Back to resultsThe Effects of Hesperidin and Flaxseed in Prediabetes
Primary Purpose
PreDiabetes
Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
hesperidin and flaxseed
control
Sponsored by
About this trial
This is an interventional treatment trial for PreDiabetes
Eligibility Criteria
Inclusion Criteria:
- Age of 18 to 70 years prediabetes: impaired fasting glucose (>100 mg/dL) and/or HbA1C 5.7% to 6.5%, and overweight or obese with body mass index range of 25 to 40 kg/m2
Exclusion Criteria:
- pregnancy or lactation
- A history of Cardiovascular disease, Pulmonary disease, Renal disease & Celiac disease; Cirrhosis
- Following program to lose weight in recent 3 mo
Sites / Locations
- National Nutrition and Food Technology Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
hesperidin and flaxseed
control
Arm Description
Outcomes
Primary Outcome Measures
prediabetes
number of participants with normal plasma glucose
Secondary Outcome Measures
Full Information
NCT ID
NCT03737422
First Posted
October 11, 2018
Last Updated
July 24, 2019
Sponsor
National Nutrition and Food Technology Institute
1. Study Identification
Unique Protocol Identification Number
NCT03737422
Brief Title
The Effects of Hesperidin and Flaxseed in Prediabetes
Official Title
Evaluation of the Effects of Hesperidin and Flaxseed Supplementation in Patients With Prediabetes
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
October 1, 2018 (Actual)
Study Completion Date
December 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Nutrition and Food Technology Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To study the effects of Hesperidin and flaxseed supplement in patients with prediabetes, 50 patients will be randomly allocated to control group or 2 capsules Hesperidin and 30 gram flaxseed for 12 weeks; both groups will be advised to adherence the investigators' diet and exercise program too. At the first and the end of the intervention, lipid profiles, blood pressure, blood sugar, inflammatory and anthropometric factors will be assessed and compared between groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PreDiabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
hesperidin and flaxseed
Arm Type
Active Comparator
Arm Title
control
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
hesperidin and flaxseed
Intervention Description
2 capsuls hesperidin and 30 g flaxseed
Intervention Type
Other
Intervention Name(s)
control
Intervention Description
no supplementation
Primary Outcome Measure Information:
Title
prediabetes
Description
number of participants with normal plasma glucose
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age of 18 to 70 years prediabetes: impaired fasting glucose (>100 mg/dL) and/or HbA1C 5.7% to 6.5%, and overweight or obese with body mass index range of 25 to 40 kg/m2
Exclusion Criteria:
pregnancy or lactation
A history of Cardiovascular disease, Pulmonary disease, Renal disease & Celiac disease; Cirrhosis
Following program to lose weight in recent 3 mo
Facility Information:
Facility Name
National Nutrition and Food Technology Research Institute
City
Tehran
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
33402222
Citation
Yari Z, Naser-Nakhaee Z, Karimi-Shahrbabak E, Cheraghpour M, Hedayati M, Mohaghegh SM, Ommi S, Hekmatdoost A. Combination therapy of flaxseed and hesperidin enhances the effectiveness of lifestyle modification in cardiovascular risk control in prediabetes: a randomized controlled trial. Diabetol Metab Syndr. 2021 Jan 6;13(1):3. doi: 10.1186/s13098-020-00619-y.
Results Reference
derived
Learn more about this trial
The Effects of Hesperidin and Flaxseed in Prediabetes
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