The effect of bitter almond gum supplement on the metabolic, inflammatory, and mental health indicators in women with type 2 diabetes

The effect of bitter almond gum supplement on the status of metabolic, inflammatory and mental health indicators in women with type 2 diabetes

Clinical trial with control group, with parallel groups, Triple-blind, randomized, phase 3 on 44 patients. Randomized block software was used for randomization.

This clinical trial will be performed on patients referred to the Iranian Diabetes Association and hospitals affiliated to Tabriz University of Medical Sciences. Screened patients will be randomly divided into two groups of intervention and control. Coded supplements will be distributed to patients in similar packaging. The intervention group will received bitter almond gum and the control group will received maltodextrin for 2 months .

Inclusion criteria were: having type 2 diabetes for more than six months, using anti-diabetic drugs and maintaining them in the period of the study, and having a normal diet and Body Mass Index of more than 25 kg/m2 in the last 3 months. Type 2 diabetes was defined as a fasting plasma glucose level of more than 126 mg/dl. Patients were excluded if they had a history of gastrointestinal; cardiovascular; renal; thyroid; liver; or pancreatic diseases; if they were pregnant; smokers; lactating; consuming pre/probiotics’ products; antibiotics; antiacids; alcohol; anti-diarrheal; anti-inflammatory; lipid-lowering; laxatives or insulin; and finally if they had a typical fiber intake more than 30g/d

The intervention group will receive a 10g/d bitter almond gum supplement for 8 weeks. The control group will receive a 10g/d maltodextrin for 8 weeks.

cytokines (IL1,6,17,10, TNF), adipokines (leptin, adiponectin, ghrelin), GLYCEMIC INDICES (HbA1c, FBS, INSULIN), Lipid profile, antioxidant/oxidative stress biomarkers, mental health, LPS, CD4/CD8

Participants in the study will be divided into two groups using balanced block randomization: 1) bitter almond gum consumer 2) placebo consumer. First, the quadruple Blocks and arrangement of blocks with their numbering will be determined. Then after the selection of specific blocks using a random number table and based on the number of blocks, entering the first four participants will be done. Then again, determination of the next block will be done using the random number table and this will continue until we reach the specified sample size.

Bitter almond gum and maltodextrin (Both have the same taste, color, and smell) were delivered to patients monthly in similar cellophanes and unrecognizable without mentioning the type of supplement on the packages. In order to separate the two types of powders, in the factory, using a digital device, the code and date of production and expiration will be printed on the packages. In order for the researcher to be unaware of the patient's treatment, distribution of supplements, and placebo by another person Codes and type of supplement not known will be done. Until the study results are released, the patient, researcher, and data analyzer will not know the assigned codes.

Participant data will be presented in the article without identifiable details

2020-2021

Tabriz University of Medical Sciences

The application must be submitted to Tabriz University of Medical Sciences. It will available if Tabriz University of Medical Sciences is allowed.

Tabriz University of Medical Sciences

The application must be submitted to Tabriz University of Medical Sciences. It will available if Tabriz University of Medical Sciences is allowed.