NCT00916188

Brief Summary

The primary objective of this study is to evaluate the efficacy of different doses of black tea (150, 300, 450, 600 ml) in the test group compared to 150 ml in the control group, in improving oxidative stress, lipid profiles and insulin sensitivity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

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

Timeline
Completed

Started Oct 2006

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

October 1, 2006

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

June 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 9, 2009

Completed
Last Updated

July 27, 2010

Status Verified

June 1, 2009

Enrollment Period

2 months

First QC Date

June 8, 2009

Last Update Submit

July 26, 2010

Conditions

Type 2 Diabetes Mellitus

Keywords

Black TeaOxidative StressBlood LipidsInsulin Sensitivity

Outcome Measures

Primary Outcomes (1)

  • Insulin Sensitivity, oxidative Stress, lipid Profile

    4 Weeks

Study Arms (2)

Black Tea-Four Doses

EXPERIMENTAL

One, 2, 3 and 4 cups (150 ml/cup) of Black tea/day for week 1, 2, 3, and 4, respectively.

Dietary Supplement: Black Tea Extract

Black Tea-One Dose

ACTIVE COMPARATOR

One cup (150 ml) of Black tea/day during study.

Dietary Supplement: Black Tea Extract

Interventions

Black Tea ExtractDIETARY_SUPPLEMENT

Amount/dose depends on Arm assignment.

Also known as: BTE
Black Tea-Four DosesBlack Tea-One Dose

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of type 2 diabetes mellitus

You may not qualify if:

  • Intake of antioxidant supplements during previous six months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Nutrition and Food Technology Research Institute

Tehran, Tehran Province, 19395-4741, Iran

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Insulin Resistance

Interventions

Tea

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Tirang R. Neyestani, Ph.D.

    National Nutrition & Food technology Research institute, Shaheed Beheshti University (M.C.), Islamic Republic of Iran,

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 8, 2009

First Posted

June 9, 2009

Study Start

October 1, 2006

Primary Completion

December 1, 2006

Study Completion

November 1, 2007

Last Updated

July 27, 2010

Record last verified: 2009-06

Locations

IR(1)