The Effects of Hesperidin and Flaxseed in Prediabetes
Evaluation of the Effects of Hesperidin and Flaxseed Supplementation in Patients With Prediabetes
1 other identifier
interventional
48
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2018
CompletedFirst Submitted
Initial submission to the registry
October 11, 2018
CompletedFirst Posted
Study publicly available on registry
November 9, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedJuly 26, 2019
November 1, 2018
9 months
October 11, 2018
July 24, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
prediabetes
number of participants with normal plasma glucose
12 weeks
Study Arms (2)
hesperidin and flaxseed
ACTIVE COMPARATORcontrol
PLACEBO COMPARATORInterventions
2 capsuls hesperidin and 30 g flaxseed
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- pregnancy or lactation
- A history of Cardiovascular disease, Pulmonary disease, Renal disease \& Celiac disease; Cirrhosis
- Following program to lose weight in recent 3 mo
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Nutrition and Food Technology Research Institute
Tehran, Iran
Related Publications (1)
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.
PMID: 33402222DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 11, 2018
First Posted
November 9, 2018
Study Start
January 1, 2018
Primary Completion
October 1, 2018
Study Completion
December 1, 2018
Last Updated
July 26, 2019
Record last verified: 2018-11