Comparing the effectiveness of yogurt enriched with glucomannan and inulin with regular low-fat yogurt in controlling anthropometric, biochemical and appetite status in overweight and obese type 2 diabetes patients
Determining the effect of dairy products enriched with glucomannan and inulin on some anthropometric, biochemical and appetite indicators in overweight and obese type 2 diabetes patients
Design
This clinical trial has control and intervention groups (with random allocation to each group), parallel groups, double-blind, phase 3 and will be conducted on 80 patients. The block randomization method will be used for randomization
Settings and conduct
Place of study: Diabetes Clinic, Ali Asghar Hospital, Shiraz University of Medical Sciences, Shiraz, Fars.
Study population: people with type 2 diabetes referred to the diabetes clinic of Ali Asghar Hospital, Shiraz University of Medical Sciences.
Yogurts are supplied from the factory in completely identical packages with A and B labels, and the clinical evaluator and patients will be blinded until the end of the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age range from 20 to 60 years; BMI between 25 and 35; willingness to cooperate.
Exclusion criteria:
Participation in weight loss programs during the last 6 months; Change in your physical activity during the last 4 weeks; taking drugs that affect appetite and body weight or have an anti-inflammatory effect; pregnancy; breastfeeding; Rare or chronic diseases
Intervention groups
Control group (A): the group receiving 150 ml of low-fat yogurt once a day + diabetic food recommendations;
Intervention group (B): the group receiving 150 ml of low-fat yogurt enriched with glucomannan and inulin once a day + diabetic dietary recommendations
Main outcome variables
Anthropometric indicators;
Lipid profile;
Glycemic profile;
Body composition;
Malondialdehyde
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230704058672N1
Registration date:2024-06-22, 1403/04/02
Registration timing:prospective
Last update:2024-06-22, 1403/04/02
Update count:0
Registration date
2024-06-22, 1403/04/02
Registrant information
Name
Mohammad Jafar Dehzad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 933 574 4145
Email address
mjdehzad@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-05, 1403/05/15
Expected recruitment end date
2024-09-22, 1403/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of yogurt enriched with glucomannan and inulin with regular low-fat yogurt in controlling anthropometric, biochemical and appetite status in overweight and obese type 2 diabetes patients
Public title
Determining the effect of a dairy product enriched with glucomannan and inulin in type 2 diabetic patients.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age range from 20 to 60 years
Body mass index between 25 -35 kg/m2
If taking medication to control blood sugar and lipid profile, a fixed-dose medication during the entire intervention
Desire to cooperate
Exclusion criteria:
Participation in weight loss programs during the last 6 months (weight loss less than 10% in the last 6 months)
Change in physical activity during the past 4 weeks
Taking drugs that affect appetite and body weight or have an anti-inflammatory effect.
Taking antioxidants or multivitamins and any type of food supplement in the last 3 months
Pregnancy or breastfeeding
Gastrointestinal surgery or weight loss (bariatric) surgery
Smoking cessation in the last 6 months
Kidney disease
History of recurrent kidney stones
Liver dysfunction
Untreated hypertension
History or symptoms of gallstones
Cancer
History of endocrine disorders (especially hypothyroidism)
History of bulimia and/or laxative abuse
Mental disorders or impaired independence
History of alcohol or other drug abuse
Age
From 20 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization of people between two groups is done by block method. In this way, the size of the blocks is considered to be 4 and all possible situations are written for two groups A and B, and this work is repeated until the number reaches 80 people. Then, using the table of random numbers, a number is given to each of the components of the blocks. The numbers given to each of the components of the blocks represent the number considered for each person, which has been determined in advance. As a result, the group attributed to each person is determined. The sequence allocation is done by the consultant professor and the grouping of people will remain hidden for the patient and clinical evaluators until the end of the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
The manufactured product with completely identical packaging and characteristics and under A and B labels will reach the clinical care provider from the factory. The participants are also randomly placed in two product consumption groups A and B and will not be in contact with each other during the study. In the examination process, the clinical caregiver evaluates and records the results only with the code of the consumed product, and finally the results are sent confidentially and coded for analysis.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Karimkhan Zand Blvd.
