NCT01350284

Brief Summary

The purpose of this study is to determine whether 3 g cinnamon was sufficient to delay the gastric emptying rate of a high-fat solid meal and subsequently reduce postprandial blood glucose and lipid responses, oxidative stress, arterial stiffness and satiety responses in a healthy adult population.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 3, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 9, 2011

Completed
Last Updated

May 9, 2011

Status Verified

May 1, 2011

Enrollment Period

1 month

First QC Date

May 3, 2011

Last Update Submit

May 6, 2011

Conditions

Keywords

AntioxidantsGlucose Intolerance prevention and controlDiabetes Mellitus prevention and control

Outcome Measures

Primary Outcomes (1)

  • The effect of 3grams cinnamon on gastric emptying half time

    During the 6.5 hours post ingestion

Secondary Outcomes (6)

  • Arterial stiffness

    During the 6.5 hours after ingestion

  • Lipaemia

    During the 6.5 hours after ingestion

  • Glycemia

    During the 6.5 hours after ingestion

  • Appetite

    During the 6.5 hours after ingestion

  • Oxidative stress

    During the 6.5 hours after ingestion

  • +1 more secondary outcomes

Study Arms (1)

Dietary supplementation

EXPERIMENTAL

3g of cinnamon or placebo control were added to a test-meal.

Dietary Supplement: CinnamonDietary Supplement: Placebo control

Interventions

CinnamonDIETARY_SUPPLEMENT

acute oral administration of 3 g cinnamon

Dietary supplementation
Placebo controlDIETARY_SUPPLEMENT

3 g wheat flour (placebo)- separated by 28 days from cinnamon intervention

Dietary supplementation

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adults aged 18-35 years
  • Recreationally trained individuals (participate in at least 2hrs/wk of individual/team sport)
  • Not currently taking antioxidant or lipid-lowering medication
  • Fasting blood lipid, glucose and blood pressure (BP) levels were all within the normal limits.

You may not qualify if:

  • History of gastrointestinal-related conditions, diabetes mellitus or cardiovascular disease.
  • Allergies to foods in study.
  • Blood disorder
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical Education & Sport Sciences, University of Limerick

Limerick, Ireland

Location

Related Publications (1)

  • Markey O, McClean CM, Medlow P, Davison GW, Trinick TR, Duly E, Shafat A. Effect of cinnamon on gastric emptying, arterial stiffness, postprandial lipemia, glycemia, and appetite responses to high-fat breakfast. Cardiovasc Diabetol. 2011 Sep 7;10:78. doi: 10.1186/1475-2840-10-78.

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Amir Shafat, PhD

    Univeristy of Limerick

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 3, 2011

First Posted

May 9, 2011

Study Start

June 1, 2009

Primary Completion

July 1, 2009

Study Completion

March 1, 2010

Last Updated

May 9, 2011

Record last verified: 2011-05

Locations