The Effect of Natural Food Flavourings on Gastrointestinal and Cardiovascular Physiological Responses.

NCT ID: NCT01350284

Last Updated: 2011-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-03-31

Brief Summary

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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.

Detailed Description

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Cinnamon has been shown to delay gastric emptying (GE) of a high-carbohydrate meal and reduce postprandial glycaemia in healthy adults. However, it is dietary fat which is implicated in the etiology and is associated with obesity, type 2 diabetes (T2D) and cardiovascular disease (CVD). We aimed to determine the effect of 3 g cinnamon on GE, postprandial lipemic and glycemic responses, oxidative stress, arterial stiffness, as well as appetite sensations and subsequent food intake following a high-fat (HF) meal.

The effect of acute oral administration of 3 g cinnamon on gastric emptying of a high-fat pancake test meal and subjective appetite sensations by visual analogue scale will be measured for six hours postprandially. During this time course, measurements of postprandial lipemic, glycemic, oxidative stress and arterial stiffness responses will be collected. Subsequently, food intake will be measured using an ad libitum buffet meal. The study will be conducted in a randomized, placebo-controlled, single-blinded manner in 9 healthy subjects.

Conditions

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Gastric Emptying Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Dietary supplementation

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

Group Type EXPERIMENTAL

Cinnamon

Intervention Type DIETARY_SUPPLEMENT

acute oral administration of 3 g cinnamon

Placebo control

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Cinnamon

acute oral administration of 3 g cinnamon

Intervention Type DIETARY_SUPPLEMENT

Placebo control

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

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

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Ulster

OTHER

Sponsor Role collaborator

Ulster Hospital, Northern Ireland

UNKNOWN

Sponsor Role collaborator

National University of Ireland, Galway, Ireland

OTHER

Sponsor Role collaborator

University of Limerick

OTHER

Sponsor Role lead

Responsible Party

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University of Limerick

Principal Investigators

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Amir Shafat, PhD

Role: PRINCIPAL_INVESTIGATOR

Univeristy of Limerick

Locations

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Department of Physical Education & Sport Sciences, University of Limerick

Limerick, , Ireland

Site Status

Countries

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Ireland

References

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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.

Reference Type DERIVED
PMID: 21899741 (View on PubMed)

Other Identifiers

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CinnGastEmpt

Identifier Type: -

Identifier Source: org_study_id

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