NCT04163757

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

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 20, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 15, 2019

Completed
Last Updated

November 15, 2019

Status Verified

November 1, 2019

Enrollment Period

2 months

First QC Date

November 12, 2019

Last Update Submit

November 14, 2019

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • type 2 diabetes

    number of participants with normal plasma glucose

    12 weeks

Study Arms (2)

placebo

PLACEBO COMPARATOR
Dietary Supplement: placebo

crocin

ACTIVE COMPARATOR
Dietary Supplement: crocin

Interventions

crocinDIETARY_SUPPLEMENT

2 tablets crocin per day

crocin
placeboDIETARY_SUPPLEMENT

2 tablets placebo per day

placebo

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • pregnancy or lactation A history of Cardiovascular disease, Pulmonary disease, Renal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Nutrition and Food Technology Research Institute

Tehran, Iran

Location

Related Publications (1)

  • 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.

    PMID: 32670418DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

crocin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 12, 2019

First Posted

November 15, 2019

Study Start

January 20, 2019

Primary Completion

March 6, 2019

Study Completion

June 3, 2019

Last Updated

November 15, 2019

Record last verified: 2019-11

Locations

IR(1)