Bioavailability Study of Cinnamon in Healthy Subjects

Status Completed

Clinical Trial Summary

A partial double-blind, randomized, placebo-controlled, 4-treatment crossover study design will be used to evaluate bioavailability of various forms of cinnamon and to determine the effects of 3 and 6 g of cinnamon added to instant oatmeal on blood glucose levels in 8 healthy subjects. In the extended dose response study, three subjects will continue the study and be offered 5 day consecutive feedings of 9 g cinnamon extract and on Day 6, and blood samples would be collected over 6 hours after a single morning dose. Urinary samples would be collected upon to 48 hours.

Clinical Trial Description

Objective:

The objective of this trial is to evaluate the bioavailability of selected procyanidin derived metabolites from various forms of cinnamon.

Study Products:

Core Study

- Control: Oatmeal (~70 g) without cinnamon

- Active A: Oatmeal (~70 g) with 3 g ground cinnamon

- Active B: Oatmeal (~70 g) with 3 g cinnamon extract

- Active C: Oatmeal (~70 g) with 6 g cinnamon extract

Extension Study

•9 g cinnamon extract in capsule form (unblinded) The 9 g/d cinnamon extract will be consumed by subjects on days 22 through 26. At visit 6 (day 27), subjects will return to the clinic for the test day. The cinnamon extract capsule (9 g) will be consumed with an oatmeal (70 g) breakfast.

Subjects:

Subjects will be healthy men 18 - 40 years of age (inclusive), each with a body mass index (BMI) 25.00-29.99 kg/m2.

Outcome Variables:

Primary Outcome Variable The primary outcome variables will be the area under the curve (AUC) from 0 to 360 min for plasma procyanidin-derived metabolites, where t=0 min is the start of study product consumption.

Secondary Outcome Variables

Secondary outcome variables will include the assessment of:

- The maximum concentration (Cmax) and time to reach peak concentration (Tmax) for plasma procyanidin-derived metabolites, as well as the net incremental AUC values to account for possible non-zero pre-load values.

- The effect of a single dose of cinnamon on the metabolic profile using an untargeted metabolomics analysis on both plasma and urine specimens.

- The effect of a single dose of cinnamon on plasma glucose and insulin. ;

Study Design

Related Conditions & MeSH terms

Healthy Males

Clinical Trial Details

NCT number	NCT01847053
Study type	Interventional
Source	McCormick and Company, Inc.
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	January 2013
Completion date	April 2014

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.