Effect of Brewers yeast on glycosylated hemoglobin, insulin resistance, insulin sensitivity and blood pressure in patients with type 2 diabetes mellitus
In a double-blind placebo-controlled clinical trial aimed to determine the effects of brewers yeast supplementation on insulin resistance, insulin sensitivity, glycosylated hemoglobin and blood pressure in type 2 diabetic patients, 80 patients (63 women and 21 men) with a history of diabetes for at least 2 years, aged 35-55 years, without any record of hepatitis, cardiovascular, renal and Parkinson's diseases, gout and depression disorder in the last year were randomly selected from those referring to the Dezful ganjavian diabetes clinic. They were divided into 2 groups by ABAB blockes based on sex and glycosylated hemoglobin. Participants of the brewer’s yeast group received 1800 mg Brewer's yeast (two 300 mg tablets three times daily) and placebo group received equal quantities of pills containing excipient without brewer’s yeast for the same period of time. Initial and final blood pressure were measured. Moreover, fasting blood samples were taken at baseline and after 12 weeks to be analyzed for glycemic indices and serum lipoprotein .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138807062513N1
Registration date:2012-07-25, 1391/05/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-07-25, 1391/05/04
Registrant information
Name
Payam Hoseinzadeh
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8895 4911
Email address
p_hoseinzadeh@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor for Research, Tehran University of Medical Sciences
Expected recruitment start date
2009-11-22, 1388/09/01
Expected recruitment end date
2010-03-11, 1388/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Brewers yeast on glycosylated hemoglobin, insulin resistance, insulin sensitivity and blood pressure in patients with type 2 diabetes mellitus
Public title
Effect of Brewers yeast on blood glucose level and blood pressure in patients with type 2 diabetes mellitus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: History of at least 2 years clinically diagnosed type 2 diabetes mellitus; taking oral hypoglycemic drugs ; Fasting blood glucose at least more than 125 mg/dl; Not consuming brewers yeast during the last 3 months; Aged 35-55 years; Signing the informed consent form (attached). Exclusion criteria: History of hepatitis, cardiovascular, renal and Parkinson's diseases, gout and depression disorder, A record of angina pectoris, myocardial and cerebral infarction during the last year; History of infectious disease or common cold during the last 4 weeks; Regular consumption of anti-inflammatory drugs (steroid or non-steroid) or monoamine oxidase inhibitors; Insulin therapy; Consumption of brewers yeast or placebo less than 12 weeks; Any side effects due to supplementation; Change in diet or hypoglycemic drugs; Unwilling to continue taking supplementation.
Age
From 35 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences Ethics Committee
Street address
Keshavarz Blvd., Corner of Ghods St.
City
Tehran
Postal code
Approval date
2010-03-02, 1388/12/11
Ethics committee reference number
45951
Health conditions studied
1
Description of health condition studied
Non-insulin-dependent diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Fasting Blood Sugar
Timepoint
Baseline, After 12 weeks
Method of measurement
Blood Analysis: GOD / PAP method
2
Description
Glycosylated hemoglobin
Timepoint
Baseline, After 12 weeks
Method of measurement
Blood Analysis: boronate affinity assay
3
Description
HOMA-IR (homeostatic model assessment of insulin resistance)