NCT03813914

Brief Summary

This study evaluates the effect of a combination of glycirrhizic acid, Cinnamomun Zeylanicum and corosolic acid for the treatment of metabolic syndrome. Participants receive the supplement or a placebo.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 7, 2018

Completed
6 months until next milestone

First Posted

Study publicly available on registry

January 23, 2019

Completed
Last Updated

January 23, 2019

Status Verified

January 1, 2019

Enrollment Period

1 year

First QC Date

August 7, 2018

Last Update Submit

January 21, 2019

Conditions

Metabolic Syndrome

Keywords

insulin resistance, blood pressure,

Outcome Measures

Primary Outcomes (2)

  • Changes in glycemia

    Reduction of glycemia (mg/dl)

    3 months

  • Changes in HDL-cholesterol

    Increase of HDL-C (mg/dl)

    3 months

Secondary Outcomes (3)

  • changes in HOMA-IR

    3 months

  • changes in total-cholesterol

    3 months

  • changes in triglycerides

    3 months

Study Arms (2)

Sineos

EXPERIMENTAL

Glycyrrhizic acid 38 mg + Cinnamomum Zeylanicum 150 mg + corosolic acid 480 mcg 2 pills/day for 3 months

Dietary Supplement: Sineos

Placebo comparator

PLACEBO COMPARATOR

placebo 2 pills/day for 3 months

Dietary Supplement: Sineos

Interventions

SineosDIETARY_SUPPLEMENT

glycyrrhizic acid 38 mg + Cinnamomum Zeylanicum 150 mg + corosolic acid 480 mcg 2 pills per day

Placebo comparatorSineos

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Metabolic SyndromeInsulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Clinical professor

Study Record Dates

First Submitted

August 7, 2018

First Posted

January 23, 2019

Study Start

January 15, 2017

Primary Completion

January 15, 2018

Study Completion

June 30, 2018

Last Updated

January 23, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share