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

Effect of Cinnamon on Gastric Emptying, Arterial Stiffness, Postprandial Lipaemia, Glycaemia, and Appetite Responses to High-fat Breakfast

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus; Gastric Emptying
• Intervention / Treatment: Dietary supplement: Cinnamon; Dietary supplement: Placebo control

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The effect of 3grams cinnamon on gastric emptying half time	During the 6.5 hours post ingestion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterial stiffness	Post-prandial changes in pulse wave velocity (m/s) will be measured non-invasively, using Pulsetrace PSA2 to indicate arterial stiffness.	During the 6.5 hours after ingestion
Lipaemia	Plasma concentration (mmol/l) of triacylglycerols, LDL, and HDL will be measured every hour in the post-prandial period.	During the 6.5 hours after ingestion
Glycemia	The concentration of plasma glucose (mmol/l) will measured hourly in the postprandial period, using venous blood drawn from a forearm vein.	During the 6.5 hours after ingestion
Appetite	Subjective sensation of hunger, desire to eat, fullness, thirst, tiredness and coldness will be meaured using a 150mm visual analogue scale (mm).	During the 6.5 hours after ingestion
Oxidative stress	Serum lipidhydroperoxides will be measured using FOX-1 assay.	During the 6.5 hours after ingestion
Food intake	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.	6 hours post-prandially

Collaborators and Investigators

• Sponsor: University of Limerick
• Collaborators: National University of Ireland, Galway, Ireland; University of Ulster; Ulster Hospital, Northern Ireland
• Investigators: Principal Investigator: Amir Shafat, PhD, Univeristy of Limerick

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (ACTUAL): July 1, 2009
• Study Completion (ACTUAL): March 1, 2010

Study Registration Dates

• First Submitted: May 3, 2011
• First Submitted That Met QC Criteria: May 6, 2011
• First Posted (ESTIMATE): May 9, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): May 9, 2011
• Last Update Submitted That Met QC Criteria: May 6, 2011
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Keywords: Antioxidants; Glucose Intolerance prevention and control; Diabetes Mellitus prevention and control
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: CinnGastEmpt