NCT03734874

Brief Summary

To study the effects of Hesperidin supplement in patients with metabolic syndrome, 50 patients will be randomly allocated to control group or 2 capsules Hesperidin 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, metabolic factors will be assessed and compared between groups.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

June 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2018

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 8, 2018

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

November 8, 2018

Status Verified

November 1, 2018

Enrollment Period

5 months

First QC Date

October 11, 2018

Last Update Submit

November 7, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Metabolic syndrome: Number of participants with treated metabolic syndrome

    number of participants with treated metabolic syndrome

    12 weeks

Study Arms (2)

hesperidin

ACTIVE COMPARATOR
Dietary Supplement: hesperidin

control

PLACEBO COMPARATOR
Other: control

Interventions

hesperidinDIETARY_SUPPLEMENT

500 mg hesperidin as two capsuls

hesperidin
controlOTHER

no supplementation

control

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age of 18 to 70 years
  • having 3 of 5 of high blood sugar, hypertension, high TG, high waist circumference, low HDL

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

RECRUITING

Related Publications (1)

  • Yari Z, Movahedian M, Imani H, Alavian SM, Hedayati M, Hekmatdoost A. The effect of hesperidin supplementation on metabolic profiles in patients with metabolic syndrome: a randomized, double-blind, placebo-controlled clinical trial. Eur J Nutr. 2020 Sep;59(6):2569-2577. doi: 10.1007/s00394-019-02105-2. Epub 2019 Dec 16.

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Hesperidin

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

FlavanonesFlavonoidsChromonesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingGlycosidesCarbohydrates

Central Study Contacts

azita Hekmatdoost, MD.PhD

CONTACT

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 8, 2018

Study Start

June 1, 2018

Primary Completion

November 1, 2018

Study Completion

December 1, 2018

Last Updated

November 8, 2018

Record last verified: 2018-11

Locations