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2024-04-15, 1403/01/27
Ethics committee reference number
IR.SUMS.MED.REC.1403.038
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Body weight
Timepoint
At the beginning of the study and after 60 days of using the product
Method of measurement
InBody scale and body analyzer
2
Description
Fasting blood sugar
Timepoint
At the beginning of the study and after 60 days of using the product
Method of measurement
Laboratory test
3
Description
Glycosylated blood sugar (HbA1c)
Timepoint
At the beginning of the study and after 60 days of using the product
Method of measurement
Laboratory test
4
Description
Waist circumference
Timepoint
At the beginning of the study and after 60 days of using the product
Method of measurement
Inflexible meter - the measurement between the iliac crest and the last rib in the standing position
5
Description
Hip circumference
Timepoint
At the beginning of the study and after 60 days of using the product
Method of measurement
Inflexible meter - the measurement of the circumference of the hips from the most prominent point of the hips in a standing position
6
Description
Body composition
Timepoint
At the beginning of the study and after 60 days of using the product
Method of measurement
InBody Body Analyzer (BIA)
7
Description
Lipid profile
Timepoint
At the beginning of the study and after 60 days of using the product
Method of measurement
Laboratory test
8
Description
Malondialdehyde (MDA)
Timepoint
At the beginning of the study and after 60 days of using the product
Method of measurement
Laboratory test
9
Description
Serum Adiponectin
Timepoint
At the beginning of the study and after 60 days of using the product
Method of measurement
Laboratory test
10
Description
Serum Leptin
Timepoint
At the beginning of the study and after 60 days of using the product
Method of measurement
Laboratory test
Secondary outcomes
empty
Intervention groups
1
Description
Control group: People in this group will consume a 150-gram portion of normal low-fat yogurt daily for 8 weeks, before lunch. Yogurt will be supplied by Zarin Ghazal (Daiti) Company of Shiraz. Training for the control group will be done by a nutritionist with the focus on "Education of proper diet in diabetes".
Category
Placebo
2
Description
Intervention group: People in this group will consume a 150-gram portion of low-fat yogurt enriched with 1.5 grams of glucomannan and 1.5 grams of inulin daily for 8 weeks, before lunch. Yogurt will be supplied by Zarin Ghazal (Daiti) Company of Shiraz. The intervention group will be trained by a nutritionist with the focus on "Education on proper diet in diabetes".
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Clinic
Full name of responsible person
Mohammad Jafar Dehzad
Street address
Namazi Sq.
City
Shiraz
Province
Fars
Postal code
۷۱۳۴۸۱۴۷۳۴
Phone
+98 71 3212 7000
Email
mj.dehzad@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Siavash Babajafari
Street address
Nutrition and Food Sciences School, Razi Blvd.
City
Shiraz
Province
Fars
Postal code
7153675500
Phone
+98 71 3725 1001
Email
scnutrition@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Jafar Dehzad
Position
PhD Candidate
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Nutrition and Food Sciences School, Razi Blvd.
City
Shiraz
Province
Fars
Postal code
7153675500
Phone
+98 71 3725 1001
Email
mj.dehzad@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Jafar Dehzad
Position
PhD Candidate
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Nutrition and Food Sciences School, Razi Blvd.
City
Shiraz
Province
Fars
Postal code
7153675500
Phone
+98 71 3725 1001
Email
mj.dehzad@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Jafar Dehzad
Position
PhD Candidate
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Nutrition and Food Sciences School, Razi Blvd.
City
Shiraz
Province
Fars
Postal code
7153675500
Phone
+98 71 3725 1001
Email
mj.dehzad@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after study completion and de-identification of individual participants
When the data will become available and for how long
Access starts 3 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions in related fields