Effect of simple dietary advice or a low calorie diet program supplemented with psyllium on glycemic control and inflammatory cytokines in patients with type 2 diabetes
Objectives: To examine the impact of simple dietary advice or a structured low-calorie diet program on glycemic control, lipid profile and inflammatory cytokines in patients with type 2 diabetes.
Design: This is an open randomized controlled trial with two parallel groups. Thirty-six diabetic patients will be randomized into two groups: 1-Diet program (diet group), 2- Simple nutrition advice (advice group).
Participants: Type 2 diabetic patients that are not using insulin and have no history of diabetic retinopathy.
Setting and conduct: Participants will be followed for 8 weeks. Fasting and 2-hour postprandial (after a standard breakfast) venous blood samples will be taken at baseline and after 8 weeks of dietary modification. Dietary compliance will be assessed through 24-hour dietary recall.
Intervention: In the advice group, patients are given simple dietary advice on single occasion aimed to modulate carbohydrate intake (to reduce consumption of simple sugars and foods containing added simple sugars, avoidance of overeating too much refined carbohydrate and replacement with whole grain foods). In diet group, diet program will be developed for each patient based on anthropometric, dietary and physical activity assessments with energy intake deficits of 25% of total calculated energy requirements. In this group, macronutrient distribution will be 55%from carbohydrate, 25% fat, and 20% protein. In addition, patients will be instructed to ingest a tablespoon of psyllium powder dissolved in one glass of water at the evening.
Main outcome measures: Plasma concentrations of glucose, insulin.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016070228742N1
Registration date:2016-09-30, 1395/07/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-09-30, 1395/07/09
Registrant information
Name
Javad Nasrollahzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2236 0656
Email address
jnasrolah@razi.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2016-08-06, 1395/05/16
Expected recruitment end date
2016-10-08, 1395/07/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of simple dietary advice or a low calorie diet program supplemented with psyllium on glycemic control and inflammatory cytokines in patients with type 2 diabetes
Public title
Dietary modification and diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Type 2 diabetics; body mass index< 29,
Exclusion criteria: Using insulin; history of diabetic nephropathy
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Nutrition and Food Technology Ethics Committee
Street address
Shahid Beheshti University of Medical Sciences
City
Tehran
Postal code
Approval date
2015-01-13, 1393/10/23
Ethics committee reference number
054559
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Plasma glucose and insulin
Timepoint
Baseline and after 8 weeks
Method of measurement
Colorimetry and elisa
Secondary outcomes
1
Description
Plasma lipids and inflammatory cytokines
Timepoint
Baseline and at the end of study
Method of measurement
Colorimetry and ELISA
Intervention groups
1
Description
Hypocaloricdiet program plus a tablespoon psyllium powder
Category
Lifestyle
2
Description
Simple dietary advice including to reduce consumption of simple sugars and refined carbohydrates
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Nutrition Clinic in Faculty of Nutrition, Shahid Beheshti University of Medical Science