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

This study has been completed.

Sponsor:

Collaborators:

University of Ulster

Ulster Hospital, Northern Ireland

National University of Ireland, Galway, Ireland

Information provided by:

University of Limerick

ClinicalTrials.gov Identifier:

NCT01350284

First received: May 3, 2011

Last updated: May 6, 2011

Last verified: May 2011

History of Changes

Purpose

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.

Condition	Intervention
Gastric Emptying Diabetes Mellitus	Dietary Supplement: Cinnamon Dietary Supplement: Placebo control


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single Blind (Participant) Primary Purpose: Basic Science
Official Title:	Effect of Cinnamon on Gastric Emptying, Arterial Stiffness, Postprandial Lipaemia, Glycaemia, and Appetite Responses to High-fat Breakfast

Further study details as provided by University of Limerick:

Primary Outcome Measures:

The effect of 3grams cinnamon on gastric emptying half time [ Time Frame: During the 6.5 hours post ingestion ]

Secondary Outcome Measures:

Arterial stiffness [ Time Frame: During the 6.5 hours after ingestion ]
Post-prandial changes in pulse wave velocity (m/s) will be measured non-invasively, using Pulsetrace PSA2 to indicate arterial stiffness.
Lipaemia [ Time Frame: During the 6.5 hours after ingestion ]
Plasma concentration (mmol/l) of triacylglycerols, LDL, and HDL will be measured every hour in the post-prandial period.
Glycemia [ Time Frame: During the 6.5 hours after ingestion ]
The concentration of plasma glucose (mmol/l) will measured hourly in the postprandial period, using venous blood drawn from a forearm vein.
Appetite [ Time Frame: During the 6.5 hours after ingestion ]
Subjective sensation of hunger, desire to eat, fullness, thirst, tiredness and coldness will be meaured using a 150mm visual analogue scale (mm).
Oxidative stress [ Time Frame: During the 6.5 hours after ingestion ]
Serum lipidhydroperoxides will be measured using FOX-1 assay.
Food intake [ Time Frame: 6 hours post-prandially ]
A buffet meal will be presented to the volunteer 6h after breakfast. Food intake will be monitored covertly by weighing individiual food items before and after presentation. Food intake will be expressed as macronutrient (carbohydrate, fat, protein, water, fibre) and energy intake.


Enrollment:	9
Study Start Date:	June 2009
Study Completion Date:	March 2010
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Dietary supplementation 3g of cinnamon or placebo control were added to a test-meal.	Dietary Supplement: Cinnamon acute oral administration of 3 g cinnamon Dietary Supplement: Placebo control 3 g wheat flour (placebo)- separated by 28 days from cinnamon intervention

Detailed Description:

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.

Eligibility


Ages Eligible for Study:	18 Years to 35 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01350284

Locations


Ireland
Department of Physical Education & Sport Sciences, University of Limerick
Limerick, Ireland

Sponsors and Collaborators

University of Limerick

University of Ulster

Ulster Hospital, Northern Ireland

National University of Ireland, Galway, Ireland

Investigators


Principal Investigator:	Amir Shafat, PhD	Univeristy of Limerick

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Amir Shafat, PhD, University of Limerick
ClinicalTrials.gov Identifier:	NCT01350284 History of Changes
Other Study ID Numbers:	CinnGastEmpt
Study First Received:	May 3, 2011
Last Updated:	May 6, 2011

Keywords provided by University of Limerick:


Antioxidants Glucose Intolerance prevention and control Diabetes Mellitus prevention and control

Additional relevant MeSH terms:


Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases

ClinicalTrials.gov processed this record on July 19, 2017

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