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DiabetesPhase 1NCT00262145

Ability of a Tea Leaf Extracts Preparation to Slow Down Carbohydrate and Fat Absorption

A Phase 1 study testing tea extracts in people with Diabetes and Overweight, run by NatureGen at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Diabetes, Overweight
What is being tested?
tea extracts
How many people
20 participants
Where
1 siteUnited States
Study dates
Oct 2005to Nov 2005
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 18 to 60 years old, healthy individuals

Who cannot join

  • pregnant women

Trial locations and contacts

1 site in 1 country.

United States1 site
  • VA Medical Center

    Minneapolis, Minnesota, 55417

Other trials in United States

About this study

Official title: Ability of a Tea Leaf Extracts Preparation to Slow Down Carbohydrate and Fat Uptake in Human

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 lipid malabsorption. Objective evidence that the tea leaf extract actually induces carbohydrate and/or fat malabsorption could provide the basis for further studies.

Read the detailed description

One of the commonly cited beneficial effects of tea is its ability to induce weight loss. Support for this contention include a controlled human trial showing increased weight loss when tea was added to a dietary regimen, and a mouse study demonstrating that administration of a tea extract with a high fat diet eliminated the weight gain observed in the absence of tea. Several different mechanisms have been postulated to account for this weight control. Multiple studies have reported modest increases in energy expenditure associated with ingestion of oolong or green teas. In addition, tea could inhibit the absorption of carbohydrate and/or fat. Studies supporting the possibility of carbohydrate malabsorption include a in vitro studies showing that constituents of tea inhibit the activity of carbohydrate digesting enzymes (α-amylase and α-glucosidase, and the mucosal uptake of glucose via an interaction with sodium dependent glucose transporters. The in vitro demonstration that tea extracts inhibit pancreatic lipase activity suggests that tea might interfere with triglyceride absorption.

However, there have been no in vivo studies in humans or animals showing that tea preparations actually are capable of causing malabsorption of either carbohydrate or fat. In the present study, we utilized measurements of breath H2 and 13CO2 to investigate the ability of a mixture of black, green and mulberry tea leaf extracts to induce malabsorption of carbohydrate and fat in healthy volunteers.

Protocol - The study group consisted of 20 healthy volunteers (ages 23 to 52, 10 females and 10 males). The subjects fasted after their usual dinner on the day preceding the study until the following morning (approximately 8 am) when the experiments were performed. After collection of baseline breath samples for H2 and 13CO2 analysis, the subjects ingested the test meal that consisted of cooked white rice and butter. The rice was boiled for20 minutes, and then individual portions (176 g, which contained 50 g of carbohydrate) were weighed and frozen with 10g of butter. Immediately prior to ingestion, the meals were warmed in a microwave oven, and 0.2 g of 1,1,1-13C-triolein (Cambridge Isotope Laboratories, Andover, MA) was thoroughly mixed into the meal. Concurrent with ingestion of the meal, the subjects randomly were assigned to drink either 500 ml of the warm active tea preparation containing 10 g of sucrose or 500 ml of a placebo preparation that also contained 10 g of sucrose. Breath samples were then collected at hourly intervals for eight hours. At the end of each test period, subjects were asked to rate a variety of symptoms including nausea, bloating, abdominal discomfort, and rectal gas (as well as obfuscating symptoms) on a previously described linear scale that ranged from zero (none) to 4 (severe). In addition, the number of loose bowel movements were noted. One week later the test was repeated with the subjects receiving the opposite preparation from that used in the initial study. The study was approved by the Human Studies Subcommittee of the Mpls. VA Medical center and informed consent was obtained from all subjects.

Conditions
Diabetes, Overweight
Being tested
tea extracts
Keywords
glucose, lipid, diabetes, overweight
Medical subject headings
Diabetes Mellitus, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tea extractsDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. glucose and lipid uptake

Secondary outcomes (1)
  1. lipid metabolism

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2005 (estimated)
  2. Study startOct 2005
  3. Study completionNov 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Enrolment
20 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00262145
Sponsor's protocol ID
NA051001
Status last verified
Oct 2005
First submitted
5 Dec 2005
Last updated
6 Dec 2005
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing tea extracts in people with Diabetes and Overweight, run by NatureGen at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Dec 2005. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

glucose and lipid uptake. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2005.

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