Klamath Falls, Oregon 97601


Purpose:

This is a randomized, controlled, cross-over study on the effects of consumption of Deepure puerh tea extract (PTE) on glucose tolerance and metabolic markers.


Study summary:

The study will involve consuming three different doses: 1 gram, 1.5 grams, and 2 grams, and will be given in warm water, with a bland meal. The effects on glucose and insulin after consumption will be evaluated.The subjects will be randomly assigned to one of four groups with different sequences.


Criteria:

Inclusion Criteria: - Men and women; - Aged 18-70 years; - BMI between 20-30; - Fasting blood glucose at screening between 71-125 mg/dL. both inclusive. Exclusion Criteria: - Taking dietary supplements judged to interfere with the effects of Deepure on glucose metabolism (for example: cinnamon extract; chromium picolinate; mulberry extract; bitter melon extract, green tea extracts, black tea extracts, pu-erh tea); - Participation in other clinical trials, involving an investigational product or lifestyle change, during the last month; - Participation in another research study during this trial, involving an investigational product or lifestyle change; Taking prescription medication known to affect glucose metabolism; - Taking over-the-counter medication known to affect glucose metabolism; - Drinking 3 or more cups of tea daily; - Unwilling to abstain from drinking tea for 24 hours before clinic visits; (if a person drinks tea within 24 hours of a clinic visit, the person's visit will be re-scheduled); - Consuming 2 or more drinks of alcohol per day; - Unwilling to abstain from drinking alcohol for 10 hours before clinic visits; - Diagnosed with diabetes Type I; Taking medication for diabetes Type II; - Diagnosed with the thyroid disorder Hashimoto's disease; - Past major surgery to your stomach or intestines (minor surgery not a problem such as hernia repair, appendix removal, gallbladder removal); - Currently taking cholesterol-lowering medication (for example: statins); - Currently taking coumadin; - Major trauma within the past 6 months; - Major surgery within the past 6 months; - Severe chronic infectious disease (such as HIV, chronic hepatitis); - Active depression; - Self-reported eating disorders; - History of drug abuse during past two years; - Currently going through intense stressful events or life changes; - Women of child-bearing potential: Pregnant, breast-feeding, or trying to become pregnant; - Women of child-bearing potential: Not using effective contraception; - Food allergies or sensitivities to tea.


NCT ID:

NCT03613688


Primary Contact:

Gitte Jensen
Phone: (541) 884-0112
Email: gitte@nislabs.com


Backup Contact:

N/A


Location Contact:

Klamath Falls, Oregon 97601
United States

Gitte Jensen
Phone: 541-884-0112
Email: gitte@nislabs.com

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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