into two groups. After the visit, the patients is selected and enrolled in the study by the endocrinologist if they meets the inclusion criteria the study. After being selected, the patient is referred to the laboratory for tests including fasting blood sugar, HbA1C, Lipid profile, SGOT, SGPT, CBC, and Creatinine. The patients are given herbal or placebo capsule boxes with an identification code of A or B and will be monitored for 3 months for any side effects. Patients will repeat the above tests at the end of the study.

Patients with mild to moderate type 2 diabetes, age 40 to 60 years, have diabetes for at least two years, under treatment with or without anti-diabetic drugs, fasting blood glucose levels between 130 to 170 mg/dL, glycosylated hemoglobin between 7.5 to 8.5%

Herbal drug group: Patients in this group receive a 500 mg capsule of date seed coffee extract twice a day after food. Placebo group: Patients in this group receive a 500 mg capsule of toasted powder twice a day after food.

Fasting blood glucose Glycosylated hemoglobin

For randomization, a random number table and block randomization method is used. In this method the patients are assigned into blocks of 2 patients (total 30 blocks). Then, each of the 2 patients entered the block of herbal drug or placebo, with 30 patients assigned to each group. There is no significant difference in fasting blood glucose and glycosylated hemoglobin in each group.

Package for herbal and placebo is labeled with code B or A. Other specifications on the labels are identical. Physicians, nurses, patients, data collectors and those who evaluate the outcome are unaware of the drug and placebo group. Only laboratory expert knows the types of the groups. Patients are aware that they are either in the herbal drug or placebo groups, but they are not aware of the type of group they are in.