1. Home
  2. Approved trials
  3. » فارسی

The effect of Vanadium enriched yeast on anthropometric indices, quality of life, glycemic control, lipid profile, and gene expression of PTP1B, PTEN, MAPK, S6K and NFƘB in obese adult patients with type II Diabetes

Protocol summary

Study aim
Assessing the effect of Vanadium enriched yeast on anthropometric indices, quality of life, glycemic control, lipid profile, and gene expression of PTP1B, PTEN, MAPK, S6K and NFƘB in obese adult patients with type II Diabetes
Design
This is a parallel, randomized, double-blind, placebo controlled clinical trial.
Settings and conduct
A structured questionnaire for collecting demographic information, 24 hr food recall and physical activity level. Anthropocentric indices will be measured. The patients will randomly assign to two groups, intervention group receiving vanadium enriched yeast capsules and control group consuming yeast capsules for 12 weeks. For biochemical measurements, fasting blood samples will be gathered. Statistical analysis will be performed using SPSS.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Willing to participate in the study. Age range of 30-60 years. Diagnosed with type 2 diabetes. BMI in the range of 30-40 kg/m2. Consuming blood glucose lowering drugs. Exclusion criteria: Unwilling to participate in the study. Diagnosed with other malignancies. Consuming insulin. Changing the type or dose of drugs during the trial. Consuming dietary supplements or complementary therapies. Diagnosed with COVID-19 during the trial. Pregnancy, lactation and menopause. Using opiates and alcohol. Using corticosteroids, NSAID and hormone drugs. Having a special diet.
Intervention groups
The 44 diabetic patients will randomly assign to intervention group (vanadium enriched yeast capsules) and control group (yeast capsules).
Main outcome variables
Quality of life, physical activity, weight, height, BMI, waist circumference, Fat percentage, fasting blood glucose, insulin, insulin resistance, HbA1C, lipid profile, expression rate of MAPK, PTEN, PTP1B, S6k and NFƘB.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211207053312N1
Registration date: 2021-12-12, 1400/09/21
Registration timing: prospective

Last update: 2021-12-12, 1400/09/21
Update count: 0
Registration date
2021-12-12, 1400/09/21
Registrant information
Name
Faezeh Ghalichi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3320 1148
Email address
faezeh.ghalichi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-21, 1400/11/01
Expected recruitment end date
2022-02-20, 1400/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Vanadium enriched yeast on anthropometric indices, quality of life, glycemic control, lipid profile, and gene expression of PTP1B, PTEN, MAPK, S6K and NFƘB in obese adult patients with type II Diabetes
Public title
Vanadium enriched yeast for type II Diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willing to participate in the study. Patients in the age range of 30-60 years, except for menopause women. Diagnosed with type 2 diabetes. Not having other malignancies. Having BMI in the range of 30-40 kg/m2. Consuming blood glucose lowering drugs.
Exclusion criteria:
Unwilling to participate in the study. Diagnosed with renal, hepatic, heart, rheumatic, inflammatory, intestine and other types of diabetes. Consuming insulin. Changing the type or dose of drugs during the trial. Consuming dietary supplements or complementary therapies, one month prior to trial beginning. Diagnosed with COVID-19 during the trial. Being in special physiologic situation such pregnancy, lactation and menopause. Using opiates and alcohol. Using corticosteroids, NSAID and hormone drugs, 6 months prior to trial beginning. Having a special diet, 6 months prior to trial beginning.
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization will be used for each person by random numbers. Due to proper allocation concealment, trial investigators and participants will be unaware of upcoming allocations.
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double-blind study and both of the patients and researcher will be blind to group allocation.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Attar Neishaburi Ave, Golgasht Ave, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5157743856
Approval date
2021-10-25, 1400/08/03
Ethics committee reference number
IR.TBZMED.REC.1400.709

Health conditions studied

1

Description of health condition studied
Diabetes type 2
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus

Primary outcomes

1

Description
weight
Timepoint
before and 12 weeks after the intervention
Method of measurement
scale

2

Description
height
Timepoint
before and 12 weeks after the intervention
Method of measurement
stadiometer

3

Description
Body Mass Index
Timepoint
before and 12 weeks after the intervention
Method of measurement
Estimation

