The Effects of Hesperidin and Flaxseed in Prediabetes

NCT ID: NCT03737422

Last Updated: 2019-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2018-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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PreDiabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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hesperidin and flaxseed

Group Type ACTIVE_COMPARATOR

hesperidin and flaxseed

Intervention Type DIETARY_SUPPLEMENT

2 capsuls hesperidin and 30 g flaxseed

control

Group Type PLACEBO_COMPARATOR

control

Intervention Type OTHER

no supplementation

Interventions

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hesperidin and flaxseed

2 capsuls hesperidin and 30 g flaxseed

Intervention Type DIETARY_SUPPLEMENT

control

no supplementation

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Nutrition and Food Technology Institute

OTHER

Sponsor Role lead

Responsible Party

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Dr Azita Hekmatdoost

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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National Nutrition and Food Technology Research Institute

Tehran, , Iran

Site Status

Countries

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Iran

References

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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.

Reference Type DERIVED
PMID: 33402222 (View on PubMed)

Other Identifiers

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6781

Identifier Type: -

Identifier Source: org_study_id

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