The Effects of Crocin Supplementation on Metabolic Parameters, Oxidative Stress, AMP- Activated Protein Kinase and Inflammation-promoting Genes Expression in Peripheral Blood Mononuclear Cells in Patients With Type 2 Diabetes

NCT ID: NCT04163757

Last Updated: 2019-11-15

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

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-20

Study Completion Date

2019-06-03

Brief Summary

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To study the effects of crocin supplement in patients with type 2 diabetes, 50 patients will be randomly allocated to placebo group and 2 tablets of crocin for 12 weeks. 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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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

2 tablets placebo per day

crocin

Group Type ACTIVE_COMPARATOR

crocin

Intervention Type DIETARY_SUPPLEMENT

2 tablets crocin per day

Interventions

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crocin

2 tablets crocin per day

Intervention Type DIETARY_SUPPLEMENT

placebo

2 tablets placebo per day

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

Age of 40 to 65 years type 2 diabetes: and body mass index range of 18.5 to 30 kg/m2

Exclusion Criteria

pregnancy or lactation A history of Cardiovascular disease, Pulmonary disease, Renal disease
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vahideh Behrouz

UNKNOWN

Sponsor Role collaborator

Ali Dastkhosh

UNKNOWN

Sponsor Role collaborator

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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Behrouz V, Dastkhosh A, Hedayati M, Sedaghat M, Sharafkhah M, Sohrab G. The effect of crocin supplementation on glycemic control, insulin resistance and active AMPK levels in patients with type 2 diabetes: a pilot study. Diabetol Metab Syndr. 2020 Jul 9;12:59. doi: 10.1186/s13098-020-00568-6. eCollection 2020.

Reference Type DERIVED
PMID: 32670418 (View on PubMed)

Other Identifiers

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899

Identifier Type: -

Identifier Source: org_study_id

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