The aim of this study was to determine the effects of concomitant administration of flaxseed and hesperidin on cardiac and metabolic parameters in patients with prediabetes.
Design
This study was an open-label, randomized controlled clinical trial with two parallel groups. 48 patients were randomly assigned to the intervention and control group.
Settings and conduct
Patients with prediabetes referring to the university outpatient Nutrition Clinic were invited to participate in this research, and the research goals and methods were explained for them. After assessing the entrance criteria and obtaining written consent, 10 cc blood samples are taken. The food recall questionnaire is completed. Supplements are given to patients for a month.
Participants/Inclusion and exclusion criteria
Patients with prediabetes who were not on a diet or medication therapy to lower their blood pressure, blood sugar and lipid profile were enrolled.
Intervention groups
Subjects were randomly assigned to receive lifestyle intervention plus combination therapy of brown flaxseed (30 g milled) and hesperidin (two 500 mg capsules) (intervention group) or lifestyle modification alone
(control group) for 12 weeks.
Main outcome variables
Weight; Waist Circumference; Blood Pressure; Serum concentration of fasting blood sugar; insulin; triglyceride; high-density lipoprotein cholesterol; low-density lipoprotein cholesterol; high sensitive C reactive protein; tumor necrosis factor-alpha
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181120041710N2
Registration date:2020-02-10, 1398/11/21
Registration timing:retrospective
Last update:2020-02-10, 1398/11/21
Update count:0
Registration date
2020-02-10, 1398/11/21
Registrant information
Name
Zahra Yari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2235 7484
Email address
zahrayari_nut@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-01, 1396/10/11
Expected recruitment end date
2018-10-01, 1397/07/09
Actual recruitment start date
2018-01-01, 1396/10/11
Actual recruitment end date
2018-10-01, 1397/07/09
Trial completion date
2018-10-01, 1397/07/09
Scientific title
Effects of concomitant administration of flaxseed and hesperidin on cardiac and metabolic parameters in patients with prediabetes
Public title
Effects of flaxseed and hesperidin in patients with prediabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Aged 18 to 70 years
Diagnosed with prediabetes
Having body mass index (BMI) range of 25 to 40 kg/m2
Exclusion criteria:
History of cardiovascular, pulmonary, renal, hepatic and gastrointestinal disease
Taking anti-hypertensive, glucose-lowering medications, lipid-modifying agents and omega-3 dietary supplement
Being under treatment with steroids and nonsteroidal anti-inflammatory drugs
Being on a calorie-restricted regimen within 3 months before the commencement of the trial
Being pregnant or lactating
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
48
Actual sample size reached:
48
Randomization (investigator's opinion)
Randomized
Randomization description
The random allocation method is simple randomization using a random number table. The unit of allocation is the individual.
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
Ethics Committee of Vice Chancellor of Research, Shahid Beheshti University of Medical Sciences
Street address
Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1467664961
Approval date
2019-12-29, 1398/10/08
Ethics committee reference number
IR.SBMU.RETECH.REC.1398.561
Health conditions studied
1
Description of health condition studied
prediabetes
ICD-10 code
R73.01
ICD-10 code description
Impaired fasting glucose
Primary outcomes
1
Description
Weight
Timepoint
Baseline and Week 12
Method of measurement
Scale
2
Description
Waist circumference
Timepoint
Baseline and Week 12
Method of measurement
Meter
3
Description
Blood pressure
Timepoint
Baseline and Week 12
Method of measurement
Mercury Sphygmomanometer
4
Description
Serum concentration of fasting blood sugar
Timepoint
Baseline and Week 12
Method of measurement
Enzymatic method
5
Description
Serum concentration of fasting blood insulin
Timepoint
Baseline and Week 12
Method of measurement
Enzyme-linked immunosorbent assay (ELISA)
6
Description
Serum concentration of triglyceride
Timepoint
Baseline and Week 12
Method of measurement
Enzymatic method
7
Description
Serum concentration of HDL
Timepoint
Baseline and Week 12
Method of measurement
Enzymatic method
8
Description
Serum concentration of LDL
Timepoint
Baseline and Week 12
Method of measurement
Enzymatic method
9
Description
Serum concentration of hs-CRP
Timepoint
Baseline and Week 12
Method of measurement
Enzyme-linked immunosorbent assay (ELISA)
10
Description
Serum concentration of TNF-alpha
Timepoint
Baseline and Week 12
Method of measurement
Enzyme-linked immunosorbent assay (ELISA)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: lifestyle modification plus combination therapy of brown flaxseed (30 g milled) and hesperidin (two 500 mg capsules). Also, patients were instructed to divide supplements into two equal doses (one capsule of hesperidin and 15 g milled flaxseed), one with breakfast and the other at lunchtime.
Category
Treatment - Other
2
Description
Control group: lifestyle modification
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
University outpatient Nutrition Clinic
Full name of responsible person
Zahra Yari
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2235 7483
Email
info@nnftri.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Student Research Committee, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Amir Mohammad Mortazavian
Street address
Block 2, Shahid Beheshti University of Medical Sciences, Evin Ave.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Student Research Committee, Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Yari
Position
Ph.D student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town