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NCT00262145 · ClinicalTrials.gov registry record · Phase 1
Ability of a Tea Leaf Extracts Preparation to Slow Down Carbohydrate and Fat Absorption
A Phase 1 study of Diabetes and Overweight, sponsored by NatureGen.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT00262145 is a Phase 1 study of Diabetes and Overweight that has completed, run by NatureGen. The registered enrollment target is 20 participants, below the 3,028-participant average among 338 other Diabetes trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00262145, a Phase 1 study of Diabetes and Overweight, has completed, sponsored by NatureGen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
Objective - A variety of herbal, over-the-counter preparations of tea leaves are said to reduce the rate of absorption of fat ( allegedly via inhibition of pancreatic lipase) and carbohydrate (via inhibition of carbohydrate digestion and blocking of glucose transport by the intestinal mucosa). There has been some study of the ability of these products to reduce the blood glucose increase observed after a carbohydrate meal and to reduce blood cholesterol levels in chronic studies. The purpose of the present study is to objectively determine if one cup of "tea" made from a combination of three types of tea leaves (mulberry, black and green tea) can cause malabsorption of carbohydrate and fat taken in conjunction with the tea. Research Design - The study will consist of a double blind, placebo controlled crossover study in 20 healthy subjects. On one of two days (one week apart) the subjects will ingest a standard meal consisting of 30 g of sucrose (in the tea) and 30 g of starch in the form of white rice plus 10 g of fat as butter. To measure triglyceride absorption, each meal will also contain 250 mg of 13-C labeled triolein. Triolein is a commonly ingested fat consisting of glycerol bound to three oleic acids. 13-C is a stable (non-radioactive) isotope of carbon. On one of the test days the subjects (randomly) will concurrently consume the active preparation, a tea containing extracts of the three types of tea leave described above plus the meal, and on the other test day they will consume the meal with a liquid placebo preparation (warm water, sugar and food coloring). Subjects will provide a breath sample before and at hourly intervals for 8 hours after ingestion of the meal. Carbohydrate malabsorption will be determined by the hydrogen concentration in the breath samples and fat malabsorption by the concentration of 13-CO2 in the breath samples. Clinical Significance - An increase in breath hydrogen indicates carbohydrate malabsoption and a low 13-CO2 indicates
Conditions Studied
Interventions
- DRUG tea extracts
Study Locations (1)
Minnesota
- VA Medical Center - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2005-10 |
| Est. Completion | 2005-11 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00262145
The ClinicalTrials.gov registry entry for NCT00262145 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,028-participant average among 338 other Diabetes trials with a reported enrollment target (99% lower). The listed sponsor is NatureGen, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Diabetes appearing as the primary indexed condition, and to 1 intervention - of which tea extracts is the first listed.
NCT00262145 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.
Frequently Asked Questions
What is clinical trial NCT00262145 about?
NCT00262145 is a clinical study titled "Ability of a Tea Leaf Extracts Preparation to Slow Down Carbohydrate and Fat Absorption". Objective - A variety of herbal, over-the-counter preparations of tea leaves are said to reduce the rate of absorption of fat ( allegedly via inhibition of pancreatic lipase) and carbohydrate (via inhibition of carbohydrate digestion and blocking of glucose transport by the intestinal mucosa). There...
What is the current status of trial NCT00262145?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2005-10. Estimated completion is 2005-11.
What conditions does trial NCT00262145 study?
This clinical trial studies the following conditions: Diabetes, Overweight.
What interventions are being tested in trial NCT00262145?
The interventions under investigation include: tea extracts (DRUG).
Who is sponsoring clinical trial NCT00262145?
This trial is sponsored by NatureGen, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00262145 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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