4

Description
Fat percentage
Timepoint
before and 12 weeks after the intervention
Method of measurement
Tanita scale

5

Description
Waist Circumference
Timepoint
before and 12 weeks after the intervention
Method of measurement
mounted tape

6

Description
Quality of life
Timepoint
before and 12 weeks after the intervention
Method of measurement
Diabetes Quality Of Life Questionnaire

7

Description
fasting blood sugar
Timepoint
before and 12 weeks after the intervention
Method of measurement
Enzymatic

8

Description
2hours postprandial blood glucose
Timepoint
before and 12 weeks after the intervention
Method of measurement
Enzymatic

9

Description
HbA1C
Timepoint
before and 12 weeks after the intervention
Method of measurement
Spectrophotometry

10

Description
Fasting insulin
Timepoint
before and 12 weeks after the intervention
Method of measurement
enzyme-linked immunosorbent assay

11

Description
HOMA1-IR
Timepoint
before and 12 weeks after the intervention
Method of measurement
formula

12

Description
HOMA2-IR
Timepoint
before and 12 weeks after the intervention
Method of measurement
Computer software

13

Description
total cholesterol
Timepoint
before and 12 weeks after the intervention
Method of measurement
Enzymatic

14

Description
Triglyceride
Timepoint
before and 12 weeks after the intervention
Method of measurement
Enzymatic

15

Description
High-density lipoprotein (HDL) cholesterol
Timepoint
before and 12 weeks after the intervention
Method of measurement
Enzymatic

16

Description
Low Density Lipoprotein, Cholesterol (LDL-C)
Timepoint
before and 12 weeks after the intervention
Method of measurement
formula

17

Description
expression rate of Protein Tyrosine Phosphatase 1B (PTP1B)
Timepoint
before and 12 weeks after the intervention
Method of measurement
Real Time-Polymerase chain reaction

18

Description
expression rate of Phosphatase and tensin homolog (PTEN)
Timepoint
before and 12 weeks after the intervention
Method of measurement
Real Time-Polymerase chain reaction

19

Description
expression rate of mitogen-activated protein kinase (MAPK or MAP kinase)
Timepoint
before and 12 weeks after the intervention
Method of measurement
Real Time-Polymerase chain reaction

20

Description
expression rate of S6 kinase (S6K)
Timepoint
before and 12 weeks after the intervention
Method of measurement
Real Time-Polymerase chain reaction

21

Description
expression rate of Nuclear factor kappa-light-chain-enhancer of activated B (NFKB)
Timepoint
before and 12 weeks after the intervention
Method of measurement
Real Time-Polymerase chain reaction

Secondary outcomes

1

Description
Energy and Macro-nutrient intake
Timepoint
before and 12 weeks after the intervention
Method of measurement
Questionnaire

2

Description
Physical activity
Timepoint
before and 12 weeks after the intervention
Method of measurement
short form-IPAQ

Intervention groups

1

Description
Intervention group: Vanadium enriched yeast, 150 mg capsule, 2 per day, for 12 weeks
Category
Treatment - Drugs

2

Description
Control group: yeast, 150 mg capsule, 2 per day, for 12 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabriz Diabetes Association
Full name of responsible person
Faezeh Ghalichi
Street address
Attar Neishaburi Ave, Golgasht Ave, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5157743856
Phone
+98 41 3335 7584
Email
faezeh.ghalichi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ahmadi
Street address
Nutrition Faculty, Tabriz University of Medical Sciences, Attar Neishaburi Ave, Golgasht Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7584
Email
faezeh.ghalichi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Faezeh Ghalichi
Position
PhD student of Nutrition
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Nutrition and food sciences faculty, Attar Neishaburi Ave, Golgasht Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5157743856
Phone
+98 41 3335 7584
Email
faezeh.ghalichi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Alireza Ostadrahimi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nutrition and food sciences Faculty, Attar Neishaburi Ave, Golgasht Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7584
Email
ostadrahimi@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Faezeh Ghalichi
Position
Phd Student of Nutrition
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Nutrition and food sciences Faculty, Attar Neishaburi Ave, Golgasht Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5157743856
Phone
+98 41 3335 7584
Email
faezeh.ghalichi@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
All data are resulting from dissertation and will be used just for manuscript printing in academic journals.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Loading...