NCT00389350

Brief Summary

The objective of this study was to determine if taking an extract of green tea for three months could improve glucose control in adults with diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for phase_2 diabetes

Timeline
Completed

Started Aug 2005

Shorter than P25 for phase_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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 18, 2006

Completed
Last Updated

October 13, 2023

Status Verified

October 1, 2023

First QC Date

October 16, 2006

Last Update Submit

October 12, 2023

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

  • HbA1c

Interventions

Extract of Green and Black TeaDRUG
Also known as: Placebo Arm

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults with Diabetes not taking insulin

You may not qualify if:

  • pregnancy, warfarin therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Tea

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Todd A MacKenzie, PhD

    Dartmouth-Hitchcock Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator, Professor, Data Science

Study Record Dates

First Submitted

October 16, 2006

First Posted

October 18, 2006

Study Start

August 1, 2005

Study Completion

June 1, 2006

Last Updated

October 13, 2023

Record last verified: 2023-10

Locations

US(1)