The effect of whole grains versus refined grains on fasting blood sugar in adults with impaired glucose tolerance: An unblinded, randomized, and crossover controlled trial.
To compare the effect of whole bread versus refined bread on fasting blood sugar in adults with syndrome metabolic.
Design
An unblinded, randomized, and crossover controlled trial.
Settings and conduct
A one-week run-in period will be conducted and then participants will be randomized using block balanced randomization of a four-block size via computer-generated randomization and allocated to an intervention group(A) and a comparison group(B). There are two 3-month treatment periods separated by a 4-week washout and then the intervention and comparison groups will swap places for an additional twelve weeks. The study will be implemented at the Diabetes Clinic of Tehran University in Tehran, Iran.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Adults aged 25-64 who consume refined grains as part of their habitual diet and can be defined as metabolic syndrome patients based on the updated National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATP III) criteria and displaying three of the conditions below :
1) Abdominal obesity as defined as a waist circumference in women ≥80 cm and in men ≥94 cm based on the cutoff measurements of the Middle East (31)
2) Serum triglycerides ≥150 mg/dl (1.7mmol/l)
3) Serum high-density lipoprotein (HDL) cholesterol <40 mg/dl (1 mmol/L) in men and <50 mg/dl (1.3 mmol/l) in women
4) Blood pressure ≥130/85 mmHg
5) Fasting plasma glucose (FPG) between 100-125mg/dl (5.6-6.9) mmol/l
Exclusion criteria:
• Individuals with a history of diabetes, cardiovascular diseases, cancer, kidney disease, gastrointestinal conditions or celiac disease.
• Women who are pregnant or breast-feeding women
Intervention groups
The daily intake of rice and bread of each participant will be calculated based on the FFQ. Half of their serving of bread and rice will be replaced with whole wheat flatbread per day.
Main outcome variables
FBS
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160111025947N2
Registration date:2018-05-09, 1397/02/19
Registration timing:registered_while_recruiting
Last update:2018-05-09, 1397/02/19
Update count:0
Registration date
2018-05-09, 1397/02/19
Registrant information
Name
Fatemeh Kazemi
Name of organization / entity
School of Nutrition Sciences and Dietetics Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8895 5975
Email address
f_kazemi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2018-06-21, 1397/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of whole grains versus refined grains on fasting blood sugar in adults with impaired glucose tolerance: An unblinded, randomized, and crossover controlled trial.
Public title
Whole grain in metabolic syndrome
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
1) Abdominal obesity as defined as a waist circumference in women ≥80 cm and in men ≥94 cm based on the cutoff measurements of the Middle East (31)
2) Serum triglycerides ≥150 mg/dl (1.7mmol/l)
3) Serum high-density lipoprotein (HDL) cholesterol <40 mg/dl (1 mmol/L) in men and <50 mg/dl (1.3 mmol/l) in women
4) Blood pressure ≥130/85 mmHg
5) Fasting plasma glucose (FPG) between 100-125mg/dl (5.6-6.9) mmol/l
6) 25-64 years old
Exclusion criteria:
• Individuals with a history of diabetes,
Individuals with a history of cardiovascular diseases,
Individuals with a history of cancer,
Individuals with a history of kidney disease,
Individuals with a history of lower gastrointestinal conditions
Individuals with a history of celiac disease.•
Individuals taking medications which could influence lipid metabolism except for low- intensity Statin therapy,
Individuals taking medications which could influence glucose metabolism except for Metformin up to 1000mg/day
Individuals taking medications which could influence blood pressuer except for losartan up to 25mg/day
Women who are pregnant or may become pregnant during the duration of the study
breast-feeding women
Age
From 25 years old to 64 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
using block balanced randomization of a four-block size via computer-generated randomization (Microsoft Excel 2010).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Non-communicable Disorders Research Center of Endocrinology and Metabolism Research Institute, Tehra
Street address
No 10, Jalal al ahmad Alley,tehran
City
Tehran
Province
Tehran
Postal code
1411713119
Approval date
2015-10-13, 1394/07/21
Ethics committee reference number
IR.tums.EMRI.Rec.1394.23
Health conditions studied
1
Description of health condition studied
Metabolic Syndrome
ICD-10 code
E88.9
ICD-10 code description
Metabolic disorder, unspecified
Primary outcomes
1
Description
Fasting blood sugar
Timepoint
before intervention and 3,4,7 months after intervention
Method of measurement
by Glucose oxidase method
Secondary outcomes
1
Description
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Timepoint
At the beginning of the study(before starting intervention), 3, 4,7 months after the intervention.
Method of measurement
by the following formula: (fastinginsulin (μU/ml)) × fasting glucose (mmol/l))/22.5)
2
Description
Plasma Total Cholesterol/HDL-C
Timepoint
At the beginning of the study(before starting intervention), 3, 4,7 months after the intervention.
Method of measurement
by the formula
3
Description
Triglyceride
Timepoint
At the beginning of the study(before starting intervention), 3, 4,7 months after the intervention.
Method of measurement
enzymatic method
4
Description
Total Cholesterol
Timepoint
At the beginning of the study(before starting intervention), 3, 4,7 months after the intervention.
Method of measurement
Enzymatic method
5
Description
Fasting plasma Insulin
Timepoint
At the beginning of the study(before starting intervention), 3, 4,7 months after the intervention.
Method of measurement
Elisa
6
Description
postprandial Insulin
Timepoint
At the beginning of the study(before starting intervention), 3, 4,7 months after the intervention.
Method of measurement
Elisa
7
Description
Postprandial glucose
Timepoint
At the beginning of the study(before starting intervention), 3, 4,7 months after the intervention.
Method of measurement
Glucose oxidase method
8
Description
High sensitivity C-reactive protein concentration(hs-CRP)
Timepoint
At the beginning of the study(before starting intervention), 3, 4,7 months after the intervention.
Method of measurement
Turbidimetric method
9
Description
Interleukin1(IL1)
Timepoint
At the beginning of the study(before starting intervention), 3, 4,7 months after the intervention.
Method of measurement
Enzymatic method
10
Description
Interleukin6(IL6)
Timepoint
At the beginning of the study(before starting intervention), 3, 4,7 months after the intervention.
Method of measurement
Enzymatic method
11
Description
Tumor Necrosis Factor-∝(TNF-∝),
Timepoint
At the beginning of the study(before starting intervention), 3, 4,7 months after the intervention.
Method of measurement
ELISA
12
Description
Hemoglobin A1c
Timepoint
At the beginning of the study(before starting intervention), 3, 4,7 months after the intervention.
Method of measurement
HPLC
13
Description
weight
Timepoint
At the beginning of the study(before starting intervention), 3, 4,7 months after the intervention.