NCT01847053

Bioavailability Study of Cinnamon in Healthy Subjects

A Single-Center, Partial Double-Blind, Randomized, Four-Treatment Crossover Bioavailability Study of Cinnamon in Healthy Subjects

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: McCormick and Company, Inc. · Industry
• Sex: Male
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Healthy Males

Interventions

Type	Name	Description
OTHER	cinnamon	Intervention will be both ground cinnamon and cinnamon extract.
OTHER	Oatmeal	Oatmeal control, around 70g; without cinnamon

Timeline

• Start date: 2013-01-01
• Primary completion: 2013-12-01
• Completion: 2014-04-01
• First posted: 2013-05-06
• Last updated: 2020-03-06

Locations

1 site across 1 country: United States